Quality Choice Max Strength Bismuth Subsalicylate 525mg

SPL v6

SPL

SPL Set ID 63f191f1-b29f-4842-9d80-ac43117c2361

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 Microcrystalline Cellulose Potassium Hydroxide Potassium Sorbate Water D&c Red No. 22 D&c Red No. 28 Salicylic Acid Dimethicone, Unspecified Sodium Benzoate Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-04-16

Description

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/Antidiarrheal

Medication Information

Purpose

Upset stomach reliever/Antidiarrheal

Description

Bismuth subsalicylate 525 mg

Uses

relieves

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

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

Directions

shake well before use
For accurate dosing, use dose cup
adults and children 12 years and over:
- 1 dose (2 tbsp. or 30 ml) every 1 hour as needed
- do not exceed 4 doses (8tbsp or 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

Do Not Use

if you have

an ulcer
a bleeding problem
bloody or black stool

Package Label

Other Information

each tbsp. contains:sodium 10 mg
low sodium
sugar free
salicylate 236 mg
protect from freezing
avoid excessive heat (more than 104ºF or 40ºC)
TAMPER EVIDENT: Do not use if imprinted shrink band is missing or broken

Inactive Ingredients

Carboxymethylcellulose sodium, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, red 22, red 28, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum.

Principal Display Panel

Compare to the active ingredient in Pepto-Bismol® Maximum Strength

Pink Bismuth

Maximum Strength

Stomach Relief

Bismuth Subsalicylate 525 mg

Soothing Relief from:

Upset Stomach

Indigestion Nausea

Heartburn

Diarrhea

Original Flavor

FL OZ (mL)

QC SATISFACTION GURANTEED

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

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

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)

Active Ingredient (in Each 15 Ml)

Bismuth subsalicylate 525 mg

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

Structured Label Content

Uses

relieves

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

Purpose

Upset stomach reliever/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 (2 tbsp. or 30 ml) every 1 hour as needed
- do not exceed 4 doses (8tbsp or 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

Do Not Use (Do not use)

if you have

an ulcer
a bleeding problem
bloody or black stool

Package Label

Other Information (Other information)

each tbsp. contains:sodium 10 mg
low sodium
sugar free
salicylate 236 mg
protect from freezing
avoid excessive heat (more than 104ºF or 40ºC)
TAMPER EVIDENT: Do not use if imprinted shrink band is missing or broken

Inactive Ingredients (Inactive ingredients)

Principal Display Panel

Compare to the active ingredient in Pepto-Bismol® Maximum Strength

Pink Bismuth

Maximum Strength

Stomach Relief

Bismuth Subsalicylate 525 mg

Soothing Relief from:

Upset Stomach

Indigestion Nausea

Heartburn

Diarrhea

Original Flavor

FL OZ (mL)

QC SATISFACTION GURANTEED

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

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

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
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)

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

Bismuth subsalicylate 525 mg

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

fever
mucus in the stool

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 upset stomach nausea gas belching", "Purpose": "Upset stomach reliever/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 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", "Directions": "shake well before use For accurate dosing, use dose cup adults and children 12 years and over: 1 dose (2 tbsp. or 30 ml) every 1 hour as needed do not exceed 4 doses (8tbsp or 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", "Do not use": "if you have an ulcer a bleeding problem bloody or black stool", "Other information": "each tbsp. contains: sodium 10 mg low sodium sugar free salicylate 236 mg protect from freezing avoid excessive heat (more than 104ºF or 40ºC) TAMPER EVIDENT: Do not use if imprinted shrink band is missing or broken", "Inactive ingredients": "Carboxymethylcellulose sodium, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, red 22, red 28, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum.", "Principal Display Panel": "Compare to the active ingredient in Pepto-Bismol® Maximum Strength Pink Bismuth Maximum Strength Stomach Relief Bismuth Subsalicylate 525 mg Soothing Relief from: Upset Stomach Indigestion Nausea Heartburn Diarrhea Original Flavor FL OZ (mL) QC SATISFACTION GURANTEED *This product is not manufactured or distributed by The Procter & Gamble, distributors of Pepto-Bismol ® . Distributed by C.D.M.A., Inc. 43157 W. Nine Mile Novi, MI 48376-0995 www.qualitychoice.com Questions: 248-449-9300", "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)", "Active ingredient (in each 15 mL)": "Bismuth subsalicylate 525 mg", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:28.182122 · Updated: 2026-03-14T23:10:57.415546