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.
Metaxalone Tablet
FDA Label NDC 80425-0122
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Pharmacy Of Tennessee, Llc for the product Metaxalone (NDC 80425-0122). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding dosage and administration section, indications and usage section, how supplied, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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