Label: D-CAL KIDS- calcium carbonate granule

  • 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 October 3, 2019

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  • Active ingredient

    Calcium Carbonate 750 mg (in each pouch)

  • Purpose

    Antacid

  • Uses

    Relieves:

    • Heartburn
    • Acid indigestion
    • Sour stomach
    • Upset stomach due to these symptoms
  • Warnings

    Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product:

    • do not take more than 1 pouch in a 24 hour period.
    • use open pouch within two weeks.
  • Keep Out of Reach of Children

  • Directions

    • Find the right dose on chart below based on weight, otherwise use age.
    • Pour powder into cup and add 15mg (0.51 oz.) of water, stir and drink.

    Dosing Chart

    Weight (lbs)

    Age

    Dose

    Under 24

    Under 2 yrs

    Ask a doctor

    24-47

    2-5 yrs

    1/2 pouch

    48-95

    6-11 yrs

    1 pouch
  • Inactive ingredients

    Cholecalciferol, dextrose, maltodextrin, sodium citrate

  • Other Information

    Store in a dry place.

    Do not use if pouch is open or torn.

    Mfg by: A&Z Pharmaceutical, Inc.

    Hauppauge, NY 11788

  • QUESTIONS

    Call toll free 1-800-480-1059 Monday through Friday 9AM-5PM

  • Principal Display Panel - Carton Label

    Carton

    D-Cal® Kids Granules

    Calcium Supplement

    Antacid

    10 pouches

  • Principal Display Panel - Pouch Front Label

    pouch front
  • Principal Display Panel - Pouch Back Label

    Pouch back
  • INGREDIENTS AND APPEARANCE
    D-CAL KIDS 
    calcium carbonate granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62211-239
    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  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62211-239-5710 in 1 BOX01/04/2008
    11 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/04/2008
    Labeler - A&Z Pharmaceutical, Inc. (080225262)
    Registrant - A&Z Pharmaceutical, Inc. (080225262)
    Establishment
    NameAddressID/FEIBusiness Operations
    A&Z Pharmaceutical, Inc.080225262manufacture(62211-239)
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