Benzonatate 200 mg

INDICATIONS & USAGE Benzonatate capsules are 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 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 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 Capsule contains Benzonatate, USP 100 mg or 200 mg Benzonatate Capsules USP also contain: gelatin, glycerin, purified water, sorbitol sorbitan solution. The imprinting ink contains propylene glycol, shellac and titanium dioxide. FDA approved dissolution test specifications differ from USP. benzonatate-capsules-description

OVERDOSAGE Intentional and unintentional overdose may result in death, particularly in children. 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. Signs and Symptoms: The signs and symptoms of overdose of benzonatate have been reported within 15-20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise. CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion. Treatment: In case of overdose, seek medical attention immediately. Evacuate gastric contents and administer copious amounts of activated charcoal slurry. Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage. Do not use CNS stimulants.

HOW SUPPLIED Benzonatate Capsules USP, 100 mg (Light yellow to yellow coloured, transparent to translucent, oval shaped capsule imprinted with '132' in white colour on capsule shell) Bottle of 30 NDC 25000-002-03 Benzonatate Capsules USP, 100 mg (Light yellow to yellow coloured, transparent to translucent, oval shaped capsule imprinted with '132' in white colour on capsule shell) Bottle of 100 NDC 25000-002-08 Benzonatate Capsules USP, 100 mg (Light yellow to yellow coloured, transparent to translucent, oval shaped capsule imprinted with '132' in white colour on capsule shell) Bottle of 500 NDC 25000-002-12 Benzonatate Capsules USP, 200 mg (Light yellow to yellow coloured, transparent to translucent, oval shaped capsule imprinted with '137' in white colour on capsule shell) Bottle of 30 NDC 25000-003-03 Benzonatate Capsules USP, 200 mg (Light yellow to yellow coloured, transparent to translucent, oval shaped capsule imprinted with '137' in white colour on capsule shell) Bottle of 100 NDC 25000-003-08 Benzonatate Capsules USP, 200 mg (Light yellow to yellow coloured, transparent to translucent, oval shaped capsule imprinted with '137' in white colour on capsule shell) Bottle of 500 NDC 25000-003-12 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. To report SUSPECTED ADVERSE REACTIONS, contact Marksans Pharma Ltd. at 1-877-290-4008 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa-403722, India Rev. 03/26