Benzonatate - ETHEX Corporation

Rx Only

P5519-1 01/08

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 capsule contains benzonatate, USP, 100 mg or 200 mg.

Benzonatate capsules, USP also contain gelatin, glycerin, methyl/propyl paraben blend, purified water, and titanium dioxide.

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.

Benzonatate capsules, USP are indicated for the symptomatic relief of cough.

Hypersensitivity to benzonatate or related compounds.

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.

Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate capsules, USP in combination with other prescribed drugs.

Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g., procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.

Potential adverse reactions to benzonatate capsules, USP may include:

Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.

Overdose may result in death.

The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.

Adults and children over 10: Usual dose is one 100 mg or 200 mg capsule t.i.d. as required. If necessary, up to 600 mg daily may be given.

Benzonatate capsules, USP 100 mg are round, white soft gelatin capsules, imprinted in black ink “E,” packaged as follows:

NDC 58177-091-04 bottle of 100 capsules

NDC 58177-091-08 bottle of 500 capsules

NDC 58177-091-11 unit dose package of 100 capsules (10 capsules per blister card)

Benzonatate capsules, USP 200 mg are oval, white soft gelatin capsules, imprinted in black ink “E2,” packaged as follows:

NDC 58177-092-04 bottle of 100 capsules

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Protect from light.

Dispense in a tight, light resistant container as defined in the USP.

Manufactured by
AccuCaps
Windsor, Ontario, Canada
for
ETHEX Corporation
St. Louis, MO 63044 USA

P5519-1 01/08