Label: CVS TROPICAL FRUIT- 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 September 11, 2023

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  • Active ingredient (per tablet)

    Calcium Carbonate USP 1000mg

  • Purpose

    Antacid

  • Uses

    relieves

    •
    heartburn
    •
    acid indigestion
    •
    sour stomach
    •
    upset stomach associated with these symptoms
  • 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 24 hours
    •
    if pregnant do not take more than 5 tablets in 24 hours
  • 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. Do not swallow tablets as whole
    •
    do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
  • Other information

    •
    each tablet contains: calcium 400mg
    •
    store at room temperature. Keep the container tightly closed
  • Inactive ingredients

    adipic acid, D&C yellow 10 lake, dextrose, FD&C Red 40 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose

    Questions?

    1-866-467-2748

    Safety sealed: Do not use if printed seal under cap is torn or missing

  • Package/Label Principal Display Panel

    NDC 51316-003-72

    *Compare to active ingredient in Ultra Strength Tums®

    Ultra Strength

    Antacid Tablets

    Calcium Ccarbonate 1000 mg

    Fast Relief of Upset Stomach, Heartburn, and Acid Indigestion

    Tropical Fruit

    Naturally and Artificially flavored

    72 CHEWABLE TABLETS

    Gluten- Free

    Distributed By

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

    Package Label for 72 Chewable Tablets

    CVS Ultra Strength Antacid Tablets Tropical Fruit 72 Chewable Tablet

    Package Label for 160 Chewable Tablets

    CVS Ultra Strength Antacid Tablets Tropical Fruit 72 Chewable Tablet
  • INGREDIENTS AND APPEARANCE
    CVS  TROPICAL FRUIT
    antacid tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorORANGE (red-orange, cream to off-white, light yellow)) Scoreno score
    ShapeROUNDSize19mm
    FlavorFRUIT (tropical fruit flavor) Imprint Code RP103
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-003-7272 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/05/2021
    2NDC:51316-003-60160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/05/2021
    Labeler - CVS (062312574)
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