Label: CVS EXTRA STRENGTH SMOOTH- calcium carbonate 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 12, 2023

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  • Active ingredient (per tablet)

    Calcium Carbonate USP 750mg

  • 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 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: elemental calcium 300mg
    •
    store at room temperature. Keep the container tightly closed
  • Inactive ingredients

    dextrose, flavors, magnesium stearate, maltodextrin, starch, sucralose,

    Safety sealed: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    Questions

    1-866-467-2748

  • Package/Label Principal Display Panel

    Compare to active ingredient in Extra Strength TUMS® Smoothies™

    Extra Strength

    Smooth Antacid Tablets

    Calcium carbonate, 750 mg

    DYE FREE

    Fast Relief of Upset Stomach, Heartburn, and Acid Indigestion

    Peppermint

    GLUTEN-FREE

    Distributed by:

    *This product is not manufactured or distributed by GlaxoSmithKline LLC, distributor of Extra Strength Tums® Smoothies™.

    CVS Extra Strebgth Smooth Antacid 140 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    CVS  EXTRA STRENGTH SMOOTH
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-405
    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
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize19mm
    FlavorPEPPERMINTImprint Code RP115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-405-40140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/16/2021
    Labeler - CVS PHARMACY (062312574)
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