Drug Catalog - Product Detail
BENZONATE CAPS 100MG 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 67877-0573-01 | ASCEND LABORATORIES | 100 | 100MG | CAPSULE |
PACKAGE FILES
Generic Name
BENZONATATE
Substance Name
BENZONATATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA040627
Description
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 soft gelatin capsule, for oral administration, contains 100 mg, 150 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, purified water, methylparaben and propylparaben.
How Supplied
HOW SUPPLIED Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted “105”, available in bottles of 100’s (NDC 67877-573-01), and 500’s (NDC 67877-573-05). Benzonatate Capsules USP, 150 mg: Yellow soft gelatin capsules, imprinted "128", available in bottles of 100 (NDC 67877-574-01). Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted “106”, available in bottles of 100’s (NDC 67877-575-01) and 500’s (NDC 67877-575-05). Store at 20°C to 25° C (68°F to 77°F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT . Manufactured by: Softgel Healthcare Pvt. Ltd., Survey No. 20/1, Vandalur-Kelambakkam Road, Pudupakkam, Chengalpattu, Tamilnadu - 603 103, India. Distributed by: Ascend Laboratories, LLC Bedminster, NJ 07921 Revised: November 2025 PT3732-01 (2411326)
Indications & Usage
INDICATIONS & USAGE Benzonatate USP is indicated for the symptomatic relief of cough.
Dosage and Administration
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 should be swallowed whole . Benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.