Label: METAXALONE tablet

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

Drug Label Information

Updated June 3, 2014

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

  • PRINCIPAL DISPLAY PANEL

    NDC: 51655-0162-10

    MFG: 65162-553-10

    Metaxalone, USP

    800mg

    10 tablets

    Rx Only

    Dosage: See Package insert

    Store below 77 degrees F. (25 degrees C)

    Store in a tight, light resistant container (See USP).

    Keep out of the reach of children.

    Each tablet contains Metaxalone, USP...800mg

    Mfg. By Amneal Pharmaceuticals Co. Pvt. Ltd Ahmedabad, India 38220

    Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

    Lot#:

    Exp. Date:

    Metaxalone 51655-162-10

  • PRINCIPAL DISPLAY PANEL

    NDC: 51655-162-20

    MFG: 65162-553-10

    Metaxalone Tablets, USP

    800 mg

    20 Tablets

    Rx only

    Dosage: See package insert

    Store below 77 degrees F.

    Store in a tight, light resistant container (See USP)  Keep out of the reach of children.

    Mfg by: Amneal Pharmaceuticals Co. Pvt. Ltd. Ahmedabad, India 38220

    Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

    Lot #:

    Exp. Date:

    Metaxalone 51655-162-20

  • Warnings

    WARNINGS

    Metaxalone may enhance the effects of alcohol and other CNS depressants.

    PRECAUTIONS

    Metaxalone 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 Benedict’s tests, due to an unknown reducing substance, have been noted. A glucose-specific test will differentiate findings.

    Taking metaxalone with food may enhance general CNS depression; elderly patients may be especially susceptible to this CNS effect. (See CLINICAL PHARMACOLOGY: Pharmacokinetics and PRECAUTIONS: Information for Patients section).

    Information for Patients

    Metaxalone may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle, especially when used with alcohol or other CNS depressants.

    Drug Interactions

    The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    The carcinogenic potential of metaxalone has not been determined.

    Pregnancy

    Reproduction studies in rats have not revealed evidence of impaired fertility or harm to the fetus due to metaxalone. Post marketing experience has not revealed evidence of fetal injury, but such experience cannot exclude the possibility of infrequent or subtle damage to the human fetus. Safe use of metaxalone has not been established with regard to possible adverse effects upon fetal development. Therefore, metaxalone tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless, in the judgement of the physician, the potential benefits outweigh the possible hazards.

    Nursing Mothers

    It is not known whether this drug is secreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

    Pediatric Use

    Safety and effectiveness in children 12 years of age and below have not been established.

  • Adverse Reactions

    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: hypersensitivity reaction, rash with or without pruritus;

    Hematologic: leukopenia; hemolytic anemia;

    Hepatobiliary: jaundice.

    Though rare, anaphylactoid reactions have been reported with metaxalone.

  • Dosage and Administration

    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.

  • Online drug information link

    For more information regarding this drug please see the manufacturer's information online at:

    Permanent Link:

    http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3aa9dba9-29b0-4520-a0f7-66d19d52c6bc

  • INGREDIENTS AND APPEARANCE
    METAXALONE 
    metaxalone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-162(NDC:65162-553)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METAXALONE (UNII: 1NMA9J598Y) (METAXALONE - UNII:1NMA9J598Y) METAXALONE800 mg
    Product Characteristics
    ColorpinkScoreno score
    ShapecapsuleSize19mm
    FlavorImprint Code AN;553
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-162-1010 in 1 BOTTLE, DISPENSING
    2NDC:51655-162-2020 in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20339902/12/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-162)