CALCIUM CARBONATE CHEWABLE ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GERI-CARE PHARMACEUTICAL CORP]

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CALCIUM CARBONATE CHEWABLE ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GERI-CARE PHARMACEUTICAL CORP]
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NDC 57896-762-15
Set ID 616bb658-5d0c-de11-e053-2991aa0a46b8
Category HUMAN OTC DRUG LABEL
Packager Geri-Care Pharmaceutical Corp
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
    • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • Inactive ingredients

    adipic acid, dextrose, FD&C blue #1
    aluminum lake, FD&C red #40 aluminum lake, FD&C yellow
    #5 aluminum lake (tartrazine), FD&C yellow #6 aluminum lake,
    flavors, maltodextrin, mineral oil, polyethylene glycol,
    powdered cellulose, talc

  • Package label

    762

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE CHEWABLE ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-762
    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
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TALC (UNII: 7SEV7J4R1U)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Colorred, green, orange, yellowScoreno score
    ShapeROUNDSize14mm
    FlavorCHERRY, LIME, ORANGE, LEMONImprint Code 763
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-762-15150 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/01/2004
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geri-Care Pharmaceutical Corp611196254repack(57896-762)
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