Drug Catalog - Product Detail
METAXALONE TB 400MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 64720-0126-10 | IMPAX GENERICS | 100 | 400MG | TABLET |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Metaxalone tablets, USP are available as 400 mg round, peach colored tablets. 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, USP 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 400 mg metaxalone, USP and the following inactive ingredients: alginic acid, FD&C Yellow #6 Aluminum Lake, lactose monohydrate, magnesium stearate, povidone and propylene glycol alginate. The structural formula for metaxalone
How Supplied
HOW SUPPLIED Metaxalone tablets USP, 400 mg are peach, round, compressed tablets, debossed cor over 126 on one side the other side is plain. Bottles of 100 (NDC 64720-126-10) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx Only LB# 909-01 Rev. September, 2016 Dist. by: CorePharma, LLC Middlesex, NJ 08846 CorePharma Logo
Indications & Usage
INDICATIONS AND USAGE Metaxalone tablets, USP 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, USP 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 two 400 mg tablets (800 mg) three to four times a day.