MAGNESIUM OXIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]

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MAGNESIUM OXIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]
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NDC 71610-182-60
Set ID 11b2ce71-61fd-4e75-a859-a260b1dda080
Category HUMAN OTC DRUG LABEL
Packager Aphena Pharma Solutions - Tennessee, LLC
Generic Name
Product Class
Product Number
Application Number PART331
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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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