Label: CHILDRENS TUMMY RELIEF- 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 February 16, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Calcium carbonate USP 400 mg

  • PURPOSE

    Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses

    relieves

    • heartburn
    • acid indigestion
    • sour stomach
    • upset stomach associated with these symptoms
  • WARNINGS

    Warnings

    Ask a doctor or pharmacist before use if the child is presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    • do not give the child more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in 24 hours
    • do not give the child the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    Find right dose on chart below based on weight (preferable); otherwise use age

    WeightAgeDose
    over 48 lbs.6-11 yearschew 2 tablets as symptoms occur, not to exceed 6 tablets in 24 hours
    24-47 lbs.2-5 yearschew 1 tablet as symptoms occur, not to exceed 3 tablets in 24 hours
    under 24 lbs.under 2 yearsask a doctor

  • SPL UNCLASSIFIED SECTION

    Other information

    • each tablet contains: elemental calcium 160 mg
    • store between 20-25°C (68-77°F) in a dry place out of direct sunlight
  • INACTIVE INGREDIENT

    Inactive ingredients

    organic beet root, organic carnauba wax, dextose, organic flavors, organic maltodextrin, organic rice bran extract

  • QUESTIONS

    Questions?

    1-855-436-3921

  • SPL UNCLASSIFIED SECTION

    Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.

    Patent Pending I Distributed by:

    Genexa Inc. Atlanta, GA 30318

    genexa.com

  • SPL UNCLASSIFIED SECTION

    Made in the USA with globally sourced ingredients

    R-20220321

    NDC 69676-0060-7

  • PRINCIPAL DISPLAY PANEL

    Children's

    Genexa®

    MEDICINE MADE CLEAN

    Ages 2-11

    Tummy Relief

    Calcium Carbonate Antacid

    Heartburn

    Sour Stomach

    Acid Indigestion

    Upset Stomach

    Compare to active ingredient in Pepto Bismol® Kids

    Chewable Tablets Bubblegum*

    How we're different

    Made without: talc, D&C red no. 27 aluminum lake, sorbitol & more!

    Organic Berry & Vanilla Flavor

    30 Chewable Tablets

    23A_Tummy-Relief_Childrens_Carton_R-20220321

  • INGREDIENTS AND APPEARANCE
    CHILDRENS TUMMY RELIEF 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0060
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE400 mg
    Inactive Ingredients
    Ingredient NameStrength
    BEET (UNII: N487KM8COK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    RICE BRAN (UNII: R60QEP13IC)  
    Product Characteristics
    Colorpink (Tan) Scoreno score
    ShapeROUNDSize13mm
    FlavorVANILLA, BERRYImprint Code G;strawberry
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0060-71 in 1 CARTON10/21/2022
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33110/21/2022
    Labeler - Genexa Inc. (079751024)
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