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 April 20, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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.

  • HOW SUPPLIED

    NDC: 63629-2217-1: 100 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Magnesium Oxide 420 mgTablet, #100

    Label
  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-2217(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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 306
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63629-2217-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33111/10/2020
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(63629-2217) , RELABEL(63629-2217)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!