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

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

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!