CALCIUM CARBONATE (ANTACID) (CALCIUM CARBONATE) TABLET [PHARBEST PHARMACEUTICALS INC.]

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CALCIUM CARBONATE (ANTACID) (CALCIUM CARBONATE) TABLET [PHARBEST PHARMACEUTICALS INC.]
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NDC 16103-377-08, 16103-377-11
Set ID 98041570-993e-4ab4-8565-1f8c0b5e433a
Category HUMAN OTC DRUG LABEL
Packager Pharbest Pharmaceuticals Inc.
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active ingredient (in each tablet)

    Calcium carbonate 10 gr (648 mg, USP)

  • Purpose

    Antacid

  • Uses

    for relief of

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


    Ask a doctor before use if you have

    • kidney stone
    • a calcium-restricted diet

    Ask a doctor or pharmacist before use if

    you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this prouct

    • do not take more than 10 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks

    Keep out of the reach of children.


  • Direction

    • take two to four tablets as symptoms occur or as directed by a doctor
  • Other information

    • each tablet contains: calcium 240 mg
    • store at controlled room temperature 150 to 300C (590 to 860F)
    • use by expiration date on package
  • Inactive ingredients

    croscarmellose sodium, magnesium stearate, microcrystalline cellulose, stearic acid

  • Questions? Adverse drug event call:

    (866) 562-2756

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 16103-0377-11

    Manufactured in the U.S.A.

    †Compare to Tums® active ingredient

    Calcium

    Carbonate

    Antacid

    Calcium Rich •Low Sodium Antacid

    THIS PACKAGE FOR HOUSEHOLDS

    WITHOUT YOUNG CHILDREN

    1000 TABLETS

    10 gr (648 mg)

    Calcium Carbonate 648mg Product Label

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE   (ANTACID)
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-377
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE648 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code PH046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-377-08100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/29/2006
    2NDC:16103-377-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/29/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/29/2006
    Labeler - Pharbest Pharmaceuticals Inc. (557054835)
    Registrant - Pharbest Pharmaceuticals Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals Inc.557054835analysis(16103-377) , manufacture(16103-377) , pack(16103-377) , label(16103-377)
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