Label: EXTRA STRENGTH SMOOTH ANTACID- 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 January 6, 2022

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  • ACTIVE INGREDIENT (in each tablet)

    Calcium carbonate 750 mg

  • PURPOSE

    Antacid

  • USE(S)

    relieves:

    • acid indigestion
    • heartburn
    • 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 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 2-4 tablets as symptoms occur, or as directed by a doctor.
    • do not take for symptoms that persists for more than 2 weeks unless advised by a doctor.
  • OTHER INFORMATION

    • each tablet contains: elemental calcium 300 mg
    • store at room temperature. keep the container tightly closed.
  • INACTIVE INGREDIENTS

    adipic acid, corn starch, dextrose, FD&C blue 1 lake, FD&C red 40 lake, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose, talc.

  • PRINCIPAL DISPLAY PANEL

    Extra Strength
    Smooth
    Antacid Tablets
    evens
    Chill Berries 
    Calcium Carbonate 750 mg

    60 Chewable Tablets

    Compare to the active ingredient  in TUMS®SmoothiesTM EX



    44

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH SMOOTH ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71713-204
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    SORBITOL (UNII: 506T60A25R)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorRED (light red) , BLUE (light blue) , PINK (light pink) Scoreno score
    ShapeROUNDSize16mm
    FlavorBERRY (STRAWBERRY, RASPBERRY, WIDBERRY) , CHERRYImprint Code G173
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71713-204-0360 in 1 BOTTLE; Type 0: Not a Combination Product05/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33105/17/2019
    Labeler - Thirty Madison Inc (080774087)
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