EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUIT (CALCIUM ANTACID) TABLET, CHEWABLE [CVS]

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EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUIT (CALCIUM ANTACID) TABLET, CHEWABLE [CVS]
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NDC 69842-173-92, 69842-173-94
Set ID ed808369-ef51-4977-9497-c0cb7e79ac6e
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active ingredient (in each tablet)

    Calcium carbonate 750 mg


  • Purpose

    Antacid

  • KEEP OUT OF REACH OF CHILDREN


  • 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 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 printed seal under cap is torn or missing.
    • store at room temperature. keep the container tightly closed.
  • Inactive ingredients

    adipic acid, corn starch, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, FD&C red 40 lake, flavors, microcrystalline cellulose, magnesium stearate, maltodextrin, sorbitol, sucrose, talc

  • PRINCIPAL DISPLAY PANEL

    *Compare to the active ingredient inTUMS® Smooth Extra Strength

    Extra Strength Smooth Antacid Tablets

    Calcium Carbonate 750 mg

    Assorted Fruit Flavor

    140 chewable Tablets

    Label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUIT 
    calcium antacid tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-173
    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
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorpink, orange, yellow, redScoreno score
    ShapeROUNDSize16mm
    FlavorFRUIT (lemon, strawberry, cherry, orange) Imprint Code G173
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-173-94140 in 1 BOTTLE; Type 0: Not a Combination Product09/05/2016
    2NDC:69842-173-9260 in 1 BOTTLE; Type 0: Not a Combination Product11/03/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/03/2014
    Labeler - CVS (062312574)
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