Label: ANTACID RELIEF- 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 22, 2016

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  • Active ingredient (in each tablet)

    Calcium carbonate 1000 mg

  • Purpose

    Antacid

  • Uses

    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

    Keep out of reach of children.

    If pregnant or breast feeding, ask a health professional before use.

  • 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 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

  • PDP

    Compare to the TUMS Ultra strength active ingredient

    Ultra strength

    Antacid Relief Tablets

    Calcium Carbonate 1000 mg

    Peppermint Flavor

    Chewable

    Rich in calcium

    Relief of: acid indigestion/heartburn

    72 tablets

    LBL

  • INGREDIENTS AND APPEARANCE
    ANTACID RELIEF 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-472
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize17mm
    FlavorPEPPERMINTImprint Code G171
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-472-6872 in 1 BOTTLE; Type 0: Not a Combination Product11/11/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/11/2015
    Labeler - Safeway (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276manufacture(21130-472)
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