BENZONATATE capsule

1. No Title 1572548134
2. No Title 1572550921
3. No Title 1572555019
4. Benzonatate
5. Benzonatate Capsules Usp, 100 Mg And 200 Mg
6. Principal Display Panel - 100 Mg Capsule Bottle Label
7. Principal Display Panel - 200 Mg Capsule Bottle Label
8. Indications And Usage
9. Boxed Warning
10. Dosage And Administration
11. Package Label.principal Display Panel - 100 Mg
12. Package Label.principal Display Panel - 200 Mg
13. Storage
14. Packaging Information
15. Package/label Display Panel Carton 100 Mg
16. Package/label Display Panel Blister 100 Mg
17. No Title 1572452934
18. Clinical Pharmacology
19. Indications And Usage
20. Contraindications
21. Warnings
22. Precautions
23. Usage In Pregnancy
24. Adverse Reactions
25. Overdosage
26. Dosage And Administration
27. How Supplied
28. Description
29. Principal Display Panel
30. Benzonatate 200mg Capsule
31. No Title 1572457514
32. No Title 1572457515
33. No Title 1572457612
34. Principal Display Panel - Shipping Label
35. Benzonatate 200mg Capsule #500

No Title 1572548134 ⮝

Pediatric Use
Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

No Title 1572550921 ⮝

Pediatric Use

Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

No Title 1572555019 ⮝

Pediatric Use
Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

Benzonatate ⮝

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3212(NDC:67877-573) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 100 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) glycerin (UNII: PDC6A3C0OX) water (UNII: 059QF0KO0R) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics Color yellow Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 105 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-3212-0 15 in 1 BOTTLE; Type 0: Not a Combination Product 10/26/2017

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040627 03/22/2017

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3246(NDC:67877-575) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 200 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) glycerin (UNII: PDC6A3C0OX) water (UNII: 059QF0KO0R) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics Color yellow Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 106 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-3246-0 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/06/2017 2 NDC:50090-3246-1 45 in 1 BOTTLE; Type 0: Not a Combination Product 11/06/2017 3 NDC:50090-3246-2 15 in 1 BOTTLE; Type 0: Not a Combination Product 04/16/2018

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040749 03/22/2017

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-3246, 50090-3212) , REPACK(50090-3212, 50090-3246)

Revised: 8/2018 Document Id: e457afc7-23fc-4026-b5ae-1432a343b796 34391-3 Set id: f5e1f3e6-0f04-4e37-bcab-f068922df01a Version: 6 Effective Time: 20180831 A-S Medication Solutions

Benzonatate Capsules Usp, 100 Mg And 200 Mg ⮝

Rx only

Principal Display Panel - 100 Mg Capsule Bottle Label ⮝

BIONPHARMA

NDC 69452-143-20

Benzonatate Capsules, USP

100 mg

Protect from Light

Rx only

100 Soft Gelatin Capsules

Principal Display Panel - 200 Mg Capsule Bottle Label ⮝

BIONPHARMA

NDC 69452-144-20

Benzonatate Capsules, USP

200 mg

Protect from Light

Rx only

100 Soft Gelatin Capsules

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-143 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzonatate (UNII: 5P4DHS6ENR) (Benzonatate - UNII:5P4DHS6ENR) Benzonatate 100 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R)

Product Characteristics Color YELLOW Score no score Shape OVAL (CAPSULE) Size 9mm Flavor Imprint Code PA46 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69452-143-20 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/15/2016 2 NDC:69452-143-30 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/15/2016

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA081297 08/15/2016

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-144 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzonatate (UNII: 5P4DHS6ENR) (Benzonatate - UNII:5P4DHS6ENR) Benzonatate 200 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R)

Product Characteristics Color YELLOW Score no score Shape OVAL (CAPSULE) Size 9mm Flavor Imprint Code PA83 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69452-144-20 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/15/2016 2 NDC:69452-144-30 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/15/2016

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA081297 08/15/2016

Labeler - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
Patheon Softgels Inc.		002193829	MANUFACTURE(69452-143, 69452-144)

Revised: 3/2018 Document Id: 94574453-dddf-40e0-99ac-f5655d7a9e39 34391-3 Set id: 2630be01-1d2d-4c40-8e56-8568ea89eacf Version: 3 Effective Time: 20180321 Bionpharma Inc.

