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

  • NDC Code(s): 57896-763-15
  • Packager: Geri-Care Pharmaceutical Corp
  • 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 15, 2020

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 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)