Label: D-CAL- calcium carbonate tablet, chewable

  • NDC Code(s): 62211-166-60
  • Packager: A&Z Pharmaceutical 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 October 3, 2019

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  • Active ingredient (in each tablet)

    Calcium Carbonate 750 mg

    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 10 tablets for adults and 5 tablets for children in a 24 hour period.

    Keep out of reach of children.

    Directions

    • Adults: chew 2 tablets daily.
    • Children: chew 1 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, D&C red #27, flavors, magnesium stearate, sorbitol

  • PRINCIPAL DISPLAY PANEL

    D-Cal_60 Chewable Tab_Hauppauge.jpg

  • INGREDIENTS AND APPEARANCE
    D-CAL 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62211-166
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeRECTANGLESize17mm
    FlavorTROPICAL FRUIT PUNCHImprint Code DCAL;AZ
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62211-166-6060 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(62211-166)