BENZONATATE CAPSULES, USP Rx Only

Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan- 28-yl p-(butylamino) benzoate. The molecular formula is C₃₀H₅₃NO₁₁ with a molecular weight of 603.7

Each capsule, for oral administration, contains 100 mg or 200 mg of benzonatate, USP.

Benzonatate Capsules also contain: Alcohol, ammonium hydroxide, D&C Yellow 10, gelatin, glycerin, propylene glycol, purified water, shellac glaze, simethicone and titanium dioxide. In addition, the capsule may contain trace amounts of fractionated coconut oil.

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 capsules have no inhibitory effect on the respiratory center in recommended dosage.

Benzonatate capsules 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.

Psychiatric Effects

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

Accidental Ingestion and Death in Children

Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate capsules resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE).

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 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.

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.

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.

Benzonatate capsules, USP 100 mg are clear, yellow liquid filled in oval-shaped softgel capsule, imprinted “133” in white ink. The capsules are available as:

NDC 57664-133-88       Bottles of 100      CRC

NDC 57664-133-13       Bottles of 500

Benzonatate capsules, USP 200 mg are clear, yellow liquid filled in oval-shaped softgel capsule, imprinted “134” in white ink. The capsules are available as:

NDC 57664-134-88       Bottles of 100      CRC

NDC 57664-134-13       Bottles of 500

Store at 20° - 25°C (68° - 77°F). (See USP Controlled Room Temperature).

PROTECT FROM LIGHT.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP TIGHTLY CLOSED.

Distributed by:Sun Pharmaceutical Industries,Inc.
                         Cranbury, NJ 08512

6351T04
Rev. 08/2014

NDC 57664-133-88

Benzonanate Capsules, USP

100 mg

Rx only

100 Capsules
benzonatate-10

NDC 57664-134-88

Benzonanate Capsules, USP

200 mg

Rx only

100 Capsules