MAGNESIUM OXIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]

MAGNESIUM OXIDE TABLET [RICHMOND PHARMACEUTICALS, INC.]
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NDC 54738-973-12
Set ID db5941b2-0a04-452a-8fbc-bd5e40fadfb1
Category HUMAN OTC DRUG LABEL
Packager Richmond Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number PART331
  • ACTIVE INGREDIENT (In each tablet)

    Magnesium Oxide 420 mg

    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: 253 mg

  • INACTIVE INGREDIENTS

     croscarmellose sodium, microcrystalline cellulose, magnesium stearate

  • Questions or Comments

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
    call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

  • PRINCIPAL DISPLAY PANEL

    NDC 54738-974-01- 100 tablets

    IMG_4695

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM OXIDE 
    magnesium oxide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-974
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE420 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (Off) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code AP;137
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54738-974-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/01/2016
    Labeler - Richmond Pharmaceuticals, Inc. (043569607)
    Registrant - Advance Pharmaceutical, Inc (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical, Inc078301063manufacture(54738-974)