Benzonatate - Benzonatate capsule, Liquid Filled prescribing information
INDICATIONS AND USAGE
Benzonatate is indicated for the symptomatic relief of cough.
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 should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.
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.
DESCRIPTION
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.
CLINICAL PHARMACOLOGY
Benzonatate acts 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 has no inhibitory effect on the respiratory center in recommended dosage.
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
