FDA Label for Metaxalone
View Indications, Usage & Precautions
Metaxalone Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Rx Pharmacy Of Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Dosage And Administration Section
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.
Indications And Usage Section
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.
How Supplied
HOW SUPPLIED
Metaxalone Tablets, USP are available as 800 mg pink, capsule shaped, scored tablets, debossed “LCI” on one side and “14” bisect “35” on the other side. Available in bottles of 100 (NDC 0527-1435-01) and in bottles of 500 (NDC 0527-1435-05).
Store at 20° C to 25° C (68° to 77°F) [See USP Controlled Room Temperature].
Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136
CIB71144E
Rev. 12/19
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