BETHANECHOL CHLORIDE tablet

1. No Title 1572549268
2. No Title 1572550142
3. No Title 1572550442
4. No Title 1572553529
5. Bethanechol Chloride Tablets, Usp5 Mg, 10 Mg, 25 Mg And 50 Mg
6. Description
7. Clinical Pharmacology
8. Indications And Usage
9. Contraindications
10. Precautions
11. Adverse Reactions
12. Overdosage
13. Dosage And Administration
14. How Supplied
15. Principal Display Panel - 5 Mg Tablet Bottle Label
16. Principal Display Panel - 10 Mg Tablet Bottle Label
17. Principal Display Panel - 25 Mg Tablet Bottle Label
18. Principal Display Panel - 50 Mg Tablet Bottle Label
19. No Title 1572449690
20. Indications & Usage
21. Dosage & Administration
22. Package Label.principal Display Panel
23. No Title 1572449831
24. Bethanechol Chloride 10mg Tablet
25. Description
26. Clinical Pharmacology
27. Indications And Usage
28. Contraindications
29. Precautions
30. Adverse Reactions
31. Overdosage
32. Dosage And Administration
33. How Supplied
34. Package Label.principal Display Panel 5 Mg
35. Package Label.principal Display Panel 10 Mg
36. Package Label.principal Display Panel 25 Mg
37. Package Label.principal Display Panel 50 Mg
38. Package Label.principal Display Panel
39. No Title 1572452466
40. Description:
41. Clinical Pharmacology:
42. Indications And Usage:
43. Contraindications:
44. Precautions:
45. Adverse Reactions:
46. Overdosage:
47. Dosage And Administration:
48. How Supplied:
49. Principal Display Panel
50. Package/label Display Panel
51. No Title 1572452649
52. Packaging Information
53. Package/label Display Panel Carton 10 Mg
54. Package/label Display Panel Blister 10 Mg
55. Package/label Display Panel Carton 25 Mg
56. Package/label Display Panel Blister 25 Mg
57. Description
58. Principal Display Panel 5 Mg Container Label
59. Principal Display Panel 10 Mg Container Label
60. Principal Display Panel 25 Mg Container Label
61. Principal Display Panel 50 Mg Container Label
62. Product Informationbethanechol Chloride Tablets, Usp
63. References
64. Package/label Display Panel

No Title 1572549268 ⮝

Full Prescribing Information

No Title 1572550142 ⮝

Bethanechol Chloride

Tablets, USP

Rx only

No Title 1572550442 ⮝

Full Prescribing Information

No Title 1572553529 ⮝

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

Manufactured by:

Amneal Pharmaceuticals
Paterson, New Jersey 07504

Rx Only

Rev.04-2011

Bethanechol Chloride Tablets, Usp5 Mg, 10 Mg, 25 Mg And 50 Mg  ⮝

Rx only

Description  ⮝

Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine.

It is designated chemically as 2-[(aminocarbonyl) oxy]-N, N,N-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN202 and its structural formula is:

It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68.

Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 25 mg and 50 mg tablets also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake.

Clinical Pharmacology  ⮝

Bethanechol chloride acts principally by producing the effects of stimulation of the parasympathetic nervous system. It increases the tone of the detrusor urinae muscle, usually producing a contraction sufficiently strong to initiate micturition and empty the bladder. It stimulates gastric motility, increases gastric tone and often restores impaired rhythmic peristalsis.

Stimulation of the parasympathetic nervous system releases acetylcholine at the nerve endings. When spontaneous stimulation is reduced and therapeutic intervention is required, acetylcholine can be given, but it is rapidly hydrolyzed by cholinesterase and its effects are transient. Bethanechol chloride is not destroyed by cholinesterase and its effects are more prolonged than those of acetylcholine.

Effects on the Gl and urinary tracts sometimes appear within 30 minutes after oral administration of bethanechol chloride, but more often 60 to 90 minutes are required to reach maximum effectiveness. Following oral administration, the usual duration of action of bethanechol is one hour, although large doses (300 to 400 mg) have been reported to produce effects for up to six hours. Subcutaneous injection produces a more intense action on bladder muscle than does oral administration of the drug.

Because of the selective action of bethanechol, nicotinic symptoms of cholinergic stimulation are usually absent or minimal when orally or subcutaneously administered in therapeutic doses, while muscarinic effects are prominent. Muscarinic effects usually occur within 5 to 15 minutes after subcutaneous injection, reach a maximum in 15 to 30 minutes, and disappear within two hours. Doses that stimulate micturition and defecation and increase peristalsis do not ordinarily stimulate ganglia or voluntary muscles. Therapeutic test doses in normal human subjects have little effect on heart rate, blood pressure or peripheral circulation.

Bethanechol chloride does not cross the blood-brain barrier because of its charged quaternary amine moiety. The metabolic rate and mode of excretion of the drug have not been elucidated.

