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 March 27, 2023

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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

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

  • Questions?

    Call Method at 1-877-250-3427 or FDA at 1-800-FDA-1088

    Manufactured for:
    Method Pharmaceuticals, LLC
    Fort Worth, Texas 76118

    Rev. 04/18

  • HOW SUPPLIED

    NDC: 71335-1960-1: 60 Tablets in a BOTTLE

    NDC: 71335-1960-2: 30 Tablets in a BOTTLE

    NDC: 71335-1960-3: 90 Tablets in a BOTTLE

    NDC: 71335-1960-4: 100 Tablets in a BOTTLE

    NDC: 71335-1960-5: 120 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Magnesium Oxide 400mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1960(NDC:58657-120)
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 120
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1960-160 in 1 BOTTLE; Type 0: Not a Combination Product10/06/2021
    2NDC:71335-1960-230 in 1 BOTTLE; Type 0: Not a Combination Product10/06/2021
    3NDC:71335-1960-390 in 1 BOTTLE; Type 0: Not a Combination Product10/06/2021
    4NDC:71335-1960-4100 in 1 BOTTLE; Type 0: Not a Combination Product10/06/2021
    5NDC:71335-1960-5120 in 1 BOTTLE; Type 0: Not a Combination Product10/06/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33107/25/2018
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1960) , RELABEL(71335-1960)
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