Pepto Bismol

Pepto Bismol
SPL v3
SPL
SPL Set ID 033bccc6-6e81-487f-91fe-9d7cc465e1b2
Route
ORAL
Published
Effective Date 2016-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Calcium Carbonate D&c Red No. 27 Aluminum Oxide Magnesium Stearate Mannitol Povidone Saccharin Sodium Talc

Identifiers & Packaging

Pill Appearance
Imprint: Pepto;Bismol Shape: round Color: pink Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-09-20
Description

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal

Medication Information

Purpose

Upset stomach reliever and antidiarrheal

Description

Bismuth subsalicylate 262 mg

Uses

Relieves

• travelers' diarrhea

• diarrhea

• upset stomach due to overindulgence in food and drink, including:

• heartburn • indigestion • nausea 

• gas • belching • fullness

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

• chew or dissolve in mouth

• adults and children 12 years and over:

• 2 tablets every 1/2 to 1 hour as needed

• do not exceed 8 doses (16 tablets) 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

Drug Facts

Questions?

1-800-717-3786

Other Information

• each tablet contains:

• calcium 140 mg

• magnesium 9 mg

• salicylate 101 mg

• very low sodium

• protect from freezing

• avoid excessive heat (over 104°F or 40°C)

• do not use if pouch is opened

Package Labeling:

Inactive Ingredients

calcium carbonate, D&C red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

When Using This Product

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

Do Not Use If You Have 

• an ulcer

• a bleeding problem

• bloody or black stool

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

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.

Ask A Doctor Before Use If you Have

• fever

• mucus in the stool

Active Ingredient (in Each Chewable tablet)

Bismuth subsalicylate 262 mg

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 • nausea 

• gas • belching • fullness

Purpose

Upset stomach reliever and 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

• chew or dissolve in mouth

• adults and children 12 years and over:

• 2 tablets every 1/2 to 1 hour as needed

• do not exceed 8 doses (16 tablets) 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

Drug Facts

Questions?

1-800-717-3786

Other Information (Other information)

• each tablet contains:

• calcium 140 mg

• magnesium 9 mg

• salicylate 101 mg

• very low sodium

• protect from freezing

• avoid excessive heat (over 104°F or 40°C)

• do not use if pouch is opened

Package Labeling:

Inactive Ingredients (Inactive ingredients)

calcium carbonate, D&C red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

When Using This Product (When using this product)

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

Do Not Use If You Have  (Do not use if you have )

• an ulcer

• a bleeding problem

• bloody or black stool

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

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.

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

• fever

• mucus in the stool

Active Ingredient (in Each Chewable tablet) (Active ingredient (in each Chewable tablet))

Bismuth subsalicylate 262 mg

Ask A Doctor Or Pharmacist Before Use If You Are taking Any Drug For (Ask a doctor or pharmacist before use if you are taking any drug for)

• anticoagulation (thinning the blood)

• diabetes

• gout

• arthritis

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:58.135571 · Updated: 2026-03-14T23:02:48.423363