Label: CALCIUM CARBONATE 500 MG- calcium carbonate tablet, chewable

  • NDC Code(s): 69618-020-15
  • Packager: Reliable 1 Laboratories LLC
  • 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 23, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each chewable tablet)

    Calcium carbonate 500 mg

  • Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses relieves

    • acid indigestion
    • heartburn
    • sour stomach
  • Warnings

    Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

    Stop use and ask a doctor if symptoms last more than 2 weeks

    Keep out of reach of children.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

  • STOP USE

    Stop use and ask doctor if symptoms last more than 2 weeks

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Adults and children 12 years and over:

    • chew 2-4 tablets as symptoms occur
    • do not take more than 8 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks

    children under 12 years:

    ask a doctor

  • Other information

    • each tablet contains: calcium 200 mg
    • store at room temperature
  • Inactive ingredients

    Al-lakes (D&C red #27, D&C yellow #10, FD&C blue #1, FD&C yellow #6), dextrose, flavors, magnesium stearate, maltodextrin

  • Questions or comments?

    call 516-341-0666, 8:30 am - 4:30 pm ET, Monday-Friday

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-020-15 *Compare to Active Ingredient of Tums® Regular Strength

    ASSORTED FLAVORS

    Calcium Carbonate

    500 mg

    ANTACID

    150 CHEWABLE TABLETS

    *Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Tums®

    Calcium Carbonate 500 mg

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE 500 MG 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    Product Characteristics
    Colorblue (Light Blue) , orange (Light Orange) , yellow (Light Yellow) , purple (Light Purple) Scoreno score
    ShapeROUNDSize16mm
    FlavorORANGE (assorted fruit) Imprint Code AP;043
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-020-15150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/01/2015
    Labeler - Reliable 1 Laboratories LLC (079718111)