Label: CVS PHARMACY,INC. ASSORTED FRUIT- antacid tablets tablet, chewable

  • NDC Code(s): 51316-201-50, 51316-201-96
  • Packager: CVS PHARMACY,INC.
  • 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 September 11, 2023

If you are a consumer or patient please visit this version.

  • Active ingredient

    Calcium Carbonate USP 750mg

  • Purpose

    Antacid

  • Uses

    relieves:

    • heartburn

    • sour stomach

    • acid indigestion

    • upset stomach associated with these symptoms

  • Warnings

    Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    • do not take more than 10 tablets in 24 hours

    • if pregnant do not take more than 6 tablets in 24 hours

    • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

  • Keep out of reach of children

  • Directions

    • adults and children 12 years of age and over: chew 2-4 tablets completely as symptoms occur, or as directed by a doctor. Do not swallow tablets whole.

    • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

  • Other Information

    • each tablets contains: calcium 300mg

    • Store at room temperature. Keep the container tightly closed

  • Inactive ingredients

    adipic acid, D&C Red No. 27 Lake, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow no. 6 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

  • Questions or comments?

    1-866-467-2748

    SAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

  • Package/Label Principal Display Panel

    *Compare to the active ingredient in Extra Strength Tums®

    NDC 51316-201-96

    EXTRA STRENGTH

    Antacid Tablets

    Calcium Carbonate 750 mg

    Fast Relief of Upset Stomach, Heartburn, and Acid Indigestion

    Assorted Fruit

    Naturally and Artificially Flavored

    96 Chewable Tablets

    Distributed by

    *This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Extra Strength Tums®

    Package Label for 96 Chewable tablets

    CVS Extra  Strength Assorted Fruit 96 Chewable Tablets

    Package Label for 250 Chewable tablets

    CVS Extra Strength Assorted Fruit 250 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY,INC.  ASSORTED FRUIT
    antacid tablets tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-201
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorGREEN, ORANGE, PINK, YELLOWScoreno score
    ShapeROUNDSize16mm
    FlavorFRUIT (ASSORTED) Imprint Code RP102
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-201-9696 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/23/2021
    2NDC:51316-201-50250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33107/23/2021
    Labeler - CVS PHARMACY,INC. (062312574)