TOPCARE STOMACH RELIEF ORIGINAL STRENGTH- bismuth subsalicylate tablet, chewable 
Topco Associates LLC

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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Topco Associates LLC. Stomach Relief Drug Facts

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever/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
kidney stones
a calcium-restricted diet

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

chew or dissolve tablets in mouth
drink plenty of clear fluids to help prevent dehydration caused by diarrhea
adults and children 12 years and over: 2 tablets every ½ to 1 hour, or 4 tablets every hour as needed
do not exceed 16 tablets in 24 hours
use until diarrhea stops but not more than 2 days
children under 12 years: ask a doctor

Other information

each tablet contains: calcium 265 mg and salicylate 99 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

calcium carbonate, D&C red #27 aluminum lake, FD&C blue #1 aluminum lake, flavor, magnesium stearate, mannitol, saccharin sodium

Questions?

1-888-423-0139

Principal Display Panel

ORIGINAL STRENGTH

Stomach Relief

Chewables

BISMUTH SUBSALICYLATE 262 mg

UPSET STOMACH RELIEVER

ANTIDIARRHEAL

Protective Coating Action

Soothing Relief for 5 Symptoms:

Heartburn

Indigestion

Upset Stomach

Nausea

Diarrhea

actual size

COMPARE TO PEPTO-BISMOL® active ingredient

Stomach Relief Carton Image 1

Stomach Relief Carton Image 1

Stomach Relief Carton Image 2

Stomach Relief Carton Image 1

Stomach Relief Carton Image 2

TOPCARE STOMACH RELIEF  ORIGINAL STRENGTH
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-469
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize17mm
FlavorImprint Code L469
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-469-655 in 1 CARTON09/17/199106/01/2012
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33509/17/199106/01/2012
Labeler - Topco Associates LLC (006935977)

Revised: 11/2017
 
Topco Associates LLC