BISMUTH TABS - bismuth subsalicylate tablet, chewable
DOLGENCORP, LLC

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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Active ingredients

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever/Antidiarrheal

Uses

relieves:

heartburn
indigestion
upset stomach
nausea
diarrhea

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Contains salicylate. Do not take if you are:

allergic to salicylates (including aspirin)
taking other salicylate products

Do not use

if you have

an ulcer
a bleeding problem
bloody or black stool

Ask a doctor before use if you have

fever
mucus in the stool

Ask a doctor or pharmacist before use if you are

taking any drug for

anticoagulation (thinning of the blood)
diabetes
gout
arthritis

When using this product

a temporary, but harmless, darkening of the stool and/or tongue my occur.

Stop use and ask a doctor if

symptoms get worse
ringing of the ears or loss of hearing occurs
diarrhea lasts more than 2 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

chew or dissolve in mouth
drink plenty of clear fluids to help prevent dehydration caused by diarrhea
adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed. Do not exceed 8 doses (16 tablets) in 24 hours.
use until diarrhea stops, but not more than 2 days
children under 12 years: ask a doctor

Other information

each tablet contains: calcium 40 mg, salicylate 102 mg
store at controlled room temperature 15º-30ºC (59º-86ºF)
avoid excessive heat
store in a dry place
see end flap for expiration date and lot number

Inactive ingredients

calcium carbonate, cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, mannitol, povidone, sodium saccharin, stearic acid, talc

Principal Display Panel

Since 1903

Rexall®

Bismuth Tabs

Bismuth subsalicylate 262 mg

• Relieves indigestion

• Upset stomach

• Diarrhea

• Heartburn

• Nausea

Chewable Tablets

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF CELLOPHANE UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

MANUFACTURED FOR DOLGENCORP, LLC

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA

GDRX 319

BISMUTH TABS
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-756
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (BISMUTH)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE
D&C RED NO. 27
D&C RED NO. 30
MAGNESIUM STEARATE
MANNITOL
POVIDONE
SACCHARIN SODIUM
STEARIC ACID
TALC

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	44;319
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:55910-756-01	1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
1		30 TABLET, CHEWABLE (30 TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (55910-756-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part335	07/16/1998

Labeler - DOLGENCORP, LLC (068331990)

Revised: 07/2011 DOLGENCORP, LLC