A clinical study (Diokno, A.C.; Lapides, J.; Urol 10: 23-24, July 1977) was conducted on the relative effectiveness of oral and subcutaneous doses of bethanechol chloride on the stretch response of bladder muscle in patients with urinary retention. Results showed that 5 mg of the drug given subcutaneously stimulated a response that was more rapid in onset and of larger magnitude than an oral dose of 50 mg, 100 mg, or 200 mg. All the oral doses, however, had a longer duration of effect than the subcutaneous dose. Although the 50 mg oral dose caused little change in intravesical pressure in this study, this dose has been found in other studies to be clinically effective in the rehabilitation of patients with decompensated bladders.

Indications And Usage  ⮝

Bethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

Contraindications  ⮝

Hypersensitivity to bethanechol chloride tablets, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, epilepsy and parkinsonism.

Bethanechol chloride should not be employed when the strength or integrity of the gastrointestinal or bladder wall is in question, or in the presence of mechanical obstruction; when increased muscular activity of the gastrointestinal tract or urinary bladder might prove harmful, as following recent urinary bladder surgery, gastrointestinal resection and anastomosis, or when there is possible gastrointestinal obstruction; in bladder neck obstruction, spastic gastrointestinal disturbances, acute inflammatory lesions of the gastrointestinal tract, or peritonitis; or in marked vagotonia.

Precautions  ⮝

General: In urinary retention, if the sphincter fails to relax as bethanechol contracts the bladder, urine may be forced up the ureter into the kidney pelvis. If there is bacteriuria, this may cause reflux infection.

Information for Patients: Bethanechol chloride tablets should preferably be taken one hour before or two hours after meals to avoid nausea or vomiting. Dizziness, lightheadedness or fainting may occur, especially when getting up from a lying or sitting position.

Drug Interactions: Special care is required if this drug is given to patients receiving ganglion blocking compounds because a critical fall in blood pressure may occur. Usually, severe abdominal symptoms appear before there is such a fall in the blood pressure.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of bethanechol chloride.

Pregnancy: Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with bethanechol chloride. It is also not known whether bethanechol chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bethanechol chloride should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether this drug is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions from bethanechol chloride in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions  ⮝

Adverse reactions are rare following oral administration of bethanechol, but are more common following subcutaneous injection. Adverse reactions are more likely to occur when dosage is increased.

The following adverse reactions have been observed: Body as a Whole: malaise; Digestive: abdominal cramps or discomfort, colicky pain, nausea and belching, diarrhea, borborygmi, salivation; Renal: urinary urgency; Nervous System: headache; Cardiovascular: a fall in blood pressure with reflex tachycardia, vasomotor response; Skin: flushing producing a feeling of warmth, sensation of heat about the face, sweating Respiratory: bronchial constriction, asthmatic attacks Special Senses: lacrimation, miosis.

Causal Relationship Unknown: The following adverse reactions have been reported, and a causal relationship to therapy with bethanechol has not been established: Body as a Whole: malaise; Nervous System: seizures.

Overdosage  ⮝

Early signs of overdosage are abdominal discomfort, salivation, flushing of the skin ( hot feeling ), sweating, nausea, and vomiting.

Atropine Sulfate is a specific antidote. The recommended dose for adults is 0.6 mg. Repeat doses can be given every two hours, according to clinical response. The recommended dosage in infants and children up to 12 years of age is 0.01 mg/kg (to a maximum single dose of 0.4 mg) repeated every two hours as needed until the desired effect is obtained or adverse effects of atropine preclude further usage. Subcutaneous injection of atropine is preferred except in emergencies when the intravenous route may be employed.

The oral LD50 of bethanechol chloride is 1510 mg/kg in the mouse.

Dosage And Administration  ⮝

Dosage must be individualized, depending on the type and severity of the condition to be treated.

Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur.

The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour.

If necessary, the effects of the drug can be abolished promptly by atropine [see OVERDOSAGE].

How Supplied  ⮝

Bethanechol Chloride Tablets, USP

5 mg - White, round, scored tablets. Debossed AN 571

10 mg - White, round, scored tablets. Debossed AN 572

25 mg - Yellow, round, scored tablets in blistercards of 30. Debossed AN 573

50 mg - Yellow round, scored tablets. Debossed AN 574

This container not intended for household use. Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP.

Store at 20 C to 25 C (68 F to 77 F); excursions permitted to 15 C-30 C (59 F-86 F).
[See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Principal Display Panel - 5 Mg Tablet Bottle Label ⮝

NDC 0832-0510-00

Bethanechol
Chloride
Tablets, USP

5 mg

100 Tablets
Rx only

UPSHER-SMITH

Principal Display Panel - 10 Mg Tablet Bottle Label ⮝

NDC 0832-0511-00

Bethanechol
Chloride
Tablets, USP

10 mg

100 Tablets
Rx only

UPSHER-SMITH

Principal Display Panel - 25 Mg Tablet Bottle Label ⮝

NDC 0832-0512-00

Bethanechol
Chloride
Tablets, USP

25 mg

100 Tablets
Rx only

UPSHER-SMITH

Principal Display Panel - 50 Mg Tablet Bottle Label ⮝

NDC 0832-0513-00

Bethanechol
Chloride
Tablets, USP

50 mg

100 Tablets
Rx only

UPSHER-SMITH

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0832-0510 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bethanechol Chloride (UNII: H4QBZ2LO84) (Bethanechol - UNII:004F72P8F4) Bethanechol Chloride 5 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) lactose monohydrate (UNII: EWQ57Q8I5X) magnesium stearate (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code BCL;5;832 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0832-0510-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010 2 NDC:0832-0510-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010 3 NDC:0832-0510-01 100 in 1 CARTON 01/24/2010 3 NDC:0832-0510-89 1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040633 01/24/2010

