Label: EXTRA STRENGTH SMOOTH- antacid tablets tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 14, 2023

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  • 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 tablet contains: calcium 300mg

    • Store at room temperature. Keep the container tightly closed

  • Inactive ingredients

    adipic acid, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Red No. 40 Lake, FD&C Yellow No. 6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose

    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® Smoothies™

    EXTRA STRENGTH

    Smooth Antacid Tablets

    Calcium Carbonate 750 mg

    Assorted Fruit

    Naturally and Artificially Flavored

    For Fast Relief of Heartburn, Acid Indigestion & Upset Stomach

    60 Chewable Tablets

    Distributed by:

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

    Extra Strength Smooth Antacid Tablets Assorted Fruit
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH SMOOTH 
    antacid tablets tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-516
    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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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
    ColorPINK (dark pink) , ORANGE, YELLOWScoreno score
    ShapeROUNDSize19mm
    FlavorFRUIT (Assorted) Imprint Code RP115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-516-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00110/01/2020
    Labeler - SAFEWAY (009137209)
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