Active Ingredient (in each tablet)

Bismuth subsalicylate 262mg

Purposes

Anti-diarrheal/ Upset stomach reliever

Uses

controls diarrhea
relieves upset stomach due to overindulgence in food or drink

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 symtoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Do not take if you are

allergic to salicylates (including aspirin)
taking other salicylate products

Do not use

if you have bloody or black stool
if you have an ulcer or bleeding problem

Ask a doctor before use if you have

fever
mucus in the stool

Ask a doctor or pharmacist before use if you are

talking any drug for

anticoagulation (thinning the blood)
diabetes
gout
arthritis

When using this product

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

Stop use and ask a doctor if

symptoms get worse
ringing in 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

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
repeat dosage every 1/2 to 1 hour as needed
do not take more than 8 doses in 24 hours
use untill diarrhea stops but not more than 2 days
adults and children 12 years and over: 2 tablets
children under 12 years: ask a doctor

Other information

each tablet contains: calcium 77 mg, salicylate 102 mg
store at 15 to 300C (59 to 860F)
protect from moisture

Inactive ingredients

calcium carbonate, D&C red #27(Al-lake), dextrose, flavor(cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions or comments?

Adverse drug event call 1-(714)-903-7952

Principal Display Panel

NDC 66424-045-30

Stomach Relief

Bismuth Subsalicylate 262 mg

Anti-Diarrheal/ Upset Stomach Reliever

Helps to Relieve:

Upset Stomach
Diarrhea
Indigestion
Heartburn
Nausea

†Compare to the Active Ingredients in Pepto-Bismol

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark Pepto-Bismol

Stomach Relief label

STOMACH RELIEF
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66424-045
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	pink (light)	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	AP;045
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66424-045-30	30 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	09/27/2012

Labeler - SDA Laboratories, Inc. (948067889)

Drug Facts