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0832-0511 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bethanechol Chloride (UNII: H4QBZ2LO84) (Bethanechol - UNII:004F72P8F4) Bethanechol Chloride 10 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) lactose monohydrate (UNII: EWQ57Q8I5X) magnesium stearate (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code BCL;10;832 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0832-0511-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010 2 NDC:0832-0511-25 250 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010 3 NDC:0832-0511-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010 4 NDC:0832-0511-01 100 in 1 CARTON 01/24/2010 4 NDC:0832-0511-89 1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040634 01/24/2010

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0832-0512 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bethanechol Chloride (UNII: H4QBZ2LO84) (Bethanechol - UNII:004F72P8F4) Bethanechol Chloride 25 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) lactose monohydrate (UNII: EWQ57Q8I5X) magnesium stearate (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics Color YELLOW Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code BCL;25;832 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0832-0512-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010 2 NDC:0832-0512-25 250 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010 3 NDC:0832-0512-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010 4 NDC:0832-0512-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010 5 NDC:0832-0512-01 100 in 1 CARTON 01/24/2010 5 NDC:0832-0512-89 1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040635 01/24/2010

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0832-0513 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bethanechol Chloride (UNII: H4QBZ2LO84) (Bethanechol - UNII:004F72P8F4) Bethanechol Chloride 50 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) lactose monohydrate (UNII: EWQ57Q8I5X) magnesium stearate (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics Color YELLOW Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code BCL;50;832 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0832-0513-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010 2 NDC:0832-0513-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010 3 NDC:0832-0513-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010 4 NDC:0832-0513-01 100 in 1 CARTON 01/24/2010 4 NDC:0832-0513-89 1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040636 01/24/2010

Labeler - Upsher-Smith Laboratories, LLC (809088862)

Establishment
Name	Address	ID/FEI	Business Operations
Upsher-Smith Laboratories, LLC		809088862	MANUFACTURE(0832-0510, 0832-0511, 0832-0512, 0832-0513) , LABEL(0832-0510, 0832-0511, 0832-0512, 0832-0513) , PACK(0832-0510, 0832-0511, 0832-0512, 0832-0513)

Establishment
Name	Address	ID/FEI	Business Operations
Upsher-Smith Laboratories, LLC		047251004	ANALYSIS(0832-0510, 0832-0511, 0832-0512, 0832-0513)

Establishment
Name	Address	ID/FEI	Business Operations
Upsher-Smith Laboratories, LLC		079111820	LABEL(0832-0510, 0832-0511, 0832-0512, 0832-0513) , PACK(0832-0510, 0832-0511, 0832-0512, 0832-0513)

Revised: 11/2017 Document Id: 8813ae33-f2f0-4ffe-aa56-6bdb91247d73 34391-3 Set id: 80393410-dd51-4cac-b27c-50ece00cca37 Version: 6 Effective Time: 20171115 Upsher-Smith Laboratories, LLC

No Title 1572449690 ⮝

Full Prescribing Information

Indications & Usage  ⮝

Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

Dosage & Administration  ⮝

Dosage must be individualized, depending on the type and severity of the condition to be treated.

Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur.

The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour.

If necessary, the effects of the drug can be abolished promptly by atropine (see OVERDOSAGE).

Package Label.principal Display Panel  ⮝

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-7912(NDC:65162-573) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics Color YELLOW Score no score Shape ROUND Size 11mm Flavor Imprint Code AN;573 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0615-7912-39 30 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040855 11/21/2007

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL(0615-7912) , REPACK(0615-7912)

Revised: 9/2015 Document Id: fb7feddf-f05f-4544-9960-e9f70ee199c6 34391-3 Set id: 72dc1317-7419-4a69-9aa8-742c4de274ed Version: 2 Effective Time: 20150911 NCS HealthCare of KY, Inc dba Vangard Labs

No Title 1572449831 ⮝

Full Prescribing Information

Bethanechol Chloride 10mg Tablet ⮝

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-0846(NDC:65162-572) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code AN;572 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-0846-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2018 2 NDC:71335-0846-2 28 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2018 3 NDC:71335-0846-3 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2018

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040855 11/21/2007

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-0846) , RELABEL(71335-0846)

Revised: 9/2018 Document Id: 8746542f-6e10-4ba8-9d92-4ff67a98af39 34391-3 Set id: 76a04f69-f035-441e-b62c-3fd3c1a40c61 Version: 1 Effective Time: 20180908 Bryant Ranch Prepack

Description ⮝

Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine.

It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN2O2 and its structural formula is:

It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68.

Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: lactose monohydrate, silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and povidone.

Clinical Pharmacology ⮝

Bethanechol chloride acts principally by producing the effects of stimulation of the parasympathetic nervous system. It increases the tone of the detrusor urinae muscle, usually producing a contraction sufficiently strong to initiate micturition and empty the bladder. It stimulates gastric motility, increases gastric tone and often restores impaired rhythmic peristalsis.

