BENZONATATE - Strides Pharma Science Limited | Onesource Specialty Pte. Limited

Benzonatate capsules USP 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.

Structure

Each benzonatate capsule USP, 100 mg contains:

Benzonatate USP 100 mg

Each benzonatate capsule USP, 200 mg contains:
Benzonatate USP 200 mg

Benzonatate capsules USP also contain: D&C Yellow 10, gelatin, glycerin, methylparaben, propylparaben and purified water.
Ingredients of the imprinting ink are: Propylene glycol, shellac resins, sodium lauryl sulphate, isopropyl alcohol 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.

Hypersensitivity

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.

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

Potential Adverse Reactions to benzonatate may include:

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.

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 USP should be swallowed whole. Benzonatate capsules USP are not to be broken, chewed, dissolved, cut or crushed.

Benzonatate capsules USP, 100 mgare available as yellow colored, oval shaped soft gelatin capsules, imprinted as '705' in white ink and containing clear, pale yellow viscous liquid.

NDC 64380-712-06 in bottles of 100 capsules.
NDC 64380-712-07 in bottles of 500 capsules.

Benzonatate capsules USP, 200 mgare available as yellow colored, oval shaped soft gelatin capsules, imprinted as ‘704’ in white ink and containing clear, pale yellow viscous liquid.
NDC 64380-713-06 in bottles of 100 capsules.
NDC 64380-713-07 in bottles of 500 capsules.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]

Protect Form Light.Dispense in a tight (USP), child-resistant containers.

Distributed by:
Strides Pharma, Inc.
Bridgewater, NJ 08807
Rx Only
Revised: 06/2026

NDC 64380-712-06
Benzonatate Capsules USP
100mg
PROTECT FROM LIGHT
Strides Pharma, Inc.
100 Capsules
RX only

Benzonatate-100mg-100cap

NDC 64380-712-07

Benzonatate Capsules USP

100mg

PROTECT FROM LIGHT

Strides Pharma, Inc.

500 Capsules

RX only

Benzonatate-100mg-500cap

NDC 64380-713-06
Benzonatate Capsules USP
200mg
PROTECT FROM LIGHT
Strides Pharma, Inc.
100 Capsules
RX only

Benzonatate-200mg-100cap

NDC 64380-713-07
Benzonatate Capsules USP
200mg
PROTECT FROM LIGHT
Strides Pharma, Inc.
500 Capsules
RX only

Benzonatate-200mg-500cap.jpg