Label: DG HEALTH EXTRA STRENGTH ANTACID WINTERGREEN FLAVOR- 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

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

  • Active ingredient (per tablet)

    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

     
    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 as symptoms occur, or as directed by a doctor
    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

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

  • Inactive ingredients

    D&C Yellow No. 10, dextrose, FD&C Blue No. 1, flavor, magnesium stearate, maltodextrin, starch, sucralose

  • Questions or comments?

    1-866-467-2748

  • Package/Label Principal Display Panel

    DGhealth

    NDC# 55910-692-96

    Compare to the active ingredient Tums® Extra Strength*

    Extra Strength 750

    Antacid tablets

    Calcium Carbonate

    Chewable Wintergreen Flavor

    Naturally and Artificially Flavored

    96 Chewable Tablets

    750 mg

    GLUTEN FREE

    100% Satisfaction Guaranteed!

    K PAREVE

    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSION RIDGE, GOODLETTSVILLE,

    TN 37072 USA

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

    DG Health Extra Strength Antacid Calcium Carbonate
  • INGREDIENTS AND APPEARANCE
    DG HEALTH EXTRA STRENGTH  ANTACID WINTERGREEN FLAVOR
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-692
    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
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorGREEN (Mottled) Scoreno score
    ShapeROUNDSize16mm
    FlavorWINTERGREENImprint Code RP102
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-692-9696 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33105/14/2019
    Labeler - DOLGENCORP, LLC (068331990)