Label: TITRALAC- calcium carbonate tablet

  • 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 1, 2011

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  • Drug Facts

  • Active ingredients

    (in each tablet)

    Calcium carbonate 420 mg

    (168 mg elemental calcium)

  • Purpose

    Antacid

  • Uses

    relieves:

    • heartburn
    • sour stomach
    • acid indigestion
  • 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 for more than 2 weeks.

    Keep out of reach of children.

  • Directions

    • chew, swallow or let melt in mouth two tablets every two or three hours as symptoms occur or as directed by a physician
    • do not take more than 19 tablets in a 24 hour period or use maximum dosage for more than two weeks
  • Other information

    • sugar free
    • very low sodium content (0.5 mg/tablet)
    • low aluminum content (1.0 mg/tablet)
  • Inactive ingredients

    glycine, magnesium state, saccharin, spearmint oil, starch

    For your protection this bottle has a printed foil seal under the cap.

    For Information: 1-800-537-2191

    Made in Australia for 3M

    3M Consumer Health Care

    St. Paul, MN 55144-1000

    © 3M 2008 Cat. 355-10

    3M and Titralac are trademarks of 3M.

    T7567

  • Principal Display Panel – Bottle Label

    SPEARMINT FLAVOR

    NDC 055298-038-10

    FAST RELIEF

    Titralac™

    ANTACID

    Calcium Rich

    Sugar Free • Low Aluminum

    Very Low Sodium

    100 TABLETS 3M

    Principal Display Panel – Bottle Label
  • INGREDIENTS AND APPEARANCE
    TITRALAC 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55298-038
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Carbonate (UNII: H0G9379FGK) (Calcium - UNII:SY7Q814VUP) Calcium Carbonate420 mg
    Inactive Ingredients
    Ingredient NameStrength
    glycine (UNII: TE7660XO1C)  
    magnesium stearate (UNII: 70097M6I30)  
    saccharin (UNII: FST467XS7D)  
    spearmint oil (UNII: C3M81465G5)  
    starch, corn (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (White) Scoreno score
    ShapeROUND (Round) Size12mm
    FlavorSPEARMINT (SPEARMINT) Imprint Code 3M;TITRALAC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55298-038-10100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/01/2004
    Labeler - iNova Pharmaceuticals Pty, Ltd (750581035)
    Establishment
    NameAddressID/FEIBusiness Operations
    iNova Pharmaceuticals Pty, Ltd750581035MANUFACTURE
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