Drug Facts
Composition & Profile
Identifiers & Packaging
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 31722-956-30 bottles of 30 capsules NDC 31722-956-01 bottles of 100 capsules NDC 31722-956-05 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 31722-957-30 bottles of 30 capsules NDC 31722-957-01 bottles of 100 capsules NDC 31722-957-05 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 72189-606-30 bottles of 30 capsules NDC 72189-606-30 bottles of 100 capsules NDC 72189-606-30 bottles of 500 capsules; 72189-606-30
- 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 31722-956-30 bottles of 30 capsules NDC 31722-956-01 bottles of 100 capsules NDC 31722-956-05 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 31722-957-30 bottles of 30 capsules NDC 31722-957-01 bottles of 100 capsules NDC 31722-957-05 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 72189-606-30 bottles of 30 capsules NDC 72189-606-30 bottles of 100 capsules NDC 72189-606-30 bottles of 500 capsules
- 72189-606-30
Overview
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. [benzonatate-struct] 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.
Indications & Usage
Benzonatate capsules is indicated for the symptomatic relief of cough.
Dosage & Administration
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. Benzonatate capsules should be swallowed whole. Benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.
Warnings & Precautions
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).
Contraindications
Hypersensitivity to benzonatate or related compounds.
Adverse Reactions
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.
Storage & Handling
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: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Rev: 07/21
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