CALCIUM CARBONATE 500 MG (CALCIUM CARBONATE) TABLET, CHEWABLE [RELIABLE 1 LABORATORIES LLC]

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CALCIUM CARBONATE 500 MG (CALCIUM CARBONATE) TABLET, CHEWABLE [RELIABLE 1 LABORATORIES LLC]
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NDC 69618-020-15
Set ID 322f1b54-abe9-11a7-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Reliable 1 Laboratories LLC
Generic Name
Product Class
Product Number
Application Number PART331
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  • 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)
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