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 February 8, 2019

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  • SPL UNCLASSIFIED SECTION

    MAGNESIUM OXIDE 400MG- magnesium oxide 400mg tablet

    Marlex Pharmaceuticals, Inc.

    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.

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    Magnesium Oxide Tablets

  • 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

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    Keep out of reach of children.

  • DIRECTIONS

    Antacid Directions:

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

    Magnesium Supplement Directions:

    • take 1 to 2 tablets daily or as directed by a physician
  • OTHER INFORMATION

    • Magnesium content per tablet: 241.3mg
    • store at room temperature 59°-86° F (15°-30°C)
    • do not use if imprinted safety seal under cap is broken or missing
  • INACTIVE INGREDIENTS

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

    Manufactured for & Distributed by:
    Marlex Pharmaceuticals, Inc.
    New Castle, DE 19720

    Made in the U.S.A.

    Rev. 02/19AH

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0583-62
    Magnesium Oxide
    400 mg
    120 TABLETS

    PRINCIPAL DISPLAY PANEL NDC 10135-0583-62 Magnesium Oxide 400 mg 120 TABLETS

    PRINCIPAL DISPLAY PANEL NDC 10135-0583-62 Magnesium Oxide 400 mg 120 TABLETS

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-583
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 174
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-583-62120 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33102/01/2019
    Labeler - Marlex Pharmaceuticals Inc (782540215)
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