Label: MAGNESIUM OXIDE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 December 19, 2017

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  • Active Ingredient

    Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)

  • Purpose

    relieves:

    acid indigestion
    upset stomach

  • KEEP OUT OF REACH OF CHILDREN

    Ask a doctor before use if

    you have kidney disease
    you are taking a prescription drug (antacids may interact with certain prescription drugs)
    you are pregnant or breast feeding.

    Do not take more than 2 tablets in a 24 hour period.

    May have a laxative effect.

    Keep out of reach of children.

  • Dosage and Administration

    take one or two antacid tablets daily. Do not exceed two tablets unless directed by a physician.

  • Storage & Handling

    Store at controlled room temperature 15° to 30°C (59° to 86°F).
    Tamper evident, do not use if imprinted safety seal under cap is broken or missing.

  • Inactive Ingredients

    Croscarmellose Sodium, Microcrystalline Cellulose, Silicon Dioxide, and Stearic Acid.

  • Indications & Usage

    Antacid

  • Warnings

    Do not take this product if you are presently taking a prescription drug without consulting your physician or other health care professional. If you have kidney disease, take only under the supervision of a physician. May have a laxative effect. If pregnant or breast-feeding, ask a health professional before use.

    Pregnancy or Breast Feeding

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

    Keep Out of Reach of Children

  • Package Label. Prinicpal Display Panel

    76519 1155.jpg

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76519-1155
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize11mm
    FlavorImprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76519-1155-660 in 1 CONTAINER; Type 0: Not a Combination Product06/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/16/2017
    Labeler - H. J. Harkins Company Inc. (147681894)
    Establishment
    NameAddressID/FEIBusiness Operations
    H. J. Harkins Company Inc.147681894manufacture(76519-1155) , relabel(76519-1155) , repack(76519-1155)
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