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TITRALAC PLUS (calcium carbonate, dimethicone) tablet
[iNova Pharmaceuticals Pty, Ltd]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Drug Facts

Active ingredients

(in each tablet)

Calcium carbonate 420 mg

(168 mg elemental calcium)

Simethicone 21 mg

Purpose

Antacid

Antigas

Uses

  • relieves symptoms referred to as gas
  • 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 (1.5 mg/tablet)
  • low aluminum content (1.0 mg/tablet)

Inactive ingredients

glycine, magnesium stearate, saccharin, spearmint oil, starch

  • may also contain croscarmellose sodium

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

INGREDIENTS & APPEARANCE

TITRALAC PLUS 
calcium carbonate, dimethicone tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55298-013
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium Carbonate (Calcium) Calcium Carbonate420 mg
dimethicone (dimethicone) dimethicone21 mg
Inactive Ingredients
Ingredient NameStrength
glycine 
magnesium stearate 
saccharin 
spearmint oil 
starch, corn 
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
 
iNova Pharmaceuticals Pty, Ltd