CALCIUM CARBONATE 10 GR (648 MG) (CALCIUM CARBONATE) TABLET [CITRAGEN PHARMACEUTICALS, INC.]

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CALCIUM CARBONATE 10 GR (648 MG) (CALCIUM CARBONATE) TABLET [CITRAGEN PHARMACEUTICALS, INC.]
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NDC 70369-004-01
Set ID 723b940d-4f4b-f2e6-e053-2991aa0a8bcc
Category HUMAN OTC DRUG LABEL
Packager CitraGen Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number PART331
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  • Drug Facts

    Active ingredient (in each tablet)

    Calcium carbonate 10 gr (648 mg)

  • Purpose

    Antacid / Calcium Supplement

  • 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.

  • 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 15º - 30º C (59º - 86º F)

  • Inactive ingredients

    Hydrogenated Vegetable Oil, Maltodextrin and Microcrystalline Cellulose

  • Questions or comments?

    Phone: +1-510-249-9066 (9AM-5PM PST, Mon-Fri); e-mail: info@citragenpharma.com

  • SPL UNCLASSIFIED SECTION

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

    Manufactured by:
    CitraGen Pharmaceuticals, Inc.,
    Fremont, CA 94538.

    www.citragenpharma.com

    Rev. 07/18 R-00

  • PRINCIPAL DISPLAY PANEL

    CitraGen Pharmaceuticals, Inc.

    NDC: 70369-004-01

    Calcium Carbonate Tablets, USP 10 gr (648 mg)

    ANTACID / Calcium Supplement

    1000 Tablets

    THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    70369-004-01_Bottle_Label

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE  10 GR (648 MG)
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70369-004
    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
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code CG004
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70369-004-011000 in 1 BOTTLE; Type 0: Not a Combination Product08/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/07/2018
    Labeler - CitraGen Pharmaceuticals, Inc. (024949457)
    Registrant - CitraGen Pharmaceuticals, Inc. (024949457)
    Establishment
    NameAddressID/FEIBusiness Operations
    CitraGen Pharmaceuticals, Inc.024949457manufacture(70369-004)
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