Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Benzonatate Capsules, USP are available as: 100 mg Oval Shape, imprint “100” with white ink, transparent yellow soft gelatin capsule NDC 23155-898-01 Bottles of 100 NDC 23155-898-05 Bottles of 500 200 mg Oblong Shape, imprint “200” with white ink, transparent yellow soft gelatin capsules NDC 23155-899-01 Bottles of 100 NDC 23155-899-05 Bottles of 500 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: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000461US01 Revised: 04/2024 image description; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 100 mg NDC 23155- 898 -01 Benzonatate Capsules, USP 100 mg 100 Capsules Rx only label-100mg-100s-rev042024; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 200 mg NDC 23155- 899 -01 Benzonatate Capsules, USP 200 mg 100 Capsules Rx only label-200mg-100s-rev042024
- HOW SUPPLIED Benzonatate Capsules, USP are available as: 100 mg Oval Shape, imprint “100” with white ink, transparent yellow soft gelatin capsule NDC 23155-898-01 Bottles of 100 NDC 23155-898-05 Bottles of 500 200 mg Oblong Shape, imprint “200” with white ink, transparent yellow soft gelatin capsules NDC 23155-899-01 Bottles of 100 NDC 23155-899-05 Bottles of 500 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: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000461US01 Revised: 04/2024 image description
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 100 mg NDC 23155- 898 -01 Benzonatate Capsules, USP 100 mg 100 Capsules Rx only label-100mg-100s-rev042024
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 200 mg NDC 23155- 899 -01 Benzonatate Capsules, USP 200 mg 100 Capsules Rx only label-200mg-100s-rev042024
Overview
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. 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. The white imprinting ink contains the following inactive ingredients: ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze, simethicone and titanium dioxide. FDA approved dissolution test specifications differ from USP. structure
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
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 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. To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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