Indications And Usage ⮝

Benzonatate is indicated for the symptomatic relief of cough.

Boxed Warning ⮝

Hypersensitivity

Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.

Psychiatric Effects

Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate in combination with other prescribed drugs.

Accidental Ingestion and Death in Children

Keep benzonatate out of reach of children.

Accidental ingestion of benzonatate resulting in death has been reported in children below age 10.

Signs and symptoms of overdose have been reported within 15 to 20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE).

Dosage And Administration ⮝

Adults and Children over 10 years of age:

Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.

Package Label.principal Display Panel - 100 Mg ⮝

NDC 62332-426-31
Benzonatate
Capsules, USP
100 mg
Rx only
100 Capsules
Alembic

Package Label.principal Display Panel - 200 Mg ⮝

NDC 62332-427-31
Benzonatate
Capsules, USP
200 mg
Rx only
100 Capsules
Alembic

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-426 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 100 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)

Product Characteristics Color YELLOW Score no score Shape OVAL Size 9mm Flavor Imprint Code A5 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62332-426-31 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018 2 NDC:62332-426-71 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040682 05/01/2018

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-427 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 200 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)

Product Characteristics Color YELLOW Score no score Shape CAPSULE Size 16mm Flavor Imprint Code A6 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62332-427-31 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018 2 NDC:62332-427-71 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040682 05/01/2018

Labeler - Alembic Pharmaceuticals Inc. (079288842)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss Caps AG		481784895	MANUFACTURE(62332-426, 62332-427)

Revised: 10/2019 Document Id: 7186c55f-a9f8-4760-9396-8dbe1c747197 34391-3 Set id: c2d5bbc3-40a3-4b2f-9bc5-276acf21aa3e Version: 3 Effective Time: 20191009 Alembic Pharmaceuticals Inc.

Storage ⮝

Store at 20 to 25 C (68 to 77 F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Manufactured by Intergel Division of IVC Industries, Inc. Irvington, NJ 07111

Packaging Information  ⮝

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Ascend Laboratories, LLC as follows:
(100 mg / 100 UD) NDC 60687-346-01 packaged from NDC 67877-573

Distributed by:
American Health Packaging
Columbus, OH 43217

8434601/1117F

Package/label Display Panel Carton 100 Mg ⮝

NDC 60687- 346-01

Benzonatate
Capsules, USP

100 mg

100 Capsules (10 x 10) Rx Only

Each Soft Gelatin Capsule Contains:
Benzonatate, USP...................................................................100 mg

Usual Dosage: See package insert for full prescribing information.

Information for Patients: Swallow benzonatate capsules whole.
Do not break, chew, dissolve, cut, or crush benzonatate capsules
USP.

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].

PROTECT FROM LIGHT.

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 # 67877-573, Ascend Laboratories, LLC.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

734601
0434601/0119OS

Package/label Display Panel Blister 100 Mg ⮝

Benzonatate
Capsule, USP
100 mg

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-346(NDC:67877-573) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 100 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics Color yellow Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 105 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60687-346-01 100 in 1 BOX, UNIT-DOSE 12/07/2017 1 NDC:60687-346-11 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 ANDA040627 12/07/2017

Labeler - American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Business Operations
American Health Packaging		929561009	repack(60687-346)

Revised: 2/2019 Document Id: 8231c1e4-5e35-5834-e053-2991aa0a0b16 34391-3 Set id: 77d21dea-440b-4453-b965-13c9c504f420 Version: 2 Effective Time: 20190218 American Health Packaging

No Title 1572452934 ⮝

Information for Patients Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut, or crush Benzonatate Capsules. Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of foods or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.

Keep benzonatate out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately. Overdosage resulting in death may occur in adults. Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of benzonatate capsule, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate at one time.

