EQUALINE STOMACH RELIEF- bismuth subsalicylate suspension 
Supervalu Inc

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.

----------

SuperValu Inc. Stomach Relief Drug Facts

Active ingredient (in each 30 mL dose cup)

Bismuth subsalicylate 1050 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

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

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 hour as needed
do not exceed 4 doses (120 mL or 8 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 461 mg
low sodium
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, magnesium aluminum silicate, methyl salicylate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum

Questions or comments?

1-877-932-7948

Principal Display Panel

compare to Pepto-Bismol® Max Strength active ingredient

maximum strength

stomach relief liquid

bismuth subsalicylate

1050mg per 30mL

(upset stomach reliever/anti-diarrheal)

5 symptom digestive relief

heartburn

indigestion

nausea

upset stomach

diarrhea

8 FL OZ (237mL)

Equaline Stomach Relief Liquid Image
EQUALINE STOMACH RELIEF 
bismuth subsalicylate suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-600
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 1050 mg  in 30 mL
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color PINK (viscous) Score     
Shape Size
Flavor WINTERGREEN Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41163-600-34 237 mL in 1 BOTTLE
2 NDC:41163-600-40 355 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part335 10/07/2004
Labeler - Supervalu Inc (006961411)

Revised: 12/2014
Document Id: 02b19c0e-f62a-4d48-a41c-a6d820591e0d
Set id: 50f99895-8fd0-48c2-be5e-8fdb9c7e506d
Version: 3
Effective Time: 20141219
 
Supervalu Inc