Label: MAGNESIUM OXIDE tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 21, 2023

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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 DrugM00108/05/2022
    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)
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