Your browser does not support JavaScript! STOMACH RELIEF LIQUID MAXIMUM STRENGTH (MAXIMUM STRENGTH PEPTO BISMOL) SUSPENSION [SUNMARK]
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STOMACH RELIEF LIQUID MAXIMUM STRENGTH (maximum strength pepto bismol) suspension
[Sunmark]


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 ingredients

Bismuth Subsalicylate 525 mg

Purpose

upset stomach
reliever-antidiarrheal

Uses

relieves, upset stomach, heartburn
indigestion, diarrhea, nausea

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 or 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- taking other salicylate products,

allergic to salicylates (including aspirin)

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 stool

Ask a doctor or pharmacist before use if you are taking any drug for

anticoagulation (thinning 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 this and all drugs out of the reach of children

In case of accidental overdose, seek professional
assistance or contact a Poison Control Center
immediately.

Directions

shake well before use
for accurate dosing, use dose cup
adults and children 12 years and over:
1 dose (2 tablespoons or 30 ml) every hour as needed

 do not exceed 4 doses
(8 tablespoons 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 tablespoon contains: sodium 6 mg
sugar free, low sodium, keep tightly closed
avoid excessive heat (over 104˚F or 40˚C)
protect from freezing.
Total salicylate per tablespoon, 236 mg
Visit www.peptic-drug-facts.com

Inactive ingredients

benzoic acid, flavor,
magnesium aluminum silicate, methyl cellulose, purified
water, red 22, red 28, saccharin sodium, salicylic acid,
sodium salicylate, sorbic acid

Principal Display Panel

COMPARE TO PEPTO BISMOL ACTIVE INGREDIENT

NDC 49348-923-37

STOMACH RELIEF LIQUID MAXIMUM STRENGTH

SOOTHING RELIEF FOR UPSET STOMACH

NAUSEA, INDIGESTION

HEARTBURN AND DIARRHEA

BISMUTH SUBSALICYLATE 525 mg

PROTECTIVE COATING ACTION

8 FL OZ (473 mL)

image of label

STOMACH RELIEF LIQUID  MAXIMUM STRENGTH
maximum strength pepto bismol suspension
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49348-923
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE525 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
MAGNESIUM ALUMINUM SILICATE 
METHYLCELLULOSE (100 CPS) 
SALICYLIC ACID 
SACCHARIN SODIUM 
SORBIC ACID 
D&C RED NO. 22 
D&C RED NO. 28 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-923-37237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33511/08/2013
Labeler - Sunmark (177667227)
Registrant - Aaron Industries, Inc. (101896231)
Establishment
NameAddressID/FEIBusiness Operations
Aaron Industries, Inc.101896231manufacture(49348-923), analysis(49348-923)

Revised: 11/2013
 
Sunmark

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