Label: HEALTHY MAMA TAME THE FLAME- calcium carbonate tablet, chewable

  • 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 May 31, 2013

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

View All Sections
  • Active ingredient (in each tablet)

    Calcium Carbonate 500 mg

         (200 mg. of elemental calcium)


  • Purposes

    Antacid

  • Uses

    relieves



    • acid indigestion
    • heartburn
    • sour stomach
  • Warnings

    Ask a doctor or pharmacist before use if you are, taking a prescription drug. Antacids may interact with certain prescription drugs.


    • do not take more than 16 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks

    Keep out of reach of children. In case of accidental overdose, seek professional help or contact a poison control center immediately.

  • Directions

    • chew 2-4 tablets as symptoms occur
    • repeat hourly if symptoms return

  • Other information


    • Store at room temperature, USP.
    • each tablet contains 200 mg. of calcium
  • Inactive ingredients

    Acacia, Colloidal Silica, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Natural and Artificial Spearmint Flavor, Starch, Sucrose


  • Questions or comments?

    Call xxxxxxxxxx, 9 am- 5 pm EST


  • Principal Display Panel

    healthy

    mama

    TAME THE FLAME!

    antacid calcium supplement

    CALCIUM RICH

    assorted fruit flavor

    150 chewable tabletsUntitled.jpg

  • INGREDIENTS AND APPEARANCE
    HEALTHY MAMA  TAME THE FLAME
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58154-103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ACACIA (UNII: 5C5403N26O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (Capsule shaped tablet) Size16mm
    FlavorMINTImprint Code GPI;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58154-103-01150 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33105/31/2013
    Labeler - MATERNAL SCIENCE, LLC (078722406)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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