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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 

Label Image
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 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

100 mg Bottle Label

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

200 mg Bottle Label

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 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
100 Capsules

Package Label.principal Display Panel - 200 Mg 

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

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 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 

Benzonatate 100 mg Carton Label

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 

100 mg Benzonatate Capsule Blister

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 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 " 28"with white ink, quantity of 44,000 capsules (NDC 11788-028-00)

Benzonatate Capsules USP, 150 mg: Yellow soft gelatin capsules, imprinted " 29logo"with white ink, quantity of 32,000 capsules (NDC 11788-029-00)

Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted " 27"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.

structure

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

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 Aidarex Pharmaceuticals LLC

Benzonatate 200mg Capsule 

Label Image
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 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

ben 200

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 AiPing Pharmaceutical, Inc.

Benzonatate 200mg Capsule #500 

Label Image
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 Bryant Ranch Prepack



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