D-CAL KIDS (CALCIUM CARBONATE) GRANULE [A&Z PHARMACEUTICAL, INC.]

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D-CAL KIDS (CALCIUM CARBONATE) GRANULE [A&Z PHARMACEUTICAL, INC.]
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NDC 62211-239-57
Set ID 8c45d37d-01f6-4d0a-83b0-eaa1cfec605f
Category HUMAN OTC DRUG LABEL
Packager A&Z Pharmaceutical, Inc.
Generic Name
Product Class
Product Number
Application Number PART331
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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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