Stimulation of the parasympathetic nervous system releases acetylcholine at the nerve endings. When spontaneous stimulation is reduced and therapeutic intervention is required, acetylcholine can be given, but it is rapidly hydrolyzed by cholinesterase and its effects are transient. Bethanechol chloride is not destroyed by cholinesterase and its effects are more prolonged than those of acetylcholine.

Effects on the GI and urinary tracts sometimes appear within 30 minutes after oral administration of bethanechol chloride, but more often 60 to 90 minutes are required to reach maximum effectiveness. Following oral administration, the usual duration of action of bethanechol is one hour, although large doses (300 to 400 mg) have been reported to produce effects for up to six hours. Subcutaneous injection produces a more intense action on bladder muscle than does administration of the drug.

Because of the selective action of bethanechol, nicotinic symptoms of cholinergic stimulation are usually absent or minimal when orally or subcutaneously administered in therapeutic doses, while muscarinic effects are prominent. Muscarinic effects usually occur within 5 to 15 minutes after subcutaneous injection, reach a maximum in 15 to 30 minutes, and disappear within two hours. Doses that stimulate micturition and defecation and increase peristalsis do not ordinarily stimulate ganglia or voluntary muscles. Therapeutic test doses in normal human subjects have little effect on heart rate, blood pressure or peripheral circulation.

Bethanechol chloride does not cross the blood-brain barrier because of its charged quaternary amine moiety. The metabolic rate and mode of excretion of the drug have not been elucidated.

A clinical study (Diokno, A.C.; Lapides, J.; Urol 10: 23-24, July 1977) was conducted on the relative effectiveness of oral and subcutaneous doses of bethanechol chloride on the stretch response of bladder muscle in patients with urinary retention. Results showed that 5 mg of the drug given subcutaneously stimulated a response that was more rapid in onset and of larger magnitude than an oral dose of 50 mg, 100 mg, or 200 mg. All the oral doses, however, had a longer duration of effect than the subcutaneous dose. Although the 50 mg oral dose caused little change in intravesical pressure in this study, this dose has been found in other studies to be clinically effective in the rehabilitation of patients with decompensated bladders.

Indications And Usage ⮝

Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

Contraindications ⮝

Hypersensitivity to bethanechol chloride tablets, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, epilepsy and parkinsonism.

Bethanechol chloride should not be employed when the strength or integrity of the gastrointestinal or bladder wall is in question, or in the presence of mechanical obstruction; when increased muscular activity of the gastrointestinal tract or urinary bladder might prove harmful, as following recent urinary bladder surgery, gastrointestinal resection and anastomosis, or when there is possible gastrointestinal obstruction; in bladder neck obstruction, spastic gastrointestinal disturbances, acute inflammatory lesions of the gastrointestinal tract, or peritonitis; or in marked vagotonia.

Precautions ⮝

General

In urinary retention, if the sphincter fails to relax as bethanechol contracts the bladder, urine may be forced up the ureter into the kidney pelvis. If there is bacteriuria, this may cause reflux infection.

Information for Patients

Bethanechol chloride tablets should preferably be taken one hour before or two hours after meals to avoid nausea or vomiting. Dizziness, lightheadedness or fainting may occur, especially when getting up from a lying or sitting position.

Drug Interactions

Special care is required if this drug is given to patients receiving ganglion blocking compounds because a critical fall in blood pressure may occur. Usually, severe abdominal symptoms appear before there is such a fall in the blood pressure.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of bethanechol chloride.

Pregnancy

Teratogenic effects: Pregnancy Category C

Animal reproduction studies have not been conducted with bethanechol chloride. It is also not known whether bethanechol chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bethanechol chloride should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions from bethanechol chloride in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions ⮝

Adverse reactions are rare following oral administration of bethanechol, but are more common following subcutaneous injection. Adverse reactions are more likely to occur when dosage is increased.

The following adverse reactions have been observed: Body as a Whole: malaise; Digestive: abdominal cramps or discomfort, colicky pain, nausea and belching, diarrhea, borborygmi, salivation; Renal: urinary urgency; Nervous System: headache; Cardiovascular: a fall in blood pressure with reflex tachycardia, vasomotor response; Skin: flushing producing a feeling of warmth, sensation of heat about the face, sweating; Respiratory: bronchial constriction, asthmatic attacks; Special Senses: lacrimation, miosis.

Causal Relationship Unknown: The following adverse reactions have been reported, and a causal relationship to therapy with bethanechol has not been established: Body as a Whole: malaise; Nervous System: seizures.

To report SUSPECTED ADVERSE REACTIONS, contact Heritage Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage ⮝

Early signs of overdosage are abdominal discomfort, salivation, flushing of the skin ("hot feeling"), sweating, nausea, and vomiting.

Atropine Sulfate is a specific antidote. The recommended dose for adults is 0.6 mg. Repeat doses can be given every two hours, according to clinical response. The recommended dosage in infants and children up to 12 years of age is 0.01 mg/kg (to a maximum single dose of 0.4 mg) repeated every two hours as needed until the desired effect is obtained or adverse effects of atropine preclude further usage. Subcutaneous injection of atropine is preferred except in emergencies when the intravenous route may be employed.

