Quality Choice Stomach Relief Regular Strength Bismuth Subsalicylate 525 Mg

SPL v6

SPL

SPL Set ID d019eef1-8817-4bd4-84cf-04fd6542ee1a

Route

ORAL

Published

Effective Date 2019-04-25

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 2019-04-15

Description

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and antidiarrheal

Medication Information

Purpose

Upset stomach reliever and antidiarrheal

Description

Bismuth subsalicylate 525 mg

Uses

relieves

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

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
for accurate dosing, use dose cup
adults and children 12 years and over:1 dose (30 mL) every 1/2 to 1 hour as needed
do not exceed 8 doses (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

each 30 mL contains:sodium 10 mg
salicylate 261 mg
low sodium
sugar free
store at room temperature
protect from freezing
avoid excessive heat (more than 104°F 40°C)

Inactive Ingredients

carboxymethylcellulose sodium, D&C Red # 22, D&C Red # 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?

1-866-467-2748

Do not use if imprinted shrink band is missing or broken.

Principal Display Panel

Quality Choice®

NDC# 63868-305-08

Compare To the Active Ingredient PEPTO-BISMOL® Regular Strength

Pink Bismuth

Stomach Relief

Bismuth Subsalicylate 525 mg

Soothing Relief from:

Upset Stomach

Indigestion

Nausea

Heartburn

Diarrhea

Regular Strength

Cherry Flavor

8 FL. OZ. (236 mL)

100% QC SATISFACTION GURANTEE

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

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

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 (1-800-222-1222).

Ask A Doctor Before Use If You Have

fever
mucus in the stool

Active Ingredient (in Each 30 Ml Dose Cup)

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

Uses

relieves

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

Purposes

Upset stomach reliever and antidiarrheal

Warnings

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

allergic to salicylates (including aspirin)
taking other salicylate products

Directions

shake well before use
for accurate dosing, use dose cup
adults and children 12 years and over:1 dose (30 mL) every 1/2 to 1 hour as needed
do not exceed 8 doses (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 (Other information)

each 30 mL contains:sodium 10 mg
salicylate 261 mg
low sodium
sugar free
store at room temperature
protect from freezing
avoid excessive heat (more than 104°F 40°C)

Inactive Ingredients (Inactive ingredients)

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?)

1-866-467-2748

Do not use if imprinted shrink band is missing or broken.

Principal Display Panel

Quality Choice®

NDC# 63868-305-08

Compare To the Active Ingredient PEPTO-BISMOL® Regular Strength

Pink Bismuth

Stomach Relief

Bismuth Subsalicylate 525 mg

Soothing Relief from:

Upset Stomach

Indigestion

Nausea

Heartburn

Diarrhea

Regular Strength

Cherry Flavor

8 FL. OZ. (236 mL)

100% QC SATISFACTION GURANTEE

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

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

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 (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 30 Ml Dose Cup) (Active ingredient (in each 30 mL dose cup))

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", "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 for accurate dosing, use dose cup adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed do not exceed 8 doses (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": "each 30 mL contains: sodium 10 mg salicylate 261 mg low sodium sugar free store at room temperature protect from freezing avoid excessive heat (more than 104°F 40°C)", "Inactive ingredients": "carboxymethylcellulose sodium, D&C Red # 22, D&C Red # 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?": "1-866-467-2748 Do not use if imprinted shrink band is missing or broken.", "Principal Display Panel": "Quality Choice® NDC# 63868-305-08 Compare To the Active Ingredient PEPTO-BISMOL® Regular Strength Pink Bismuth Stomach Relief Bismuth Subsalicylate 525 mg Soothing Relief from: Upset Stomach Indigestion Nausea Heartburn Diarrhea Regular Strength Cherry Flavor 8 FL. OZ. (236 mL) 100% QC SATISFACTION GURANTEE Distributed by C.D.M.A., Inc.© 43157 W 9 Mile Rd Novi, MI 48375 www.qualitychoice.com Questions: 248-449-9300 *This product is not manufactured or distributed by The Procter & Gamble, distributor of Pepto-Bismol ® .", "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 (1-800-222-1222).", "Ask a doctor before use if you have": "fever mucus in the stool", "Active ingredient (in each 30 mL dose cup)": "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: 2026-02-15T12:07:29.026589 · Updated: 2026-03-14T23:11:00.469021