MAGNESIUM OXIDE TABLET [QUALITEST PHARMACEUTICALS]

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MAGNESIUM OXIDE TABLET [QUALITEST PHARMACEUTICALS]
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NDC 0603-0209-22
Set ID d3c5b01b-f0d6-4503-ab18-b1a72386e2c6
Category HUMAN OTC DRUG LABEL
Packager PAR Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART331
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  • ACTIVE INGREDIENT (In each tablet)

    Magnesium Oxide 400mg (240mg 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 controlled 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

  • PRINCIPAL DISPLAY PANEL

    Magnesium Oxide Tablets 420mg

    Magnesium Oxide Tablets 420mg

     
  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:0603-0209-22120 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33107/01/2014
    Labeler - PAR Pharmaceuticals (092733690)
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