Label: TITRALAC PLUS- calcium carbonate, dimethicone tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 55298-013-10 - Packager: iNova Pharmaceuticals Pty, Ltd
- 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
-
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
-
INGREDIENTS AND APPEARANCE
TITRALAC PLUS
calcium carbonate, dimethicone tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55298-013 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Calcium Carbonate (UNII: H0G9379FGK) (Calcium - UNII:SY7Q814VUP) Calcium Carbonate 420 mg dimethicone (UNII: 92RU3N3Y1O) (dimethicone - UNII:92RU3N3Y1O) dimethicone 21 mg Inactive Ingredients Ingredient Name Strength glycine (UNII: TE7660XO1C) magnesium stearate (UNII: 70097M6I30) saccharin (UNII: FST467XS7D) spearmint oil (UNII: C3M81465G5) starch, corn (UNII: O8232NY3SJ) Product Characteristics Color white (White) Score no score Shape ROUND (Round) Size 12mm Flavor SPEARMINT (SPEARMINT) Imprint Code TITRALAC;PLUS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55298-013-10 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 01/01/2004 Labeler - iNova Pharmaceuticals Pty, Ltd (750581035) Establishment Name Address ID/FEI Business Operations iNova Pharmaceuticals Pty, Ltd 750581035 MANUFACTURE