Indications and Usage Section 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.

Adverse Reactions Section ADVERSE REACTIONS The most frequent reactions to metaxalone include: CNS: drowsiness, dizziness, headache, and nervousness or “irritability”; Digestive: nausea, vomiting, gastrointestinal upset.

Other adverse reactions are: Immune System: anaphylaxis, hypersensitivity reaction, rash with or without pruritus; Hematologic: leukopenia; hemolytic anemia; Hepatobiliary: jaundice; CNS: cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range and with metaxalone as a single agent taken at doses higher than the recommended dose (see WARNINGS, PRECAUTIONS: DRUG INTERACTIONS, and OVERDOSAGE).

To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-888-838-2872 or FDA at 1-800-FDA-1088 www.fda.gov/medwatch.