Label: METAXALONE tablet
- NDC Code(s): 63629-2398-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 64980-472
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 8, 2023
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DESCRIPTIONMetaxalone 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 ...
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CLINICAL PHARMACOLOGYMechanism 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 ...
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INDICATIONS & USAGEMetaxalone 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 ...
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CONTRAINDICATIONSKnown hypersensitivity to any components of this product. Known tendency to drug induced, hemolytic, or other anemias. Significantly impaired renal or hepatic function.
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WARNINGSSerotonin 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 ...
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PRECAUTIONSMetaxalone 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 ...
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ADVERSE REACTIONSThe most frequent reactions to metaxalone include: CNS: drowsiness, dizziness, headache, and nervousness or "irritability"; Digestive: nausea, vomiting, gastrointestinal upset. Other ...
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OVERDOSAGEDeaths 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 ...
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DOSAGE AND ADMINISTRATIONThe recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.
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HOW SUPPLIEDMetaxalone 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 ...
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PRINCIPAL DISPLAY PANELMetaxalone 800 mg Tablet, #100
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INGREDIENTS AND APPEARANCEProduct Information