Package Insert and Label Information: Sunmark Tropical Fruit

By McKesson | Last revised: 31 December 2011

SUNMARK TROPICAL FRUIT — calcium carbonate tablet, chewable
McKesson

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.

Active ingredient (in each tablet)

Calcium carbonate 750 mg

Purpose

Antacid

Uses

relieves

acid indigestion
heartburn

Warnings

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

do not take more than 10 tablets in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

Keep out of reach of children.

Directions

chew 2-4 tablets as symptoms occur, or as directed by a doctor.

Other information

do not use if printed seal under cap is torn or missing.
store at room temperature.

Inactive ingredients

corn starch, crospovidone, D and C red 27 lake, D and C yellow 10 lake, dextrose, FD and C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc

Principal Display Panel

sunmark

COMPARE TO TUMS^® E-X ACTIVE INGREDIENT

calcium antacid

Extra Strength

Fast relief of heartburn and acid indigestion

Daily source of calcium

TROPICAL FRUIT

96 CHEWABLE TABLETS

Tropical fruit antacid front label

(click image for full-size original)

Tropical fruit antacid back label

(click image for full-size original)

SUNMARK TROPICAL FRUIT
calcium antacid tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-956
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION)	CALCIUM CARBONATE	750 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN
CROSPOVIDONE
D&C RED NO. 27
D&C YELLOW NO. 10
DEXTROSE
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
MALTODEXTRIN
SUCROSE
TALC

Product Characteristics
Color	pink (Reddish pink) , orange, yellow, white	Score	no score
Shape	ROUND	Size	16mm
Flavor	FRUIT (bananna, orange, pineapple orange, punch)	Imprint Code	G127
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:49348-956-34	96 TABLET, CHEWABLE (TABLET) in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	10/10/2010

Labeler — McKesson (177667227)

Revised: 12/2011 McKesson