Your browser does not support JavaScript! STOMACH RELIEF (PEPTO BISMOL CHERRY) SUSPENSION [TOP CARE]
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STOMACH RELIEF (pepto bismol cherry) suspension
[Top Care]


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 262 mg

Purpose

Bismuth subsalicylate, 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

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 1/2 to 1 hour
as needed

do not exceed 8 doses
(16 tablespoons or 240 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

protect from freezing
each tablespoon contains- sodium 6 mg
sugar free, low sodium, keep tightly closed
store at controlled room temperature
avoid excessive heat (over 104˚F or 40˚C)
Total salicylate per tablespoon, 118 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, sucralose

Principal Display Panel

NDC 36800-136-07

REGULAR STRENGTH STOMACH RELIEF

BISMUTH SUBSALICYLATE 262 mg

UPSET STOMACH RELIEVER

ANTIDIARRHEAL

PROTECTIVE COATING ACTION

SOOTHING RELIEF FOR 5 SYMPTOMS

UPSET STOMACH

DIARRHEA, INDIGESTION

NAUSEA, HEARTBURN

CHERRY FLAVOR

COMPARE TO PEPTO BISMOL ACTIVE INGREDIENT

16 FL OZ (1 PT) 473 mL

image of label

STOMACH RELIEF 
pepto bismol cherry suspension
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-136
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Benzoic Acid 
Magnesium Aluminum Silicate 
Methylcellulose (100 CPS) 
Water 
SACCHARIN SODIUM ANHYDROUS 
Salicylic Acid 
Sodium Salicylate 
Sorbic Acid 
Sucralose 
D&C RED NO. 22 
D&C RED NO. 28 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Peptic Cherry Type Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-136-07473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33511/08/2013
Labeler - Top Care (006935977)
Registrant - Aaron Industries, Inc. (101896231)
Establishment
NameAddressID/FEIBusiness Operations
Aaron Industries, Inc.101896231manufacture(36800-136), analysis(36800-136)

Revised: 11/2013
 
Top Care

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