Label: MAGNESIUM OXIDE tablet

  • NDC Code(s): 10135-721-01
  • Packager: Marlex Pharmaceuticals Inc.
  • 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 April 25, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT (In each tablet)

    Magnesium Oxide 420 mg

  • Purpose

    Antacid

  • Supplement Facts

    Serving Size

    1 Tablet

    Magnesium (as Magnesium Oxide)

    Amount per Serving

    253mg

    % Daily value

    63%

  • Other Ingredients

    Colloidal silicon dioxide, Croscarmellose sodium, microcrystalline cellulose, stearic acid

    Magnesium oxide may help with magnesium deficiencies.*

  • SUGGESTED USE

    As a dietary supplements, adult take one (1) tablet daily preferably with food or as directed by your healthcare practitioner.

  • CAUTIONS

    If you are pregnant, nursing, taking any medications or have any medical condition, consult your doctor before use. If you have any kidney disease, take only under the supervision of a doctor. Discontinue use and consult your doctor if any adverse reaction occurs.

    Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

    Store in a cool, dry place.

  • WARNINGS

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

  • SPL UNCLASSIFIED SECTION

    * These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

  • SPL UNCLASSIFIED SECTION

    Manufactured for/ Distributed by:

    Marlex Pharmaceuticals, Inc.

    New Castle, DE 19720

    Rev. 04/22 AH

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0721-01

    Magnesium Oxide 420 mg

    100 TABLETS

    l-n

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-721
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE420 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-721-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/25/2022
    Labeler - Marlex Pharmaceuticals Inc. (782540215)