The oral LD50 of bethanechol chloride is 1510 mg/kg in the mouse.

Dosage And Administration ⮝

Dosage must be individualized, depending on the type and severity of the condition to be treated.

Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur.

The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour.

If necessary, the effects of the drug can be abolished promptly by atropine (see OVERDOSAGE).

How Supplied ⮝

Bethanechol Chloride Tablets USP

5 mg White, round, scored tablets in bottles of 100.

Debossed EP 118 on one side and plain on reverse side.

NDC 23155-676-01 Bottles of 100

10 mg White, round, scored tablets in bottles of 100.

Debossed EP 119 on one side and plain on reverse side.

NDC 23155-677-01 Bottles of 100

25 mg White, round, scored tablets in bottles of 100.

Debossed EP 120 on one side and plain on reverse side.

NDC 23155-678-01 Bottles of 100

50 mg - White, round, scored tablets in bottles of 100.

Debossed EP 121 on one side and plain on reverse side.

NDC 23155-679-01 Bottles of 100

Dispense in a tight container as defined in the USP.

Store at 20 -25 C (68 -77 F) [See USP Controlled Room Temperature].

Distributed by:

Heritage Pharmaceuticals Inc.

East Brunswick, NJ 08816

1.866.901.DRUG (3784)

51U000000298US02

Revised: 01/2019

Package Label.principal Display Panel 5 Mg ⮝

NDC 23155-676-01

Bethanechol Chloride Tablets, USP

5 mg

100 Tablets

Rx only

Package Label.principal Display Panel 10 Mg ⮝

NDC 23155-677-01

Bethanechol Chloride Tablets, USP

10 mg

100 Tablets

Rx only

Package Label.principal Display Panel 25 Mg ⮝

NDC 23155-678-01

Bethanechol Chloride Tablets, USP

25 mg

100 Tablets

Rx only

Package Label.principal Display Panel 50 Mg ⮝

NDC 23155-679-01

Bethanechol Chloride Tablets, USP

50 mg

100 Tablets

Rx only

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-676 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE (UNII: FZ989GH94E)

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code EP118 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23155-676-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091256 05/04/2010

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-677 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE (UNII: FZ989GH94E)

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code EP119 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23155-677-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091256 05/04/2010

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-678 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE (UNII: FZ989GH94E)

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code EP120 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23155-678-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2010

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091256 05/04/2010

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-679 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 50 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE (UNII: FZ989GH94E)

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code EP121 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23155-679-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091256 05/04/2010

Labeler - Heritage Pharmaceuticals Inc. (780779901)

Registrant - Heritage Pharma Labs, Inc (189630168)

Establishment
Name	Address	ID/FEI	Business Operations
Heritage Pharma Labs, Inc		189630168	ANALYSIS(23155-676, 23155-677, 23155-678, 23155-679) , LABEL(23155-676, 23155-677, 23155-678, 23155-679) , MANUFACTURE(23155-676, 23155-677, 23155-678, 23155-679) , PACK(23155-676, 23155-677, 23155-678, 23155-679)

Revised: 2/2019 Document Id: e46f8b96-9514-4085-92bf-52df4942eaf0 34391-3 Set id: 2a91b214-2e2c-4322-9fd4-7b8999174ce4 Version: 2 Effective Time: 20190212 Heritage Pharmaceuticals Inc.

Package Label.principal Display Panel ⮝

Bethanechol Chloride Tablets, 10 mg

100 Tablets

Rx only

NDC 64980-161-01

Each Tablet Contains:

Bethanechol Chloride, USP 10 mg

Usual Dosage: See package insert.

Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature]

WARNING: KEEP THIS AND ALL THE DRUGS OUT OF THE REACH OF CHILDREN

Dispense in a tight container as defined in the USP.

Manufactured for:

Rising Pharmaceuticals, Inc.

Allendale, NJ 07401

Manufactured by:

Heritage Pharma Labs Inc.

East Brunswick, New Jersey 08816, USA

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-160 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE (UNII: FZ989GH94E)

Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code EP118 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64980-160-01 100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091256 08/24/2010

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-161 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE (UNII: FZ989GH94E)

Product Characteristics Color WHITE Score no score Shape ROUND Size 8mm Flavor Imprint Code EP119 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64980-161-01 100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091256 04/06/2010

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-162 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE (UNII: FZ989GH94E)

Product Characteristics Color WHITE Score no score Shape ROUND Size 9mm Flavor Imprint Code EP120 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64980-162-01 100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091256 04/06/2010

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-163 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 50 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE (UNII: FZ989GH94E)

Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code EP121 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64980-163-01 100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091256 04/06/2010

Labeler - Rising Pharmaceuticals Inc. (041241766)

Registrant - Emcure Pharmaceuticals Limited (916921919)

Establishment
Name	Address	ID/FEI	Business Operations
Heritage Pharma Labs, Inc		189630168	analysis(64980-160, 64980-161, 64980-162, 64980-163) , label(64980-160, 64980-161, 64980-162, 64980-163) , manufacture(64980-160, 64980-161, 64980-162, 64980-163) , pack(64980-160, 64980-161, 64980-162, 64980-163)

Revised: 8/2015 Document Id: 0f85faea-c7b6-4ea2-a5b4-08fb5daa4fd8 34391-3 Set id: 591b6098-230b-4b38-be24-a3b273fabcca Version: 3 Effective Time: 20150813 Rising Pharmaceuticals Inc.

