Label: D-CAL KIDS- 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 October 1, 2019

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  • ACTIVE INGREDIENTS

    Calcium Carbonate 750 mg

  • PURPOSES

    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 5 tablets in a 24 hour period. Keep out of reach of children.

    Keep out of reach of children

    Directions

    • chew one tablet daily. If symptoms persist, ask a doctor.

    Other Information

    • store in a dry place
    • do not use if imprinted seal under cap is torn or open

    Inactive ingredients

    cholecalciferol, aspartame, citric acid, D&C Yellow #6, FD&C Blue #1, FD&C Red #40, FD&C Yellow #5, FD&C Yellow #10, flavors, magnesium stearate, sorbitol

  • PRINCIPAL DISPLAY PANEL

    D-Cal Kids_30 Chewable Tab

  • INGREDIENTS AND APPEARANCE
    D-CAL KIDS 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62211-196
    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
    Inactive Ingredients
    Ingredient NameStrength
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeFREEFORMSize17mm
    FlavorImprint Code 0
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62211-196-3030 in 1 BOTTLE; Type 0: Not a Combination Product09/17/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33109/17/1997
    Labeler - A&Z Pharmaceutical, Inc. (080225262)
    Registrant - A&Z Pharmaceutical, Inc. (080225262)
    Establishment
    NameAddressID/FEIBusiness Operations
    A&Z Pharmaceutical, Inc.080225262manufacture(62211-196)
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