Label: BI-MART ULTRA STRENGTH ANTACID PEPPERMINT- calcium carbonate tablet, chewable

  • 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 January 11, 2022

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  • ACTIVE INGREDIENT (in each tablet)

    Calcium carbonate 1000 mg

  • PURPOSE

    Antacid

  • USE(S)

    relieves:

    • acid indigestion
    • heartburn
  • WARNINGS

    .

  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

    • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
  • WHEN USING THIS PRODUCT

    do not take more than 7 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

  • IF PREGNANT OR/BREASTFEEDING,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    .

  • DIRECTIONS

    • adults and children 12 years of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor.
  • OTHER INFORMATION

    • each tablet contains: elemental calcium 400 mg
    • do not use if printed seal under the cap is torn or missing
    • store at room temperature. keep the container tightly closed.
  • INACTIVE INGREDIENTS

    corn starch, crospovidone, dextrose, flavor, magnesium stearate, maltodextrin, sucrose, talc.

  • PRINCIPAL DISPLAY PANEL

    *Compare to the active ingredient in Tums® Ultra Strength
    NDC 37835-471-75
    BI-MART

    ULTRA STRENGTH
    ANTACID

    Calcium Carbonate 1000 mg
    FAST RELIEF OF
    ACID INDIGESTION & HEARTBURN

    160 Chewable Tablets
    Peppermint Flavor


    123

  • INGREDIENTS AND APPEARANCE
    BI-MART ULTRA STRENGTH ANTACID PEPPERMINT 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37835-471
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize17mm
    FlavorPEPPERMINTImprint Code G171
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37835-471-75160 in 1 BOTTLE; Type 0: Not a Combination Product03/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33103/21/2019
    Labeler - Bi-Mart (027630078)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(37835-471)
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