Label: BENZONATATE- benzonatate capsule
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 68382-247
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated June 18, 2019
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Benzonatate capsules, USP, 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.
Each benzonatate capsule for oral administration contains 100 mg or 200 mg of benzonatate. In addition, each capsule also contains the following inactive ingredients: gelatin, glycerin, noncrystallising sorbitol solution, methylparaben, propylparaben and purified water.Close
- CLINICAL PHARMACOLOGY
Benzonatate capsules act 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 capsules have no inhibitory effect on the respiratory center in recommended dosage.Close
- INDICATIONS AND USAGE
Benzonatate capsules are indicated for the symptomatic relief of cough.Close
Hypersensitivity to benzonatate or related compounds.Close
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.
Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate capsules in combination with other prescribed drugs.
Accidental Ingestion and Death in Children
Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate capsules 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).
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 capsules 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 to 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 capsules, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate capsules at one time.
Usage in Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with benzonatate capsules. It is also not known whether benzonatate capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate capsules should be given to a pregnant woman only if clearly needed.
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 capsules are administered to a nursing woman.
Carcinogenesis, mutagenesis, impairment of fertility
Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate capsules.
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 Capsules may include: Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.
Sedation; headache; dizziness; mental confusion; visual hallucinations.
Constipation; nausea; GI upset.
Pruritus; skin eruptions.
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.Close
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 to 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.
In case of overdose, seek 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 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 Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.Close
- HOW SUPPLIED
Benzonatate capsules USP, 100 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with "Z" containing pale yellow-colored clear viscous liquid and are supplied as follows:
NDC 68788-6357-9 in bottle of 9 capsules
NDC 68788-6357-5 in bottle of 15 capsules
NDC 68788-6357-2 in bottle of 20 capsules
NDC 68788-6357-3 in bottle of 30 capsules
NDC 68788-6357-6 in bottle of 60 capsules
Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container.Close
- SPL UNCLASSIFIED SECTION
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Cadila Healthcare Ltd.
Zydus Pharmaceuticals USA Inc.
Pennington, NJ 08534
Repackaged By: Preferred Pharmaceuticals Inc.Close
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Benzonatate Capsules USP, 100 mg
Repackaged By: Preferred Pharmaceuticals Inc.Close
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-6357(NDC:68382-247) 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 GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) Product Characteristics Color YELLOW (LIGHT YELLOW) Score no score Shape ROUND (ROUND) Size 3mm Flavor Imprint Code Z Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-6357-9 9 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2016 2 NDC:68788-6357-1 15 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2016 3 NDC:68788-6357-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2016 4 NDC:68788-6357-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2016 5 NDC:68788-6357-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040597 03/01/2016 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-6357)