MAXIMUM STRENGTH- bismuth subsalicylate liquid 
Publix Super Markets 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.

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Publix Super Markets, Inc. Maximum Strength Pink Bismuth Liquid Drug Facts

Active ingredient (in each 15 mL Tablespoon)

Bismuth subsalicylate 525 mg

Purpose

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

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
•
for accurate dosing, use dose cup
•
adults and children 12 years and over: 1 dose (2 Tbsp or 30 mL) every hour as needed
•
do not exceed 4 doses (8 Tbsp or 120 mL) 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 Tbsp contains: magnesium 5 mg, potassium 5 mg and sodium 5 mg
•
salicylate 231 mg
•
low sodium
•
sugar free
•
protect from freezing
•
store at 20-25°C (68-77°F)
•
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

Principal Display Panel

STOMACH RELIEF

maximum strength

PINK BISMUTH LIQUID

BISMUTH SUBSALICYLATE 525mg

ANTIDIARRHEAL

UPSET STOMACH RELIEVER

Soothing relief for:

upset stomach

diarrhea

heartburn

indigestion

nausea

Compare to Active Ingredient in Pepto-Bismol® Max Strength

Maximum Strength Label

Maximum Strength Label

Maximum Strength Label

MAXIMUM STRENGTH 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-337
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE525 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
XANTHAN GUM (UNII: TTV12P4NEE)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
Product Characteristics
ColorPINK (viscous) Score    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-337-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product08/08/200205/26/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33508/08/200205/26/2013
Labeler - Publix Super Markets Inc (006922009)

Revised: 11/2017
Document Id: 3e543612-72d4-4d25-93ab-f1f844c62e6b
Set id: d6ac330e-a336-4071-b31c-f27a99eb45cf
Version: 3
Effective Time: 20171127
 
Publix Super Markets Inc