CALSIUM CARBONATE 10 GR (CALCIUM CARBONATE) TABLET [RELIABLE 1 LABORATORIES LLC]

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CALSIUM CARBONATE 10 GR (CALCIUM CARBONATE) TABLET [RELIABLE 1 LABORATORIES LLC]
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NDC 69618-021-10
Set ID 32bc07dc-7a94-63ed-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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  • Drug Facts

  • Active ingredient (in each tablet)

    Calcium carbonate 10 gr

  • Purpose

    Antacid

  • Uses

    relieves

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
  • 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.

    If pregnant or breast-feeding, ask a health professional before use.

    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 a doctor if symptoms last more than 2 weeks.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Directions

    • take one to four tablets daily
    • do not take more than 4 tablets in 23 hours
    • do not use the maximun dosage for more than 2 weeks
  • Other information

    • each tablet contains: calcium 260 mg
    • store at room temperature 15°-30°C (59°-86°F)
  • Inactive ingredients

    croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

  • Question or comments?

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

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • SPL UNCLASSIFIED SECTION

    Distributed by: Reliable 1 Laboratories LLC

    Valley Stream, NY 11580

    www.reliable1labs.com

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-021-10

    Calcium Carbonate 10 gr

    ANTACID

    1000 TABLETS

    CALCIUM CARBONATE

  • INGREDIENTS AND APPEARANCE
    CALSIUM CARBONATE 10 GR 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE648 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AP;025
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-021-101000 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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