Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID c0a08a05-01e4-43a6-a9e8-70accedde2e6

Route

ORAL

Published

Effective Date 2013-08-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Bismuth Cation (262 mg)

Inactive Ingredients

Calcium Carbonate D&c Red No. 27 Dextrose Magnesium Stearate Maltodextrin Silicon Dioxide Sorbitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2012-09-27

Description

Bismuth subsalicylate 262mg

Purpose

Anti-diarrheal/ Upset stomach reliever

Medication Information

Purpose

Anti-diarrheal/ Upset stomach reliever

Description

Bismuth subsalicylate 262mg

Uses

controls diarrhea
relieves upset stomach due to overindulgence in food or drink

Purposes

Anti-diarrheal/ Upset stomach reliever

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 symtoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Do not take if you are

allergic to salicylates (including aspirin)
taking other salicylate products

Directions

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
repeat dosage every 1/2 to 1 hour as needed
do not take more than 8 doses in 24 hours
use untill diarrhea stops but not more than 2 days
adults and children 12 years and over: 2 tablets
children under 12 years: ask a doctor

Do Not Use

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

Other Information

each tablet contains: calcium 77 mg, salicylate 102 mg
store at 15 to 30⁰C (59 to 86⁰F)
protect from moisture

Inactive Ingredients

calcium carbonate, D&C red #27(Al-lake), dextrose, flavor(cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions Or Comments?

Adverse drug event call 1-(714)-903-7952

Principal Display Panel

NDC 66424-045-30

Stomach Relief

Bismuth Subsalicylate 262 mg

Anti-Diarrheal/ Upset Stomach Reliever

Helps to Relieve:

Upset Stomach
Diarrhea
Indigestion
Heartburn
Nausea

†Compare to the Active Ingredients in Pepto-Bismol

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark 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
ringing in the ears or loss of hearing occurs
diarrhea lasts more than 2 days

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Tablet)

Bismuth subsalicylate 262mg

Ask A Doctor Before Use If You Have

fever
mucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are

talking any drug for

anticoagulation (thinning the blood)
diabetes
gout
arthritis

Structured Label Content

Uses

controls diarrhea
relieves upset stomach due to overindulgence in food or drink

Purposes

Anti-diarrheal/ Upset stomach reliever

Warnings

Allergy alert: Do not take if you are

allergic to salicylates (including aspirin)
taking other salicylate products

Directions

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
repeat dosage every 1/2 to 1 hour as needed
do not take more than 8 doses in 24 hours
use untill diarrhea stops but not more than 2 days
adults and children 12 years and over: 2 tablets
children under 12 years: ask a doctor

Do Not Use (Do not use)

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

Other Information (Other information)

each tablet contains: calcium 77 mg, salicylate 102 mg
store at 15 to 30⁰C (59 to 86⁰F)
protect from moisture

Inactive Ingredients (Inactive ingredients)

calcium carbonate, D&C red #27(Al-lake), dextrose, flavor(cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions Or Comments? (Questions or comments?)

Adverse drug event call 1-(714)-903-7952

Principal Display Panel

NDC 66424-045-30

Stomach Relief

Bismuth Subsalicylate 262 mg

Anti-Diarrheal/ Upset Stomach Reliever

Helps to Relieve:

Upset Stomach
Diarrhea
Indigestion
Heartburn
Nausea

†Compare to the Active Ingredients in Pepto-Bismol

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark 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
ringing in the ears or loss of hearing occurs
diarrhea lasts more than 2 days

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.

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

ask a health professional before use.

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Bismuth subsalicylate 262mg

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)

talking any drug for

anticoagulation (thinning the blood)
diabetes
gout
arthritis

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "controls diarrhea relieves upset stomach due to overindulgence in food or drink", "Purposes": "Anti-diarrheal/ Upset stomach reliever", "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 symtoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products", "Directions": "drink plenty of clear fluids to help prevent dehydration caused by diarrhea repeat dosage every 1/2 to 1 hour as needed do not take more than 8 doses in 24 hours use untill diarrhea stops but not more than 2 days adults and children 12 years and over: 2 tablets children under 12 years: ask a doctor", "Do not use": "if you have bloody or black stool if you have an ulcer or bleeding problem", "Other information": "each tablet contains: calcium 77 mg, salicylate 102 mg store at 15 to 30 0 C (59 to 86 0 F) protect from moisture", "Inactive ingredients": "calcium carbonate, D&C red #27(Al-lake), dextrose, flavor(cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol", "Questions or comments?": "Adverse drug event call 1-(714)-903-7952", "Principal Display Panel": "NDC 66424-045-30 Stomach Relief Bismuth Subsalicylate 262 mg Anti-Diarrheal/ Upset Stomach Reliever Helps to Relieve: Upset Stomach Diarrhea Indigestion Heartburn Nausea †Compare to the Active Ingredients in Pepto-Bismol TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING †This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark 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 ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days", "Keep out of reach of children": "In case of overdose, get medical help or contact a Poison Control Center right away.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Active Ingredient (in each tablet)": "Bismuth subsalicylate 262mg", "Ask a doctor before use if you have": "fever mucus in the stool", "Ask a doctor or pharmacist before use if you are": "talking any drug for anticoagulation (thinning the blood) diabetes gout arthritis"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:40.969991 · Updated: 2026-03-14T22:53:34.467425