Package Label

Package Label
SPL v5
SPL
SPL Set ID 081a1c39-3b88-4f1e-8260-2afdf5d70782
Route
ORAL
Published
Effective Date 2026-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Bismuth subsalicylate 525 mg


Medication Information

Warnings and Precautions

  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

Indications and Usage

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

Dosage and Administration

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: 30 mL (1 dose) 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 of age: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Description

Bismuth subsalicylate 525 mg

Section 44425-7

each 30 mL contains : sodium 6 mg each 30 mL contains : salicylate 243 mg low sodium keep tightly closed protect from freezing avoid excessive heat (over 104ºF or 40ºC)

Section 50565-1

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

Section 50566-9

symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days

Section 50567-7

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

Section 50568-5

taking any drug for diabetes gout arthritis anticoagulation (thinning the blood)

Section 50569-3

fever mucus in the stool

Section 50570-1

if you have an ulcer a bleeding problem bloody or black stool

Section 51727-6

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

Section 51945-4

Compare to the active ingredient in Pepto-Bismol®* REGULAR STRENGTH STOMACH RELIEF BISMUTH SUBSALICYLATE  525mg UPSET STOMACH RELIEVER ANTIDIARRHEAL relieves: heartburn • indigestion • nausea upset stomach • diarrhea 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 Protecter & Gamble Company. TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: RITE AID 30 HUNTER LANE, CAMP HILL, PA 17011

Section 53413-1

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

Section 53414-9

ask a health professional before use.

Section 55105-1

Upset stomach reliever/Antidiarrheal

Section 55106-9

Bismuth subsalicylate 525 mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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: 30 mL (1 dose) 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 of age: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Warnings and Precautions (34071-1)

  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

Section 44425-7 (44425-7)

each 30 mL contains : sodium 6 mg each 30 mL contains : salicylate 243 mg low sodium keep tightly closed protect from freezing avoid excessive heat (over 104ºF or 40ºC)

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

taking any drug for diabetes gout arthritis anticoagulation (thinning the blood)

Section 50569-3 (50569-3)

fever mucus in the stool

Section 50570-1 (50570-1)

if you have an ulcer a bleeding problem bloody or black stool

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Compare to the active ingredient in Pepto-Bismol®* REGULAR STRENGTH STOMACH RELIEF BISMUTH SUBSALICYLATE  525mg UPSET STOMACH RELIEVER ANTIDIARRHEAL relieves: heartburn • indigestion • nausea upset stomach • diarrhea 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 Protecter & Gamble Company. TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: RITE AID 30 HUNTER LANE, CAMP HILL, PA 17011

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Upset stomach reliever/Antidiarrheal

Section 55106-9 (55106-9)

Bismuth subsalicylate 525 mg


Raw Label Data

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