Label: MAGNESIUM OXIDE tablet

  • NDC Code(s): 69367-298-20
  • Packager: Westminster Pharmaceuticals, LLC
  • 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 July 18, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)

  • Purpose

    Antacid

  • Use

    relieves:

    • acid indigestion
    • upset stomach
  • Warnings

    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.

  • Directions

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

    • 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

    Corn Starch, Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid.

  • Questions?

    Call 1-844-221-7294 M-F 9am - 5pm EST

  • PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label

    NDC 69367-298-20

    Magnesium
    Oxide 400 mg

    241.3 mg Elemental Magnesium
    Antacid

    Sugar and Gluten Free

    120 Tablets

    Westminster
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-298
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION400 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize11mm
    FlavorImprint Code AM3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69367-298-20120 in 1 BOTTLE; Type 0: Not a Combination Product10/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33110/15/2020
    Labeler - Westminster Pharmaceuticals, LLC (079516651)