No Title 1572452466 ⮝

Bethanechol Chloride

Tablets, USP

Rx only

Description: ⮝

Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine.

It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N,-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN2O2 and its structural formula is:

It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68.

Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, talc, and magnesium stearate; the 50 mg tablet also contains D&C Yellow #10 aluminum lake.

Clinical Pharmacology: ⮝

Bethanechol chloride acts principally be producing the effects of stimulation of the parasympathetic nervous system. It increases the tone of the detrusor urinae muscle, usually producing a contraction sufficiently strong to initiate micturition and empty the bladder. It stimulates gastric motility, increases gastric tone and often restores impaired rhythmic peristalsis.

Stimulation of the parasympathetic nervous system releases acetylcholine at the nerve endings. When spontaneous stimulation is reduced and therapeutic intervention is required, acetylcholine can be given, but it is rapidly hydrolyzed by cholinesterase and its effects are transient. Bethanechol chloride is not destroyed by cholinesterase and its effects are more prolonged than those of acetylcholine.

Effects on the GI and urinary tracts sometimes appear within 30 minutes after oral administration of bethanechol chloride, but more often 60 to 90 minutes are required to reach maximum effectiveness. Following oral administration, the usual duration of action of bethanechol is one hour, although large doses (300 to 400 mg) have been reported to produce effects for up to six hours. Subcutaneous injection produces a more intense action on bladder muscle than does administration of the drug.

Because of the selective action of bethanechol, nicotinic symptoms of chlolinergic stimulation are usually absent or minimal when orally or subcutaneously administered in therapeutic doses, while muscarinic effects are prominent. Muscarinic effects usually occur within 5 to 15 minutes after subcutaneous injection, reach a maximum in 15 to 30 minutes, and disappear within two hours. Doses that stimulate micturition and defecation and increase peristalsis do not ordinarily stimulate ganglia or voluntary muscles. Therapeutic test doses in normal human subjects have little effect on heart rate, blood pressure or peripheral circulation.

Bethanechol chloride does not cross the blood-brain barrier because of its charged quaternary amine moiety. The metabolic rate and mode of excretion of the drug have not been elucidated.

A clinical study (Diokno, A.C.; Lapides, J.; Urol 10: 23-24, July 1977) was conducted on the relative effectiveness of oral and subcutaneous doses of bethanechol chloride on the stretch response of bladder muscle in patients with urinary retention. Results showed that 5 mg of the drug given subcutaneously stimulated a response that was more rapid in onset and of larger magnitude than an oral dose of 50 mg, 100 mg, or 200 mg. All the oral doses, however, had a longer duration of effect than the subcutaneous dose. Although the 50 mg oral dose caused little change in intravesical pressure in this study, this dose has been found in other studies to be clinically effective in the rehabilitation of patients with decompensated bladders.

Indications And Usage: ⮝

Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

Contraindications: ⮝

Hypersensitivity to bethanechol chloride tablets, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, epilepsy and parkinsonism.

Bethanechol chloride should not be employed when the strength or integrity of the gastrointestinal or bladder wall is in question, or in the presence of mechanical obstruction; when increased muscular activity of the gastrointestinal tract or urinary bladder might prove harmful, as following recent urinary bladder surgery, gastrointestinal resection and anastomosis, or when there is possible gastrointestinal obstruction; in bladder neck obstruction, spastic gastrointestinal disturbances, acute inflammatory lesions of the gastrointestinal tract, or peritonitis; or in marked vagotonia.

Precautions: ⮝

General:

In urinary retention, if the sphincter fails to relax as bethanechol contracts the bladder, urine may be forced up the ureter into the kidney pelvis. If there is bacteriuria, this may cause reflux infection.

Information for Patients:

Bethanechol chloride tablets should preferably be taken one hour before or two hours after meals to avoid nausea or vomiting. Dizziness, lightheadedness or fainting may occur, especially when getting up from a lying or sitting position.

Drug Interactions:

Special care is required if this drug is given to patients receiving ganglion blocking compounds because a critical fall in blood pressure may occur. Usually, severe abdominal symptoms appear there in such a fall in the blood pressure.

Carcinogeneis, Mutagenesis, Impairment of Fertility:

Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of bethanechol chloride.

Pregnancy: Teratogenic Effects:

Pregnancy Category C. Animal reproduction studies have not been conducted with bethanechol chloride. It is also not known whether bethanechol chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bethanechol chloride should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether this drug is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions from bethanechol chloride in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions: ⮝

Adverse reactions are rare following oral administration of bethanechol, but are more common following subcutaneous injection. Adverse reactions are more likely to occur when dosage is increased.

