MAGNESIUM OXIDE TABLET [H. J. HARKINS COMPANY INC.]

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MAGNESIUM OXIDE TABLET [H. J. HARKINS COMPANY INC.]
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NDC 76519-1155-6
Set ID 60bb4830-2079-17eb-e053-2a91aa0a60ae
Category HUMAN OTC DRUG LABEL
Packager H. J. Harkins Company Inc.
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active Ingredient

    Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)

  • Purpose

    relieves:

    acid indigestion
    upset stomach

  • KEEP OUT OF REACH OF CHILDREN

    Ask a doctor before use if

    you have kidney disease
    you are taking a prescription drug (antacids may interact with certain prescription drugs)
    you are pregnant or breast feeding.

    Do not take more than 2 tablets in a 24 hour period.

    May have a laxative effect.

    Keep out of reach of children.

  • Dosage and Administration

    take one or two antacid tablets daily. Do not exceed two tablets unless directed by a physician.

  • Storage & Handling

    Store at controlled room temperature 15° to 30°C (59° to 86°F).
    Tamper evident, do not use if imprinted safety seal under cap is broken or missing.

  • Inactive Ingredients

    Croscarmellose Sodium, Microcrystalline Cellulose, Silicon Dioxide, and Stearic Acid.

  • Indications & Usage

    Antacid

  • Warnings

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

    Pregnancy or Breast Feeding

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

    Keep Out of Reach of Children

  • Package Label. Prinicpal Display Panel

    76519 1155.jpg

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76519-1155
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize11mm
    FlavorImprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76519-1155-660 in 1 CONTAINER; Type 0: Not a Combination Product06/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/16/2017
    Labeler - H. J. Harkins Company Inc. (147681894)
    Establishment
    NameAddressID/FEIBusiness Operations
    H. J. Harkins Company Inc.147681894manufacture(76519-1155) , relabel(76519-1155) , repack(76519-1155)
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