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Drug Catalog - Product Detail

METAXALONE TB 800MG 100

NDC Mfr Size Str Form
65162-0553-10 AMNEAL PHARMACEUTICALS 100 800MG TABLET
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Description
DESCRIPTION Metaxalone is available as an 800 mg, light pink to pink, capsule shaped, scored uncoated 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: calcium carbonate, FD&C Red #40, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone, silicone dioxide, sodium starch glycolate and sodium stearyl fumarate. Structure
How Supplied
HOW SUPPLIED Metaxalone is available as an 800 mg , light pink to pink, capsule shaped, scored uncoated tablet with debossing ‘AN’ on the left side of the scoring and ‘553’ on the right side of the scoring. Other side of the tablet is plain. They are available as follows: Bottles of 100: NDC 65162-553-10 Bottles of 500: NDC 65162-553-50 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Rx Only Manufactured By: Amneal Pharmaceuticals Co. (I) Pvt. Ltd. Ahmedabad, INDIA 382220 Distributed By: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 05-2012
Indications & Usage
INDICATIONS AND USAGE Metaxalone is 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.