Label: CALCIUM CARBONATE tablet, chewable

  • NDC Code(s): 51376-127-05
  • Packager: Blessings International
  • 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 December 16, 2019

If you are a consumer or patient please visit this version.

  • 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

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

  • Directions

    For adults and children 12 years 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
  • Inactive ingredients

    assorted flavors, dextrose, D&C Yellow #10 lake, FD&C Blue #1 lake, FD&C Red #40 lake, FD&C Yellow #6 lake, magnesium stearate, maltodextrin. May also contain cellulose, FD&C Yellow #5 lake (tartrazine), stearic acid, sugar.

  • Package label

    1

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51376-127
    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)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    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:51376-127-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/01/2015
    Labeler - Blessings International (064965742)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geri-Care Pharmaceutical Corp611196254repack(51376-127)