Clinical Pharmacology ⮝

Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. Benzonatate has no inhibitory effect on the respiratory center in recommended dosage.

Indications And Usage ⮝

Benzonatate USP is indicated for the symptomatic relief of cough.

Contraindications ⮝

Hypersensitivity to benzonatate or related compounds.

Warnings ⮝

Hypersensitivity

Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.

Psychiatric Efects

Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate in combination with other prescribed drugs.

Accidental Ingestion and Death in Children

Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE).

Precautions ⮝

Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g. procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.

Information for Patients Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut, or crush Benzonatate Capsules. Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.

Keep benzonatate out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately.

Overdosage resulting in death may occur in adults.

Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of benzonatate capsule, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate at one time.

Usage In Pregnancy ⮝

PREGNANCY CATEGORY C

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

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when benzonatate is administered to a nursing woman.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate.

Pediatric Use

Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

Adverse Reactions ⮝

Potential Adverse Reactions to benzonatate may include:

Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.

CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.

GI: constipation; nausea; GI upset.

Dermatologic: pruritus; skin eruptions.

Other: nasal congestion; sensation of burning in the eyes; vague chilly sensation; numbness of the chest; hypersensitivity. Deliberate or accidental overdose has resulted in death, particularly in children.

Overdosage ⮝

Intentional and unintentional overdose may result in death, particularly in children. The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.

Signs and Symptoms

The signs and symptoms of overdose of benzonatate have been reported within 15-20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise. CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion.

Treatment

In case of overdose, seek medical attention immediately. Evacuate gastric contents and administer copious amounts of activated charcoal slurry. Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage. Do not use CNS stimulants.

Dosage And Administration ⮝

Adults and Children over 10 years of age: Usual dose is one 100 mg, 150 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate should be swallowed whole. Benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.

How Supplied ⮝

Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted " "with white ink, quantity of 44,000 capsules (NDC 11788-028-00)

Benzonatate Capsules USP, 150 mg: Yellow soft gelatin capsules, imprinted " "with white ink, quantity of 32,000 capsules (NDC 11788-029-00)

Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted " "with white ink, quantity of 24,000 capsules (NDC 11788-027-00)

Store at room temperature 15-30 C

Manufacturer:

Anishi Pharmaceutical (Zhongshan) Inc.

National Health Technology Park, Zhongshan, Guangdong. China

For:

AiPing Pharmaceutical, Inc.

Hauppauge, NY 11788 USA

Description ⮝

Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7.

C 30H 53NO 11

Each soft gelatin capsule, for oral administration, contains 100 mg, 150 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, purified water, methylparaben and propylparaben. Imprinting ink is composed of isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac, and titanium dioxide.

Principal Display Panel ⮝

Repackaged by:
Aidarex Pharmaceuticals, LLC
Corona, CA 92880

NDC 53217-0338

ASCEND
Laboratories, LLC

Benzonatate
Capsules, USP

200 mg

Rx only

53217-0338_BENZONATATE_200mg

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-338(NDC:67877-575) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 200 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics Color YELLOW Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 106 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53217-338-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/20/2017

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040749 11/20/2017

Labeler - Aidarex Pharmaceuticals LLC (801503249)

Revised: 8/2018 Document Id: 3e9d52e5-8e9f-4e8d-bc60-b6712f8744a1 34391-3 Set id: 1fda0d89-1c46-4411-9565-9546995998db Version: 1 Effective Time: 20180814 Aidarex Pharmaceuticals LLC

Benzonatate 200mg Capsule ⮝

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-0031(NDC:51224-001) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 200 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics Color yellow Score no score Shape OVAL Size 11mm Flavor Imprint Code N01 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-0031-5 15 in 1 BOTTLE; Type 0: Not a Combination Product 07/18/2017 2 NDC:71335-0031-8 50 in 1 BOTTLE; Type 0: Not a Combination Product 07/18/2017 3 NDC:71335-0031-2 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/18/2017 4 NDC:71335-0031-3 45 in 1 BOTTLE; Type 0: Not a Combination Product 07/18/2017 5 NDC:71335-0031-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/18/2017 6 NDC:71335-0031-6 21 in 1 BOTTLE; Type 0: Not a Combination Product 07/18/2017 7 NDC:71335-0031-7 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/18/2017 8 NDC:71335-0031-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/18/2017 9 NDC:71335-0031-4 20 in 1 BOTTLE; Type 0: Not a Combination Product 07/18/2017

