TITRALAC- calcium carbonate tablet

Titralac by

Drug Labeling and Warnings

Titralac by is a Otc medication manufactured, distributed, or labeled by iNova Pharmaceuticals Pty, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TITRALAC 
calcium carbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55298-038
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

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	3M;TITRALAC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55298-038-10	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