Benzonatate - Benzonatate capsule prescribing information
INDICATIONS AND USAGE
Benzonatate capsules, USP are 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.
Hypersensitivity reactions
including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.
DESCRIPTION
Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. 
Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink.
CLINICAL PHARMACOLOGY
Benzonatate capsules act 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 capsules have no inhibitory effect on the respiratory center in recommended dosage.
HOW SUPPLIED
Benzonatate Capsules USP, 100 mg are clear yellow, oval-shaped softgel capsules imprinted with “PC14” and are supplied as follows:
NDC 42806-714-01 in bottle of 100 capsules
NDC 42806-714-05 in bottle of 500 capsules
Benzonatate Capsules USP, 200 mg are clear yellow, oval-shaped softgel capsules imprinted with “PC15” and are supplied as follows:
NDC 42806-715-01 in bottle of 100 capsules
NDC 42806-715-05 in bottle of 500 capsules
Store at 20˚ to 25˚ C (68˚ to 77˚ F) [see USP Controlled Room Temperature].
PROTECT FROM LIGHT
Dispense in tight (USP), child-resistant containers.
Rx Only
Manufactured by:
Humanwell PuraCap Pharmaceutical
Wuhan, Hubei 430206, China
Distributed by:
Epic Pharma, LLC
Laurelton, NY 11413
Rev. 10-2018-00
PI-EBEN-00
