Label: METAXALONE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 8, 2023

If you are a consumer or patient please visit this version.

  • DESCRIPTION
    Metaxalone tablets, USP are available as an 800 mg oval, scored pink tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C12H15NO3 ...
  • CLINICAL PHARMACOLOGY
    Mechanism of Action - The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system (CNS) depression. Metaxalone has no direct action ...
  • INDICATIONS & 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 ...
  • CONTRAINDICATIONS
    Known hypersensitivity to any components of this product. Known tendency to drug induced, hemolytic, or other anemias. Significantly impaired renal or hepatic function.
  • WARNINGS
    Serotonin Syndrome - Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with metaxalone tablets used within the ...
  • PRECAUTIONS
    Metaxalone tablets should be administered with great care to patients with pre-existing liver damage. Serial liver function studies should be performed in these patients. False-positive ...
  • ADVERSE REACTIONS
    The most frequent reactions to metaxalone include: CNS: drowsiness, dizziness, headache, and nervousness or "irritability"; Digestive: nausea, vomiting, gastrointestinal upset. Other ...
  • OVERDOSAGE
    Deaths by deliberate or accidental overdose have occurred with metaxalone, particularly in combination with antidepressants, and have been reported with this class of drug in combination with ...
  • 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.
  • HOW SUPPLIED
    Metaxalone tablets, USP are available as an 800 mg oval, scored pink tablet debossed with AC 127 separated by break line on one side and plain on the other side. Available in bottles of 100 (NDC ...
  • PRINCIPAL DISPLAY PANEL
    Metaxalone 800 mg Tablet, #100
  • INGREDIENTS AND APPEARANCE
    Product Information