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202765 08/10/2015

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-0031) , RELABEL(71335-0031)

Revised: 12/2017 Document Id: b81aecb5-f674-4ce9-8d16-0daf4101b568 34391-3 Set id: 6c5f67b0-3788-44e7-8dce-bcd58883d4a0 Version: 1 Effective Time: 20171228 Bryant Ranch Prepack

No Title 1572457514 ⮝

Information for Patients Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut, or crush Benzonatate Capsules. Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of foods or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.

Keep benzonatate out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately. Overdosage resulting in death may occur in adults. Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of benzonatate capsule, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate at one time.

No Title 1572457515 ⮝

Pediatric Use
Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

No Title 1572457612 ⮝

Information for Patients

Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut, or crush Benzonatate Capsules. Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of foods or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.

Keep benzonatate out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately. Overdosage resulting in death may occur in adults. Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of benzonatate capsule, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate at one time.

Principal Display Panel - Shipping Label ⮝

Manufactured for:

AiPing Pharmaceutical, Inc.

Hauppauge, NY 11788, USA

Manufactured by:

Anshi Pharamceutical (Zhongshan) Inc.

National Health Technology Park

Zhongshan, Guangdong, China

WARNING:

KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.

Benzonatate Capsules, USP 200mg

Quantity: 8 Kg/Case

NDC 11788-027-00

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11788-028 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 100 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics Color yellow Score no score Shape CAPSULE Size 9mm Flavor Imprint Code Logo;28 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11788-028-00 44000 in 1 CARTON; Type 0: Not a Combination Product 03/14/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210562 03/14/2019

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11788-029 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 150 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics Color yellow Score no score Shape CAPSULE Size 10mm Flavor Imprint Code Logo;29 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11788-029-00 32000 in 1 CARTON; Type 0: Not a Combination Product 03/14/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210562 03/14/2019

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11788-027 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 200 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics Color yellow Score no score Shape CAPSULE Size 11mm Flavor Imprint Code Logo;27 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11788-027-00 24000 in 1 CARTON; Type 0: Not a Combination Product 03/14/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210562 03/14/2019

Labeler - AiPing Pharmaceutical, Inc. (079674526)

Establishment
Name	Address	ID/FEI	Business Operations
Anshi Pharmaceutical (Zhongshan) Inc.		528101821	manufacture(11788-028, 11788-029, 11788-027)

Revised: 10/2019 Document Id: 93db2bcb-be58-a2df-e053-2a95a90a4ca4 34391-3 Set id: 7c210c0e-72b8-9656-e053-2991aa0a9455 Version: 2 Effective Time: 20191001 AiPing Pharmaceutical, Inc.

Benzonatate 200mg Capsule #500 ⮝

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-1051(NDC:67877-573) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 100 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) glycerin (UNII: PDC6A3C0OX) water (UNII: 059QF0KO0R) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics Color yellow Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 105 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-1051-1 1 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2017

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040627 03/22/2017

BENZONATATE benzonatate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-1053(NDC:67877-575) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 200 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) glycerin (UNII: PDC6A3C0OX) water (UNII: 059QF0KO0R) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics Color yellow Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 106 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-1053-1 1 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2017

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040749 03/22/2017

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(63629-1053, 63629-1051) , RELABEL(63629-1051, 63629-1053)

Revised: 9/2019 Document Id: a75b893d-842f-481d-a66c-fc5b899fea54 34391-3 Set id: ca43921d-d1f5-4ac3-b9d6-f683a0d3e182 Version: 2 Effective Time: 20190911 Bryant Ranch Prepack