Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 0ab030be-e563-44df-9a7e-9e5fd6b87416
Route
ORAL
Published
Effective Date 2023-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (525 mg)
Inactive Ingredients
Benzoic Acid D&c Red No. 22 D&c Red No. 28 Magnesium Aluminum Silicate Water Saccharin Sodium Salicylic Acid Sodium Salicylate Sorbic Acid Methylcellulose (1500 Cps)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Completed Since 2019-02-28 Until 2025-10-30
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
    • nausea
    • gas
    • fullness
    • belching
Warnings

 Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms ahould 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
  • do not take more than 8 doses (120 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • mL = milliliter
  • shake well before using
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • adults and children 12 years and over:
    • 15 mL (1dose) every 1/2 or 30 mL (2 doses) every hour as needed diarrhea/traveler's diarrhea
    • 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) 
  • children under 12 years of age: ask a doctor



Do Not Use

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Package Label
Other Information
  • each 15 mL contains: sodium 6 mg
  • each 15 mL contains: salicylate 227 mg
  • low sodium
  • keep tightly closed
  • protect from freezing
  • avoid excessive heat (over 104ºF or 40ºC)
Inactive Ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN PEPTO-BISMOL® ULTRA*

ULTRA

Stomach Relief

Bismuth Subsalicylate 525 mg

Upset Stomach Reliever/Antidiarrheal

Soothing Relief For:

  • Upset Stomach
  • Indigestion
  • Heartburn
  • Diarrhea
  • Nausea

2x Strength Per Ounce†

Alcohol Free

Sugar Free

FL OZ (mL)

†This product is not manufactured or distributed by The Procter & Gamble Company. Pepto-Bismol® is a registered trademark of The Procter & Gamble Company.

TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

10611 MONROE RD.,

MATTHEWS, NC 28105

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
Keep Out of Reach of Childen.

In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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

  • diabetes
  • gout
  • arthritis
  • anticoagulation (thinning the blood)

Structured Label Content

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • fullness
    • 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 ahould 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
  • do not take more than 8 doses (120 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • mL = milliliter
  • shake well before using
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • adults and children 12 years and over:
    • 15 mL (1dose) every 1/2 or 30 mL (2 doses) every hour as needed diarrhea/traveler's diarrhea
    • 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) 
  • children under 12 years of age: ask a doctor



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 15 mL contains: sodium 6 mg
  • each 15 mL contains: salicylate 227 mg
  • low sodium
  • keep tightly closed
  • protect from freezing
  • avoid excessive heat (over 104ºF or 40ºC)
Inactive Ingredients (Inactive ingredients)

benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN PEPTO-BISMOL® ULTRA*

ULTRA

Stomach Relief

Bismuth Subsalicylate 525 mg

Upset Stomach Reliever/Antidiarrheal

Soothing Relief For:

  • Upset Stomach
  • Indigestion
  • Heartburn
  • Diarrhea
  • Nausea

2x Strength Per Ounce†

Alcohol Free

Sugar Free

FL OZ (mL)

†This product is not manufactured or distributed by The Procter & Gamble Company. Pepto-Bismol® is a registered trademark of The Procter & Gamble Company.

TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

10611 MONROE RD.,

MATTHEWS, NC 28105

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
Keep Out of Reach of Childen. (Keep out of reach of childen.)

In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

  • diabetes
  • gout
  • arthritis
  • anticoagulation (thinning the blood)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:30.733350 · Updated: 2026-03-14T23:00:57.322924