The following adverse reactions have been observed: Body as a Whole: malaise; Digestive: abdominal cramps or discomfort, colicky pain, nausea and belching, diarrhea, borborygmi, salivation; Renal: urinary urgency; Nervous System: headache; Cardiovascular: a fall in blood pressure with reflux tachycardia, vasomotor response; Skin: flushing producing a feeling of warmth, sensation of heat about the face, sweating; Respiratory: bronchial constriction, asthmatic attacks; Special Senses: lacrimation, miosis.

Causal Relationship Unknown: The following adverse reactions have been reported, and a causal relationship to therapy with bethanechol has not been established: Body as a whole: malaise; Nervous System: seizures.

Overdosage: ⮝

Early signs of overdosage are abdominal discomfort, salivation, flushing of the skin ( hot feeling ), sweating, nausea, and vomiting.

Atropine Sulfate is a specific antidote. The recommended dose for adults is 0.6 mg. Repeat doses can be given every two hours, according to clinical response. The recommended dosage in infants and children up to 12 years of age is 0.01 mg/kg (to a maximum single dose of 0.4 mg) repeated every two hours as needed until the desired effect is obtained or adverse effects of atropine preclude further usage. Subcutaneous injection of atropine is preferred except in emergencies when the intravenous route may be employed.

The oral LD50 of bethanechol chloride is 1510 mg/kg in the mouse.

Dosage And Administration: ⮝

Dosage must be individualized, depending on the type and severity of the condition to be treated.

Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur.

The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour.

If necessary, the effects of the drug can be abolished promptly by atropine (see OVERDOSAGE).

How Supplied: ⮝

Bethanechol Chloride Tablets are supplied as follows:

5 mg tablets: off-white, round, flat-faced beveled edge, bisected tablets debossed LCI over 1332 on one side and plain on the other side.

They are supplied in bottles of 100 tablets; NDC 10135-0515-01.

10 mg tablets: off-white, round, flat-faced beveled edge, bisected tablets debossed LCI over 1340 on one side and plain on the other side.

They are supplied in bottles of 100 tablets; NDC 10135-0516-01.

25 mg tablets: off-white, round, flat-faced beveled edge, bisected tablets debossed LCI over 1356 on one side and plain on the other side.

They are supplied in bottles of 100 tablets; NDC 10135-0517-01.

50 mg tablets: off-white, round, flat-faced beveled edge, bisected tablets debossed LCI over 1329 on one side and plain on the other side.

They are supplied in bottles of 100 tablets; NDC 10135-0518-01.

This container not intended for household use. Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP.

Store at 20 C to 25 C (68 F to 77 F); excursions permitted to 15 C to 30 C (59 F to 86 F). [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Manufactured by:

Lannett Company, Inc.

Philadelphia, PA 19136

RX Only

Made in the USA

Rev. 2 4/15 LAN

Principal Display Panel ⮝

Bethanechol Chloride Tablets, USP 25mg

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-2558(NDC:64679-967) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics Color YELLOW (light yellow) Score 2 pieces Shape OVAL (oval) Size 7mm Flavor Imprint Code W;967 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0615-2558-39 30 in 1 BLISTER PACK

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040533 09/29/2003

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-2557(NDC:64679-966) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics Color PINK Score 2 pieces Shape OVAL Size 7mm Flavor Imprint Code W;966 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0615-2557-39 30 in 1 BLISTER PACK

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040533 09/29/2003

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL(0615-2557, 0615-2558) , REPACK(0615-2557, 0615-2558)

Revised: 10/2012 Document Id: 048ea5dc-4eeb-4bce-8047-a0eade2ae885 34391-3 Set id: e9445fc1-8a27-4a93-8fe7-90ae5f2aaab7 Version: 3 Effective Time: 20121017 NCS HealthCare of KY, Inc dba Vangard Labs

Package/label Display Panel ⮝

Bethanechol Chloride Tablets USP 50 mg 100s Label Text

NDC 50111-326-01

Bethanechol
Chloride
Tablets, USP
50 mg

Rx only

100 TABLETS

TEVA

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-323 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code PLIVA;323 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50111-323-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/1990

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089095 09/30/1990

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-324 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code PLIVA;324 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50111-324-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/1990

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA088440 09/30/1990

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-325 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics Color YELLOW Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code PLIVA;325 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50111-325-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/1990

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA088441 09/30/1990

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-326 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 50 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics Color YELLOW Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code PLIVA;326 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50111-326-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/1990

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089096 09/30/1990

Labeler - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2017 Document Id: 87dc65d6-87e9-474f-a347-78359c062e54 34391-3 Set id: 80ee6156-18b8-45aa-9402-b40647173da8 Version: 6 Effective Time: 20171219 Teva Pharmaceuticals USA, Inc.

