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 November 10, 2020

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

  • Active ingredient(s)

    Magnesium Oxide 

  • Purpose

    Magnesium Oxide may help in magnesium deficiencies †

  • Use(s)

    As a dietary supplement.

  • Warnings

    Do not use

    Do not take this product if you are presently taking a prescription drug without consulting your physician or other health care professional. If you have kidney disease, take only under the supervision of a physician. May have a laxative effect.

    Pregnancy/Breastfeeding

    ask a health professional before use.

    Keep out of reach of children

  • Directions

    Take one tablet daily or as directed by a physician.

  • Other information

    This product is sealed for your protection. Do not use if imprinted safety seal under cap is broken or missing.

  • Storage

    Keep tightly closed and store in a cool, dry place.

  • Inactive ingredients

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

  • Principal Display Panel

    Magnesium Oxide

    †These statements have not been evaluated by The Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure or prevent any disease. Manufactured for: Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811 USA


  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0213
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE253 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 306
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0603-0213-21100 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/10/2020
    Labeler - PAR Pharmaceuticals (092733690)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930analysis(0603-0213) , label(0603-0213) , manufacture(0603-0213) , pack(0603-0213)