Label: KIDS ANTACID- calcium carbonate tablet, chewable

  • NDC Code(s): 55319-151-24
  • Packager: FAMILY DOLLAR SERVICES INC
  • 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 16, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Calcium Carbonate 400 mg

  • Purpose

    Antacid

  • Uses

    relieves:

    ▪
    heartburn
    ▪
    sour stomach
    ▪
    acid indigestion
    ▪
    upset stomach associated with these symptoms
  • Warnings

    Ask a doctor or pharmacist before use if the child is

    ▪
    presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    Stop use and ask a doctor if symptoms last more than two weeks.

    Keep this and all drugs out of the reach of children.

  • Directions

    ▪
    find the right dose on chart below based on weight (preferred), otherwise use age
    ▪
    repeat dose as needed
    ▪
    do not take more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor.

    Dosing Chart

    Weight (lbs.)AgeDose

    under 24

    under 2 yrs

    ask a doctor

    24-47

    2-5 yrs

    1 tablet

    48-95

    6-11 yrs

    2 tablets
  • Other information

    •
    each tablet contains: calcium 160 mg
    •
    sodium free
    •
    store at room temperature, keep tightly closed and dry.
  • Inactive ingredients

    D&C Red No. 40 Lake, dextrose, magnesium stearate, maltodextrin, flavor, sorbitol, starch, sucralose.

  • Questions?

    1-866-467-2748

  • Package Label Principal Display Panel - 24 Tablet Carton

    Compare to the active ingredient in Pepto Kids Antacid Chewables*

    NDC 55319-151-24

    Kid’s Antacid Tablets

    Calcium Carbonate/ Antacid

    Relieves:

    •
    Acid Indigestion
    •
    Heartburn
    •
    Sour Stomach
    •
    Upset Stomach

    For ages 2 to 11 years

    24 Chewable Tablets

    Bubble Gum Flavor

    Naturally and Artificially Flavor

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto Kids Antacid Chewables.

    TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

    Kids Antacid Tablets 24 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    KIDS ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-151
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE400 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SORBITOL (UNII: 506T60A25R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize16mm
    FlavorBUBBLE GUMImprint Code RP151
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-151-241 in 1 CARTON05/08/2023
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33105/08/2023
    Labeler - FAMILY DOLLAR SERVICES INC (024472631)
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