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 July 29, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet)

    Magnesium Oxide 400 mg (241.3 mg elemental magnesium)

  • PURPOSE

    Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses

    relieves

    • acid indigestion
    • upset stomach
  • WARNINGS

    Warnings

    Ask a doctor before use if you have kidney disease

    Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacid 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 advice and supervision of a physician

    If pregnant or breast-feeding, ask a professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Directions

    Antacid Directions: take 1 tablet twice a day or as directed by a physician

    Magnesium Supplement Directions: take 1 or 2 tablets day or as directed by a physician

  • STORAGE AND HANDLING

    Other information

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

    Inactive Ingredients

    Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, maize starch

  • QUESTIONS

    Questions or comments?

    1-855-642-2594

  • SPL UNCLASSIFIED SECTION

    Rev.: 04/2022

    Manufactured by:

    APNAR PHARMA LLP

    East Windsor, NJ 08520

    Made in USA

  • PRINCIPAL DISPLAY PANEL

    NDC 24689-132-01

    Magnesium Oxide Tablets 400 mg

    241.3 mg elemental Magnesium per tablet

    Dietary supplement, Antacid

    120 Tablets

    Magnesium Oxide 400mg Tablets label

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-132
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (White to off white) Score2 pieces
    ShapeROUND (Round shaped standard concave) Size11mm
    FlavorImprint Code AM3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24689-132-01120 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/05/2022
    Labeler - APNAR PHARMA LP (079568229)
    Establishment
    NameAddressID/FEIBusiness Operations
    INVAHEALTH INC116840615pack(24689-132) , label(24689-132)
    Establishment
    NameAddressID/FEIBusiness Operations
    APNAR PHARMA LLP118530917manufacture(24689-132) , analysis(24689-132) , pack(24689-132)