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 57896-763-15
Set ID 27d9b505-08bd-4261-a59d-6ddc4031be32
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 stones.

    Ask a doctor or pharmacist before use if you 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

    • adults and children 12 years of age and older:
    • chew 2 to 4 tablets as symptoms occur, or as directed
    by a doctor
    • do not take more than 15 tablets in a 24 hour period
    • if pregnant, do not take more than 10 tablets in 24 hours
    • children under 12 years: consult a doctor

  • Other information

    • each tablet contains: calcium 200 mg
    • Store below 30°C (86°F). Keep the container tightly closed.
    • Tamper Evident: Do not use if imprinted seal under cap is
    missing or broken.

  • Inactive ingredients

    assorted flavors, D&C Yellow #10 lake, dextrose, FD&C Blue #1 lake, FD&C Red #40 lake,
    FD&C Yellow #6 lake, magnesium stearate, maltodextrin,
    mineral oil.

  • Questions or comments?

    1-800-540-3765

  • Package label

    1

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE CHEWABLE ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    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:57896-763-15150 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2020
    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)
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