Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID 5f7a0905-344b-40e1-8b32-171dabb560b3

Route

ORAL

Published

Effective Date 2024-09-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Salicylic Acid (525 mg)

Inactive Ingredients

Benzoic Acid D&c Red No. 22 D&c Red No. 28 Glycerin Water Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-02-25

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

LEADER Ultra Stomach Relief

Other Information

each 15 mL contains: sodium 5 mg
each 15 mL contains: salicylate 206 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, glycerin, purified water, sucralose, xanthan gum

Questions Or Comments?

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

Principal Display Panel

COMPARE TO PEPTO-BISMOL® ULTRA active ingredient*

Ultra

Stomach Relief

Bismuth Subsalicylate 525 mg per 15 mL

Upset Stomach Reliever / Antidiarrheal

Relieves

Heartburn
Indigestion
Nausea

Upset Stomach

Diarrhea

2x Strength per Ounce^†

†vs. Original Pepto-Bismol®

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 CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

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

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

LEADER Ultra Stomach Relief

Other Information (Other information)

each 15 mL contains: sodium 5 mg
each 15 mL contains: salicylate 206 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, glycerin, purified water, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

COMPARE TO PEPTO-BISMOL® ULTRA active ingredient*

Ultra

Stomach Relief

Bismuth Subsalicylate 525 mg per 15 mL

Upset Stomach Reliever / Antidiarrheal

Relieves

Heartburn
Indigestion
Nausea

Upset Stomach

Diarrhea

2x Strength per Ounce^†

†vs. Original Pepto-Bismol®

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 CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

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

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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 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": "if you have an ulcer a bleeding problem bloody or black stool", "Package Label": "LEADER Ultra Stomach Relief", "Other information": "each 15 mL contains : sodium 5 mg each 15 mL contains : salicylate 206 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, glycerin, purified water, sucralose, xanthan gum", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "COMPARE TO PEPTO-BISMOL® ULTRA active ingredient* Ultra Stomach Relief Bismuth Subsalicylate 525 mg per 15 mL Upset Stomach Reliever / Antidiarrheal Relieves Heartburn Indigestion Nausea Upset Stomach Diarrhea 2x Strength per Ounce † †vs. Original Pepto-Bismol® 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 CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com", "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)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:33.763956 · Updated: 2026-03-14T23:03:41.436909