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 7, 2018

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  • ACTIVE INGREDIENT (In each tablet)

    Magnesium Oxide 400mg (241.3mg elemental magnesium)

    Purpose

    Antacid

  • USES

    Relieves: ■ acid indigestion  ■ upset stomach

  • WARNINGS

    Ask a doctor if you have:

    kidney disease

    Ask a doctor or pharmacist before use if you are:

    taking a prescription drug. Antacids 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 advise and supervision of a physician. May have a laxative effect.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep Out of Reach of Children.

  • DIRECTIONS

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

    Magnesium Supplement Directions: ■ take 1 to 2 tablets daily or as directed by a physician

  • OTHER INFORMATION

    ■ store at room temperature 59°-86° F (15°-30°C) ■ do not use if imprinted safety seal under cap is broken or missing

    ■ Magnesium content per tablet: 240 mg

  • INACTIVE INGREDIENTS

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

  • Repackaging Information

    Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

    Count400 mg
    9071610-182-60

    Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

    Repackaged by:
    Aphena Pharma Solutions - TN
    Cookeville, TN 38506

    20181107JH

  • PRINCIPAL DISPLAY PANEL - 400 mg

    NDC 71610-182 - Magnesium Oxide 400 mg - Rx Only
    Bottle Label 400 mg

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-182(NDC:0603-0209)
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 174
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71610-182-6090 in 1 BOTTLE; Type 0: Not a Combination Product10/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33112/03/2003
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-182)
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