Get your patient on Benzonatate - Benzonatate capsule (Benzonatate)

Benzonatate capsules is indicated for the symptomatic relief of cough.

Adults and Children over 10 years of age: Usual dose is one 100 mg, 150 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. B enzonatate capsules should be swallowed whole. Benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.

Hypersensitivity to benzonatate or related compounds.

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.

Der m atologic: 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.

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 USP contains:

Benzonatate, USP 100 mg

Each benzonatate capsule USP contains:

Benzonatate, USP 150 mg

Each benzonatate capsule USP contains:

Benzonatate, USP 200 mg

Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen.

100 mg and 200 mg capsules also contain D&C Yellow No. 10.

150 mg capsules also contain FD&C Yellow No. 6 powder.

Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink.

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

Benzonatate Capsules, USP are available in 100 mg, 150 mg and 200 mg dosage strengths.

The 100 mg capsules are yellow round capsules containing clear to light yellow liquid, printed with ‘1’ sign in black ink.

NDC 72865-117-30 bottles of 30 capsules

NDC 72865-117-01 bottles of 100 capsules

NDC 72865-117-05 bottles of 500 capsules

The 150 mg capsules are orange round capsules containing clear, light yellow to orange liquid, printed with ‘2’ sign in black ink.

NDC 72865-118-30 bottles of 30 capsules

NDC 72865-118-01 bottles of 100 capsules

NDC 72865-118-05 bottles of 500 capsules

The 200 mg capsules are yellow round capsules containing clear to light yellow liquid, printed with ‘3’ sign in black ink.

NDC 72865-119-30 bottles of 30 capsules

NDC 72865-119-01 bottles of 100 capsules

NDC 72865-119-05 bottles of 500 capsules

Store at 20°C to 25°C (68°F to77°F) [see USP Controlled Room Temperature].

Protect from light. Dispense in tight, light-resistant container as defined in the USP with a child-resistant closure.

Manufactured by:

Ascent Pharmaceuticals, Inc.

Central Islip, NY 11722

Manufactured for:

XLCare Pharmaceuticals, Inc.

242 South Culver Street, Suite 202

Lawrenceville, GA 30046

Rev: 01/22