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: NDC 68382-247-01 in bottle of 100 capsules NDC 68382-247-05 in bottle of 500 capsules Benzonatate capsules USP, 200 mg are light yellow-colored, oval-shaped soft gelatin capsules, imprinted with "β" containing pale yellow-colored clear viscous liquid and are supplied as follows: NDC 68382-091-01 in bottle of 100 capsules Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68382-247-01 in bottle of 100 capsules Benzonatate Capsules USP, 100 mg R x only 100 capsules ZYDUS NDC 68382-091-01 in bottle of 100 capsules Benzonatate Capsules USP, 200 mg R x only 100 capsules ZYDUS Structured formula for Benzonatate Capsules Structured formula for Benzonatate Capsules
- 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 68382-247-01 in bottle of 100 capsules NDC 68382-247-05 in bottle of 500 capsules Benzonatate capsules USP, 200 mg are light yellow-colored, oval-shaped soft gelatin capsules, imprinted with "β" containing pale yellow-colored clear viscous liquid and are supplied as follows: NDC 68382-091-01 in bottle of 100 capsules Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68382-247-01 in bottle of 100 capsules Benzonatate Capsules USP, 100 mg R x only 100 capsules ZYDUS NDC 68382-091-01 in bottle of 100 capsules Benzonatate Capsules USP, 200 mg R x only 100 capsules ZYDUS Structured formula for Benzonatate Capsules Structured formula for Benzonatate Capsules
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. Structure forluma for Benzonatate
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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