Label: MAGNESIUM OXIDE tablet

  • NDC Code(s): 54738-974-01
  • Packager: Richmond Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 24, 2019

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  • 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)
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