TOPCARE STOMACH RELIEF ULTRA STRENGTH- bismuth subsalicylate suspension 
TOPCO ASSOCIATES LLC

----------

TopCare Stomach Relief Ultra Strength Bismuth Subsalicylate 525 mg Drug Facts

Active ingredient (in each 15 mL dose)

Bismuth subsalicylate 525 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 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

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 or last more than 2 days
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 at (1-800-222-1222).

Directions

shake well before use
Only use dose cup provided
adults and children 12 years and over: 15 mL (1 dose) every 1/2 or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea.
15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
do not exceed 8 doses (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 15 mL contains: sodium 10 mg
salicylate 230 mg
low sodium
sugar free
store at room temperature
protect from freezing
avoid excessive heat (over than 104°F or 40°C)

Inactive ingredients

carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum

Questions or comments?

1-888-423-0139

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN.

Principal Display Panel

TopCare® health

COMPARE TO PEPTO-BISMOL® ULTRA STRENGTH ACTIVE INGREDIENT*

ULTRA STRENGTH

Stomach Relief

BISMUTH SUBSALICYLATE 525 mg per 15 mL

UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5 SYSMPTOM DIGESTIVE RELIEF

Heartburn
Indigestion
Upset Stomach
Nausea
Diarrhea

OUR PHARMACISTS RECOMMEND

QUALITY GURANTEED

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO RARA0919

QUESTIONS? 1-888-423-0139

topcare@topco.com, www.topcarebrand.com

*This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol®.

Package Label 354 mL

TopCare Ultra Strength Stomach 354 mL doses

Package Label 236 mL

TopCare Ultra Strength Stomach 236 mL doses
TOPCARE STOMACH RELIEF  ULTRA STRENGTH
bismuth subsalicylate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-341
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPINK (viscous) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-341-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/2019
2NDC:36800-341-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00803/14/2019
Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 11/2023
Document Id: 6c47a159-a1ee-4c91-9270-331e1e82bfa4
Set id: e745e693-9e45-43b0-b26c-99ca891b74b0
Version: 5
Effective Time: 20231120
 
TOPCO ASSOCIATES LLC