TITRALAC PLUS- calcium carbonate, dimethicone tablet 
iNova Pharmaceuticals Pty, Ltd

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.

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Drug Facts

Active ingredients

(in each tablet)

Calcium carbonate 420 mg

(168 mg elemental calcium)

Simethicone 21 mg

Purpose

Antacid

Antigas

Uses

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

Other information

Inactive ingredients

glycine, magnesium stearate, 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. 360-10

3M and Titralac are trademarks of 3M.

T7562

Principal Display Panel – Bottle Label

SPEARMINT FLAVOR

NDC 055298-013-10

FAST RELIEF

Titralac™

PLUS ANTACID

Simethicone Anti-Gas Formula

Calcium Rich • Sugar Free

Low Aluminum • Very Low Sodium

100 TABLETS 3M

Principal Display Panel – Bottle Label
TITRALAC PLUS 
calcium carbonate, dimethicone tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55298-013
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium Carbonate (UNII: H0G9379FGK) (Calcium - UNII:SY7Q814VUP) Calcium Carbonate420 mg
dimethicone (UNII: 92RU3N3Y1O) (dimethicone - UNII:92RU3N3Y1O) dimethicone21 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 TITRALAC;PLUS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55298-013-10100 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

Revised: 5/2011
Document Id: 8e9a93d6-f0ff-4ea5-bed9-688ab924aa85
Set id: 68725b83-46fc-47ae-bb5c-51f080dcacfe
Version: 1
Effective Time: 20110501
 
iNova Pharmaceuticals Pty, Ltd