Benzonatate - Benzonatate capsule prescribing information
INDICATIONS AND USAGE
Benzonatate Capsule 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 Capsules 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 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.
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.
Each Benzonatate Capsules USP contains: Benzonatate, USP 100 mg or 200 mg
Benzonatate Capsules USP also contain: D&C Yellow 10, gelatin, glycerin, methylparaben, propylparaben, shellac and titanium dioxide.
CLINICAL PHARMACOLOGY
Benzonatate Capsule 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 Capsule has no inhibitory effect on the respiratory center in recommended dosage.
HOW SUPPLIED
Benzonatate Capsules USP, 100 mg are available as yellow, oval soft gelatin capsules with'1'imprinted in white ink.
Bottles of 100 NDC 68094-798-50
Bottles of 500 NDC 68094-798-60
Benzonatate Capsules USP, 200 mg are available as yellow, oval soft gelatin capsules with'2'imprinted in white ink.
Bottles of 100 NDC 68094-901-50
Bottles of 500 NDC 68094-901-60
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].
PROTECT FROM LIGHT
