Your browser does not support JavaScript! STOMACH RELIEF (BISMUTH SUBSALICYLATE) SUSPENSION [SHOPKO STORES OPERATING CO., LLC]
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STOMACH RELIEF (bismuth subsalicylate) suspension
[Shopko Stores Operating Co., LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Active ingredient (in each 30 mL dose cup)

Bismuth subsalicylate 525 mg

Purposes

Upset stomach reliever and antidiarrheal

Uses

relieves

travelers’ diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
heartburn
indigestion
nausea
gas
belching
fullness

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 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. (1-800-222-1222)

Directions

shake well before use
use dose cup
adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour as needed
do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours
use until diarrhea stops but not more than 2 days
children under 12 years: ask a doctor
drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

each 30 mL dose cup contains: magnesium 15 mg, potassium 5 mg and sodium 12 mg
salicylate 254 mg
low sodium
store at 20-25°C (68-77°F)
protect from freezing
does not meet USP requirements for pH
for health information visit www.more-info.info

Inactive ingredients

D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Pepto-Bismol® Active Ingredient

Regular Strength

Stomach Relief

Bismuth Subsalicylate 525 mg per 30 mL

Upset Stomach Reliever/Antidiarrheal

Soothing Relief For:

Indigestion

Upset Stomach

Nausea

Heartburn

Diarrhea

Original Flavor

12 FL OZ (354 mL)

Stomach Relief
STOMACH RELIEF 
bismuth subsalicylate suspension
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37012-302
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (BISMUTH CATION and SALICYLIC ACID) BISMUTH SUBSALICYLATE525 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 22 
D&C RED NO. 28 
MAGNESIUM ALUMINUM SILICATE 
WATER 
SACCHARIN SODIUM 
SALICYLIC ACID 
SODIUM SALICYLATE 
SORBIC ACID 
XANTHAN GUM 
METHYL SALICYLATE 
Product Characteristics
ColorPINK (viscous) Score    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37012-302-40354 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33511/14/2013
Labeler - Shopko Stores Operating Co., LLC (023252638)

Revised: 6/2014
 
Shopko Stores Operating Co., LLC

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