Label: DG HEALTH EXTRA STRENGTH ASSORTED FRUITS 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 September 2, 2023

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  • Active ingredient (per tablet)

    Calcium Carbonate 750 mg

  • 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 a 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 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.

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

  • Inactive ingredients

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

    Questions or comments

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    DG™ health

    NDC 55910-605-60

    Compare to the active ingredient of Tums® Smoothies™ Extra Strength

    EXTRA STRENGTH 750

    Antacid Tablets

    Calcium Carbonate

    Smooth Dissolve
    Chewable Assorted Fruit Flavors

    Naturally and Artificially Flavored


    60 Chewable Tablets

    750 mg

    K PAREVE

    GLUTEN-FREE
    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSION RIDGE, GOODLETTSVILLE,

    TN 37072 USA

    100% Satisfaction Guaranteed

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

    Extra Strength Antacid Tablets Fruit Flavor
  • INGREDIENTS AND APPEARANCE
    DG HEALTH EXTRA STRENGTH  ASSORTED FRUITS ANTACID
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-605
    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 (light pink) , RED (light red) , ORANGE (light orange) , YELLOW (light yellow) Scoreno score
    ShapeROUNDSize18mm
    FlavorFRUIT (Assorted) Imprint Code RP115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-605-6060 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33105/16/2019
    Labeler - DOLGENCORP, LLC (068331990)
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