CALCIUM CARBONATE CHEWABLE ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [NUCARE PHARMACEUTICALS,INC.]

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CALCIUM CARBONATE CHEWABLE ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [NUCARE PHARMACEUTICALS,INC.]
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NDC 68071-4588-5
Set ID 7782cdf0-361c-421d-e053-2a91aa0af366
Category HUMAN OTC DRUG LABEL
Packager NuCare Pharmaceuticals,Inc.
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active ingredient (in each tablet)

    Calcium Carbonate 500 mg

  • Purpose

    Antacid

  • Uses

    • temporarily relieves: acid indigestion, heartburn, sour stomach
  • Warnings

    Ask a doctor before use if you
    • have kidney disease
    • are taking prescription drugs; antacids may interact with certain prescription drugs

    Stop use and ask a doctor if • symptoms last more than 2 weeks.

    When using this product • do not use the maximum dosage for more than 2 weeks

    If pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • do not exceed recommended dose
    • adults and children 12 years of age and older: chew 2-4 tablets as symptoms occur
    • repeat hourly if symptoms return, or as directed by a physician
    • do not take more than 15 tablets in a 24 hour period
    • children under 12 years: consult a doctor

  • Other information

    • each tablet contains: calcium 200 mg
    • store at room temperature
    • for institutional use only
    • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

  • Inactive ingredients

    assorted flavors, dextrose, D and C Yellow no. 10 lake, FD and C Blue no. 1 lake, FD and C Red no. 40 lake, FD and C Yellow no. 6 lake, magnesium stearate, maltodextrin. May also contain cellulose, FD and C Yellow no. 5 lake (tartrazine), stearic acid, sugar.

  • Package label

    pdp

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE CHEWABLE ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4588(NDC:57896-763)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorred, green, orange, yellowScoreno score
    ShapeROUNDSize14mm
    FlavorCHERRY, LIME, ORANGE, LEMONImprint Code AZ;024
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-4588-5150 in 1 BOTTLE; Type 0: Not a Combination Product10/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/01/2004
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-4588)
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