Drug Catalog - Product Detail
CHLORZOXAZONE TB 500MG 500
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00591-2520-05 | ACTAVIS PHARMA | 500 | 500MG | TABLET |
PACKAGE FILES
Generic Name
CHLORZOXAZONE
Substance Name
CHLORZOXAZONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA089859
Description
DESCRIPTION Chlorzoxazone, USP is a centrally-acting skeletal muscle relaxant, available as tablets of 500 mg for oral administration. Its chemical name is 5-Chloro-2-benzoxazolinone, and its structural formula is: Chlorzoxazone, USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone, USP is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia. Chlorzoxazone Tablets, USP contain the inactive ingredients docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellullose, pregelatinized starch, sodium benzoate, and sodium starch glycolate. chemical structure
How Supplied
HOW SUPPLIED Chlorzoxazone Tablets USP, 500 mg are available as oblong, scored, white tablets debossed with "WPI" on one side and "39|68" on the other side and are packaged in bottles of 100 (NDC 0591-2520-01) and 500 (NDC 0591-2520-05). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP/NF. Keep this and all medications out of the reach of children. Manufactured In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. B 8/2024
Indications & Usage
INDICATIONS Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.
Dosage and Administration
DOSAGE AND ADMINISTRATION Usual Adult Dosage One tablet three or four times daily. If adequate response is not obtained with this dose, it may be increased to one and one-half tablets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.