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Drug Catalog - Product Detail

METAXALONE 800MG TABLETS 100CT

NDC Mfr Size Str Form
00591-2341-01 ACTAVIS PHARMA 100 800MG TABLET
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Generic Name
METAXALONE
Substance Name
METAXALONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA203695
Description
DESCRIPTION Metaxalone tablets, USP are available as an 800 mg capsule-shaped, scored white to off-white tablet. Chemically, metaxalone is 5-[(3,5- dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C 12 H 15 NO 3 , which corresponds to a molecular weight of 221.25. The structural formula is: Metaxalone is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone and the following inactive ingredients: alginic acid, ammonium alginate, calcium alginate, corn starch, magnesium stearate and pregelatinized starch (starch 1500 partially pregelatinized maize starch). USP Dissolution Test Pending structural formula
How Supplied
HOW SUPPLIED Metaxalone tablets, USP are available as an 800 mg capsule-shaped, scored white to off-white tablet, inscribed with “ 31 90 ” on the scored side and “ WPI ” on the other side. Available in bottles of 100 (NDC 0591-2341-01) and in bottles of 500 (NDC 0591-2341-05). Metaxalone tablets, USP 800 mg has functional scoring. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: April 2017
Indications & Usage
INDICATIONS AND USAGE Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts 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. Metaxalone does not directly relax tense skeletal muscles in man.
Dosage and Administration
DOSAGE AND ADMINISTRATION The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.