Drug Facts
Composition & Profile
Identifiers & Packaging
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: Unit dose packages of 100 (10 x 10) NDC 68084-214-01 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] FOR YOUR PROTECTION: Do not use if blister is torn or broken. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.; Package/Label Display Panel – Carton – 100 mg NDC 68084- 214 -01 Benzonatate Capsules, USP 100 mg 100 Capsules (10 x 10) Rx Only Each Capsule Contains: Benzonatate, USP …………………………………. 10 mg Usual Dosage: See 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 68382-247, Zydus Pharmaceuticals (USA) Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 801054 0224101/0924 100 mg Benzonatate Capsules Carton; Package/Label Display Panel – Blister – 100 mg Benzonatate Capsule, USP 100 mg 100 mg Benzonatate Capsule Blister
- 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: Unit dose packages of 100 (10 x 10) NDC 68084-214-01 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] FOR YOUR PROTECTION: Do not use if blister is torn or broken. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
- Package/Label Display Panel – Carton – 100 mg NDC 68084- 214 -01 Benzonatate Capsules, USP 100 mg 100 Capsules (10 x 10) Rx Only Each Capsule Contains: Benzonatate, USP …………………………………. 10 mg Usual Dosage: See 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 68382-247, Zydus Pharmaceuticals (USA) Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 801054 0224101/0924 100 mg Benzonatate Capsules Carton
- Package/Label Display Panel – Blister – 100 mg Benzonatate Capsule, USP 100 mg 100 mg Benzonatate Capsule Blister
Overview
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. Structural Formula
Indications & Usage
Benzonatate capsules are indicated for the symptomatic relief of cough.
Dosage & 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.
Warnings & Precautions
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 Effects 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 ).
Contraindications
Hypersensitivity to benzonatate or related compounds.
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. 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.
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