Label: DG HEALTH REGULAR STRENGTH 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 USP 500mg

  • 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 15 tablets in 24 hours
    •
    if pregnant do not take more than10 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 200 mg
    •
    store at room temperature. Keep the container tightly closed.
  • Inactive ingredients

    adipic acid, D&C Red No. 27, D&C Yellow No. 10, dextrose, FD&C Blue No. 1, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, starch, sucralose.

    Questions or comments?

    1-866-467-2748

    SAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

  • Package/Label Principal Display Panel

    NDC 55910-510-50

    DG™ health

    Compare to the active ingredient in Tums® Regular Strength*

    Regular Strength 500

    Antacid Tablets

    Calcium Carbonate

    Chewable Assorted Fruit Flavors

    Naturally and Artificially Flavored

    150 Chewable Tablets

    500 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® Regular Strength.

    DG Health Regular Strength Antacid Tablets
  • INGREDIENTS AND APPEARANCE
    DG HEALTH REGULAR STRENGTH  ANTACID
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-510
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorYELLOW, ORANGE, RED, GREENScoreno score
    ShapeROUNDSize16mm
    FlavorFRUIT (Assorted) Imprint Code RP101
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-510-50150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33105/20/2019
    Labeler - DOLGENCORP, LLC (068331990)
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