Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Benzonatate Capsules, USP are available as: 100 mg (oval, yellow) soft gelatin capsules with imprint “A1”. Bottles of 100: NDC 65162-536-10 Bottles of 500: NDC 65162-536-50 200 mg (oblong, yellow) soft gelatin capsules with imprint “A2”. Bottles of 100: NDC 65162-537-10 Bottles of 500: NDC 65162-537-50 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 09-2015-00; PRINCIPAL DISPLAY PANEL 1; PRINCIPAL DISPLAY PANEL 2
- HOW SUPPLIED Benzonatate Capsules, USP are available as: 100 mg (oval, yellow) soft gelatin capsules with imprint “A1”. Bottles of 100: NDC 65162-536-10 Bottles of 500: NDC 65162-536-50 200 mg (oblong, yellow) soft gelatin capsules with imprint “A2”. Bottles of 100: NDC 65162-537-10 Bottles of 500: NDC 65162-537-50 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 09-2015-00
- PRINCIPAL DISPLAY PANEL 1
- PRINCIPAL DISPLAY PANEL 2
Overview
Benzonatate, a non-narcotic 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. Benzonatate Capsules, USP contain 100 mg or 200 mg of benzonatate, USP. Benzonatate Capsules also contain: D&C Yellow No. 10, gelatin, glycerin, methylparaben sodium and propylparaben sodium. 66cb91e7-figure-01
Indications & Usage
Benzonatate is 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 should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.
Warnings & Precautions
No warnings available yet.
Boxed Warning
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 ).
Contraindications
Hypersensitivity to benzonatate or related compounds.
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.
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