topcare stomach relief ultra strength bismuth subsalicylate 525 mg drug facts

SPL v7

SPL

SPL Set ID e745e693-9e45-43b0-b26c-99ca891b74b0

Route

oral

Published

Effective Date 2025-11-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

salicylic acid (525 mg)

Inactive Ingredients

carboxymethylcellulose sodium, unspecified d&c red no. 22 d&c red no. 28 microcrystalline cellulose potassium hydroxide potassium sorbate water salicylic acid dimethicone, unspecified sodium benzoate sucralose xanthan gum

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

otc monograph drug active Since 2019-03-14

Purpose

Upset stomach reliever and antidiarrheal

Description

Bismuth subsalicylate 525 mg

Medication Information

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

Uses

relieves

travelers’ diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
heartburn
indigestion
nausea
gas
belching
fullness

Purpose

Upset stomach reliever and antidiarrheal

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

Description

Bismuth subsalicylate 525 mg

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

[email protected], www.topcarebrand.com

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

Package Label 354 mL

Purposes

Upset stomach reliever and antidiarrheal

Package Label 236 Ml

Do Not Use If You Have

an ulcer
a bleeding problem
bloody or black stool

Questions Or Comments?

1-888-423-0139

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

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).

Ask A Doctor Before Use If You Have

fever
mucus in the stool

Active Ingredient (in Each 15 Ml Dose)

Bismuth subsalicylate 525 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking any drug for

anticoagulation (thinning the blood)
diabetes
gout
arthritis

Structured Label Content

Warnings

Allergy alert: Contains salicylate. Do not take if you are

allergic to salicylates (including aspirin)
taking other salicylate products

Uses

relieves

travelers’ diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
heartburn
indigestion
nausea
gas
belching
fullness

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 (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 (Inactive ingredients)

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

QUESTIONS? 1-888-423-0139

[email protected], www.topcarebrand.com

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

Package Label 354 mL

Purposes

Upset stomach reliever and antidiarrheal

Package Label 236 Ml (Package Label 236 mL)

Do Not Use If You Have (Do not use if you have)

an ulcer
a bleeding problem
bloody or black stool

Questions Or Comments? (Questions or comments?)

1-888-423-0139

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

When Using This Product (When using this product)

a temporary, but harmless, darkening of the stool and/or tongue may occur.

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

fever
mucus in the stool

Active Ingredient (in Each 15 Ml Dose) (Active ingredient (in each 15 mL dose))

Bismuth subsalicylate 525 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any drug for

anticoagulation (thinning the blood)
diabetes
gout
arthritis

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness", "Purposes": "Upset stomach reliever and antidiarrheal", "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", "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", "Do not use if you have": "an ulcer a bleeding problem bloody or black stool", "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", "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).", "Ask a doctor before use if you have": "fever mucus in the stool", "Active ingredient (in each 15 mL dose)": "Bismuth subsalicylate 525 mg", "Ask a doctor or pharmacist before use if you are": "taking any drug for anticoagulation (thinning the blood) diabetes gout arthritis"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:15.492545 · Updated: 2026-03-14T23:13:34.159935