Label: MAGNESIUM OXIDE 400MG tablet

  • NDC Code(s): 68210-4105-1
  • Packager: Spirit 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 November 30, 2021

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  • ACTIVE INGREDIENT (In each tablet)

    Magnesium Oxide 400mg (241.3mg elemental magnesium)

    Purpose

    Antacid

  • USES

    relieves

    • acid indigestion
    • upset stomach
  • WARNINGS

    Ask a doctor if you have

    kidney disease

    Ask a doctor or pharmacist before use if you are

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

    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 advise and supervision of a physician. May have a laxative effect.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    Keep out of reach of children.

  • DIRECTIONS

    • take 1 tablet twice a day or as directed by a physician
  • OTHER INFORMATION

    • Magnesium content per tablet: 241.3mg
    • store at room temperature 59°-86° F (15°-30°C)
  • INACTIVE INGREDIENTS

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

  • Questions or comments?

    1-888-333-9792

  • PDP

    Cabinet:

    Antacid

    Magnesium Oxide 400mg

    75 Tablets

    image description

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 400MG 
    magnesium oxide 400mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4105
    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
    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:68210-4105-175 in 1 BOTTLE; Type 0: Not a Combination Product07/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33107/02/2020
    Labeler - Spirit Pharmaceuticals LLC (179621011)