MAGNESIUM OXIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]

MAGNESIUM OXIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]
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NDC 53808-0684-1
Set ID b9d11379-a86d-4cc5-bbe4-8444db7bce5a
Category HUMAN OTC DRUG LABEL
Packager State of Florida DOH Central Pharmacy
Generic Name
Product Class
Product Number
Application Number PART331
  • ACTIVE INGREDIENTS

    Magnesium Oxide 400mg (241.3mg elemental magnesium)

    Purposes

    Antacid

  • USES

    Relieves: (acid indigestion (upset stomach

  • WARNINGS

    Do Not Use

    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. May have a laxative effect.

    Ask a Doctor if you have:

    Kidney disease

    Ask a Doctor/Pharmacist before use if you are:

    Taking a prescription drug. Antacids may interact with certain prescription drugs.

    Pregnancy or Breast Feeding

    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

  • PACKAGE LABEL

    Label Image for 400mg

    Label Image for 400mg
  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-0684(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
    COLLOIDAL 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:53808-0684-130 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33101/01/2013
    Labeler - State of Florida DOH Central Pharmacy (829348114)
    Establishment
    NameAddressID/FEIBusiness Operations
    State of Florida DOH Central Pharmacy829348114repack(53808-0684)

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