Label: HEB EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUITS- 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 November 28, 2022

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

  • ACTIVE INGREDIENT (in each tablet)

    Calcium carbonate 750 mg

  • PURPOSE

    Antacid

  • USE(S)

    relieves:

    • acid indigestion
    • heartburn
  • 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.
  • OTHER INFORMATION

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

    adipic acid, corn starch, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C red 40 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose, talc.

  • PRINCIPAL DISPLAY PANEL

    Compare to Tums® SmoothiesTM EX active ingredient *
    NDC 37808-137-23
    H E B®
    Extra Strength
    Smooth
    Antacid Tablets

    Calcium Carbonate, 750 mg
    Antacid
    Relief of:

    • Acid Indigestion
    • Heartburn

    Smooth DissolvingAssorted Fruit Flavors
    60 CHEWABLE TABLETS



    173-HEB-60
  • INGREDIENTS AND APPEARANCE
    HEB EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUITS 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-137
    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)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorPINK (light pink) , RED (light red) , ORANGE (light orange) , YELLOW (light yellow) Scoreno score
    ShapeROUNDSize18mm
    FlavorCHERRY, LEMON, ORANGE, STRAWBERRYImprint Code G173
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-137-2360 in 1 BOTTLE; Type 0: Not a Combination Product09/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33109/26/2018
    Labeler - H E B (007924756)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(37808-137)