MAGNESIUM OXIDE TABLET [METHOD PHARMACEUTICALS, LLC]

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MAGNESIUM OXIDE TABLET [METHOD PHARMACEUTICALS, LLC]
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NDC 58657-120-12
Set ID 0af63651-f9d9-43b9-b6f0-4878466a82e6
Category HUMAN OTC DRUG LABEL
Packager Method Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number PART331
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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

  • Principal Display Panel

    NDC 58657-120-12
    Magnesium Oxide
    400 mg
    241.3 Elemental Magnesium
    Antacid
    120 Tablets

    NDC 58657-120-12 Magnesium Oxide 400 mg 241.3 Elemental Magnesium Antacid 120 Tablets

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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)  
    CELLULOSE, MICROCRYSTALLINE (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:58657-120-12120 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33107/25/2018
    Labeler - Method Pharmaceuticals, LLC (060216698)
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