Label: EXTRA STRENGTH SMOOTH ANTACID- calcium carbonate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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 May 8, 2017

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  • Active ingredient (in each tablet)

    Calcium carbonate 750 mg

  • Purpose

    Antacid

  • Uses

    relieves: acid indigestion, heartburn

  • KEEP OUT OF REACH OF CHILDREN


  • 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 10 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 breast-feeding ask a health professional before use.

    Keep out of reach of children

  • Directions

    • adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor
  • Other information

    • each tablet contains: elemental calcium 300 mg
    • do not use if pull tab seal under cap is torn or missing
    • store at room temperature. keep the container tightly closed.
  • Inactive ingredients

    corn starch, dextrose, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose, talc

  • PDP

    Compare to TUMS® Smoothies E-X active ingredient

    Extra Strength Smooth Antacid Tablets

    Calcium Carbonate 750 mg

    Peppermint 

    140 chewable Tablets

    label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH SMOOTH ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-716
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize19mm
    FlavorPEPPERMINTImprint Code G173
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-716-94140 in 1 BOTTLE; Type 0: Not a Combination Product09/02/2016
    2NDC:69842-716-9260 in 1 BOTTLE; Type 0: Not a Combination Product11/03/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/03/2015
    Labeler - CVS (062312574)
    Registrant - Guardian Drug Company (119210276)
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