Label: MAGNESIUM OXIDE tablet

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 25, 2013

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  • ACTIVE INGREDIENTS

    Magnesium Oxide 400mg (241.3mg elemental magnesium)

    Purposes

    Antacid

  • USES

    Relieves: (acid indigestion (upset stomach

  • WARNINGS

    Do Not Use

    Do not take more than 2 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a physician. May have a laxative effect.

    Ask a Doctor if you have:

    Kidney disease

    Ask a Doctor/Pharmacist before use if you are:

    Taking a prescription drug. Antacids may interact with certain prescription drugs.

    Pregnancy or Breast Feeding

    If pregnant or breast feeding, ask a health professional before use.

    Keep Out of Reach of Children

  • DIRECTIONS

    Antacid Directions: (take 1 tablet twice a day or as directed by a physician

    Magnesium Supplement Directions: (take 1 to 2 tablets daily or as directed by a physician

  • OTHER INFORMATION

    (store at room temperature 59°-86° F (15°-30°C) (do not use if imprinted safety seal under cap is broken or missing (Magnesium content per tablet: 240 mg

  • INACTIVE INGREDIENTS

    Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid

  • PACKAGE LABEL

    Label Image for 400mg

    Label Image for 400mg
  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-0684(NDC:0603-0209)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE400 mg
    Inactive Ingredients
    Ingredient NameStrength
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 174
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53808-0684-130 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33101/01/2013
    Labeler - State of Florida DOH Central Pharmacy (829348114)
    Establishment
    NameAddressID/FEIBusiness Operations
    State of Florida DOH Central Pharmacy829348114repack(53808-0684)
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