Label: CALCIUM CARBONATE CHEWABLE ANTACID- calcium carbonate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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 4, 2019

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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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