Label: ULTRA STRENGTH ANTACID- calcium antacid 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 August 9, 2017

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  • Active ingredient (in each tablet)

    Calcium carbonate 1000 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 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 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 2-3 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

    adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

  • Principal Display Panel

    CVS Health

    Compare to active ingredient in TUMS® Ultra strength 

    Ultra Strength Antacid Tablets

    Calcium Carbonate 1000 mg

    Assorted Fruit Flavor

    72 Chewable Tablets

    Label

  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH ANTACID 
    calcium antacid tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-171
    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
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    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)  
    Product Characteristics
    Colororange, yellow, green, pink (reddish-pink) Scoreno score
    ShapeROUNDSize17mm
    FlavorFRUIT (orange, cherry, lemon, lime) Imprint Code G171
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-171-6872 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2011
    2NDC:69842-171-72160 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/09/2011
    Labeler - CVS (062312574)
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