CALCIUM CARBONATE TABLET [CARILION MATERIALS MANAGEMENT]

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CALCIUM CARBONATE TABLET [CARILION MATERIALS MANAGEMENT]
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NDC 68151-0012-1
Set ID 1cd621d0-58b9-45f7-80fb-e13ca68596a1
Category HUMAN OTC DRUG LABEL
Packager Carilion Materials Management
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active Ingredient

    (in each tablet)

    Calcium carbonate 10 gr (648 mg)

  • Purpose

    Antacid

  • Use

    relieves

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

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

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

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

    Keep out of reach of children.

  • Directions

    • take one to four tablets daily
    • do not take more than 4 tablets in 24 hours
    • do not use the maximum 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 sterate, maltodextrin, microcrystalline cellulose, stearic acid

  • Questions or Comments

    Call Monday – Friday, 9 am – 5 pm ET 1-800-645-2158,

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

    This is a bulk pakage, dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

    Mfd for: Rugby Laboratories,Inc

  • CALCIUM CARBONATE TABLET

    Label Image
  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE  
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68151-0012(NDC:0536-3414)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE648 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITE (off white) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AP;025
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68151-0012-11 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/12/1999
    Labeler - Carilion Materials Management (079239644)
    Registrant - Carilion Materials Management (079239644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Carilion Materials Management079239644REPACK(68151-0012)
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