No Title 1572452649 ⮝

Full Prescribing Information

Packaging Information ⮝

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Amneal Pharmaceuticals LLC as follows:
(10 mg / 100 UD) NDC 68084-365-01 packaged from NDC 65162-572
(25 mg / 100 UD) NDC 68084-704-01 packaged from NDC 65162-573

Distributed by:
American Health Packaging
Columbus, OH 43217

8236501/0519F

Package/label Display Panel Carton 10 Mg ⮝

NDC 68084- 365-01

Bethanechol
Chloride Tablets, USP

10 mg

100 Tablets (10 10) Rx Only

Each Tablet Contains:
Bethanechol Chloride, USP..............................................10 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20 to 25 C (68 to 77 F); excursions permitted
between 15 to 30 C (59 to 86 F) [see USP Controlled Room
Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 65162-572, Amneal Pharmaceuticals LLC.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

036501
0236501/0519OS

Package/label Display Panel Blister 10 Mg ⮝

Bethanechol
Chloride
Tablet, USP

10 mg

Package/label Display Panel Carton 25 Mg ⮝

NDC 68084- 704-01

Bethanechol
Chloride Tablets, USP

25 mg

100 Tablets (10 10) Rx Only

Each Tablet Contains:
Bethanechol Chloride, USP............................................. 25 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20 to 25 C (68 to 77 F); excursions permitted
between 15 to 30 C (59 to 86 F) [see USP Controlled Room
Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 65162-573, Amneal Pharmaceuticals LLC.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

070401
0270401/0519OS

Package/label Display Panel Blister 25 Mg ⮝

Bethanechol
Chloride
Tablet, USP

25 mg

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-365(NDC:65162-572) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics Color white Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code AN;572 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68084-365-01 100 in 1 BOX, UNIT-DOSE 02/04/2015 1 NDC:68084-365-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040855 02/04/2015

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-704(NDC:65162-573) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics Color yellow Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code AN;573 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68084-704-01 100 in 1 BOX, UNIT-DOSE 02/05/2015 1 NDC:68084-704-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040855 02/05/2015

Labeler - American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Business Operations
American Health Packaging		929561009	repack(68084-365, 68084-704)

Revised: 6/2019 Document Id: 8af7f349-e52e-e126-e053-2995a90a8b7f 34391-3 Set id: ffb0b704-b574-434c-a052-bded5767e0bd Version: 5 Effective Time: 20190610 American Health Packaging

Description ⮝

Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine.

It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17ClN2O2 and its structural formula is:

It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68.

Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, talc, and magnesium stearate; the 50 mg tablet also contains D&C Yellow No. 10 aluminum lake.

Principal Display Panel 5 Mg Container Label ⮝

NDC 0527-1332-01

Bethanechol
Chloride
Tablets, USP

5 mg

Rx Only

100 TABLETS

Lannett

Principal Display Panel 10 Mg Container Label ⮝

NDC 0527-1340-01

Bethanechol
Chloride
Tablets, USP

10 mg

Rx Only

100 TABLETS

Lannett

Principal Display Panel 25 Mg Container Label ⮝

NDC 0527-1356-01

Bethanechol
Chloride
Tablets, USP

25 mg

Rx Only

100 TABLETS

Lannett

Principal Display Panel 50 Mg Container Label ⮝

NDC 0527-1329-01

Bethanechol
Chloride
Tablets, USP

50 mg

Rx Only

100 TABLETS

Lannett

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1332 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics Color WHITE (off-white) Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code LCI;1332 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0527-1332-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2008

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040703 03/27/2008

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1340 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics Color WHITE (off-white) Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code LCI;1340 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0527-1340-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2008

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040704 03/27/2008

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1356 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics Color WHITE (off-white) Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code LCI;1356 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0527-1356-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2008

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040678 03/27/2008

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1329 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 50 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics Color YELLOW Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code LCI;1329 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0527-1329-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2008

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040677 03/27/2008

Labeler - Lannett Company, Inc. (002277481)

Establishment
Name	Address	ID/FEI	Business Operations
Kremers Urban Pharmaceuticals Inc.		006422406	LABEL(0527-1332, 0527-1340, 0527-1356, 0527-1329) , PACK(0527-1332, 0527-1340, 0527-1356, 0527-1329)

Establishment
Name	Address	ID/FEI	Business Operations
Lannett Company, Inc.		002277481	MANUFACTURE(0527-1332, 0527-1340, 0527-1356, 0527-1329)

Establishment
Name	Address	ID/FEI	Business Operations
Lannett Company, Inc.		829757603	ANALYSIS(0527-1332, 0527-1340, 0527-1356, 0527-1329) , MANUFACTURE(0527-1332, 0527-1340, 0527-1356, 0527-1329)

Revised: 4/2017 Document Id: e612c3eb-e7f8-4aa8-babf-14bbe08794f8 34391-3 Set id: cb6a43e9-5663-47e1-8f77-ed4cb806436d Version: 9 Effective Time: 20170407 Lannett Company, Inc.

Product Informationbethanechol Chloride Tablets, Usp ⮝

Rx only

References ⮝

Manufactured by:

Wockhardt Limited

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Rev.050810

Package/label Display Panel  ⮝

Bethanechol Chloride Tablets, USP

25 mg

100 Tablets

BETHANECHOL CHLORIDE bethanechol chloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6178(NDC:65162-573) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics Color YELLOW Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code AN;573 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-6178-61 100 in 1 CARTON 04/01/2010 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040855 04/01/2010

Labeler - Major Pharmaceuticals (191427277)

Revised: 4/2019 Document Id: 2d0170ff-eb83-478c-9a1f-fa08d9d4c0c0 34391-3 Set id: c86f7dc5-7187-46c2-854f-a0876c510a96 Version: 6 Effective Time: 20190418 Major Pharmaceuticals