Label: CALCIUM CARBONATE 10 GR (648 MG)- calcium carbonate tablet

  • NDC Code(s): 70369-004-01
  • 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 August 7, 2018

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active ingredient (in each tablet)

    Calcium carbonate 10 gr (648 mg)

    Close
  • Purpose

    Antacid / Calcium Supplement

    Close
  • Uses

    relieves:

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

    Close
  • 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
    Close
  • Other information

    each tablet contains: Calcium 260 mg

    store at room temperature 15º - 30º C (59º - 86º F)

    Close
  • Inactive ingredients

    Hydrogenated Vegetable Oil, Maltodextrin and Microcrystalline Cellulose

    Close
  • Questions or comments?

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

    Close
  • 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

    Close
  • 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

    Close
  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE  10 GR (648 MG)
    calcium carbonate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70369-004
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 648 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code CG004
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70369-004-01 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/07/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 08/07/2018
    Labeler - CitraGen Pharmaceuticals, Inc. (024949457)
    Registrant - CitraGen Pharmaceuticals, Inc. (024949457)
    Establishment
    Name Address ID/FEI Business Operations
    CitraGen Pharmaceuticals, Inc. 024949457 manufacture(70369-004)
    Close