Label: CALCIUM CARBONATE 1250 MG- calcium carbonate tablet

  • NDC Code(s): 70369-005-02, 70369-005-03
  • Packager: CitraGen Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 31, 2020

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  • Drug Facts

    Active ingredient (in each tablet)

    Calcium carbonate 1250 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 two tablets daily, or as directed by a doctor.
    • 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 500 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

  • PRINCIPAL DISPLAY PANEL

    CitraGen Pharmaceuticals, Inc.

    NDC: 70369-005-02

    Rev. 08/18 R-00

    Calcium Carbonate Tablets, USP 1250 mg

    ANTACID / Calcium Supplement

    500 Tablets

    THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    Bottle Label - 500 Count

  • PRINCIPAL DISPLAY PANEL

    CitraGen Pharmaceuticals, Inc.

    NDC: 70369-005-03

    Rev. 08/18 R-00

    Calcium Carbonate Tablets, USP 1250 mg

    ANTACID / Calcium Supplement

    100 Tablets

    Bottle Label - 100 Count

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE  1250 MG
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70369-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1250 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code CG005
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70369-005-02500 in 1 BOTTLE; Type 0: Not a Combination Product09/26/2018
    2NDC:70369-005-03100 in 1 BOTTLE; Type 0: Not a Combination Product09/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33109/26/2018
    Labeler - CitraGen Pharmaceuticals, Inc. (024949457)
    Registrant - CitraGen Pharmaceuticals, Inc. (024949457)
    Establishment
    NameAddressID/FEIBusiness Operations
    CitraGen Pharmaceuticals, Inc.024949457manufacture(70369-005)
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