Pepto Bismol ®

Pepto Bismol ®
SPL v7
SPL
SPL Set ID 84ef6f9a-ba4e-66b1-e053-2991aa0a0c34
Route
ORAL
Published
Effective Date 2023-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (525 mg)
Inactive Ingredients
Calcium Carbonate Magnesium Stearate Mannitol Cellulose, Microcrystalline Polysorbate 80 Povidone D&c Red No. 27 Aluminum Lake Sodium Starch Glycolate Type A Potato Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: Pepto Shape: oval Color: pink Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-03-01 Until 2026-06-30
Description

Drug Facts

Purpose

Antidiarrheal

Medication Information

Purpose

Antidiarrheal

Description

Drug Facts

Uses

relieves

  • travelers' diarrhea
  • diarrhea
Section 34088-5

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Directions
  • swallow with water, do not chew
  • adults and children 12 years and over: 
  • 1 caplet every ½ hour or 2 caplets every hour as needed
  • do not exceed 8 caplets 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
Questions?

1-800-717-3786

Allergy Alert:

Contains salicylate .

Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
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.

Other Information
  • each caplet contains: calcium 54 mg
  • salicylate 199 mg
  • very low sodium
  • avoid excessive heat (over 104°F or 40°C)
Inactive Ingredients

calcium carbonate, D&C Red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate

Do Not Use If You Have
  • an ulcer
  • a bleeding problem
  • bloody or black stool
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
If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Caplet)

Bismuth subsalicylate 525 mg

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
Principal Display Panel 12 Caplet Carton

Pepto ®

Diarrhea

Bismuth Subsalicylate

Antidiarrheal

2x CONCENTRATED FORMULA*

COATS & KILLS BACTERIA THAT CAUSE DIARRHEA

12 CAPLETS

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
Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Antidiarrheal

Directions
  • swallow with water, do not chew
  • adults and children 12 years and over: 
  • 1 caplet every ½ hour or 2 caplets every hour as needed
  • do not exceed 8 caplets 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
Questions?

1-800-717-3786

Allergy Alert: (Allergy alert:)

Contains salicylate .

Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
Reye's Syndrome: (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.

Other Information (Other information)
  • each caplet contains: calcium 54 mg
  • salicylate 199 mg
  • very low sodium
  • avoid excessive heat (over 104°F or 40°C)
Inactive Ingredients (Inactive ingredients)

calcium carbonate, D&C Red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate

Do Not Use If You Have (Do not use if you have)
  • an ulcer
  • a bleeding problem
  • bloody or black stool
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
If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

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
Principal Display Panel 12 Caplet Carton (PRINCIPAL DISPLAY PANEL - 12 Caplet Carton)

Pepto ®

Diarrhea

Bismuth Subsalicylate

Antidiarrheal

2x CONCENTRATED FORMULA*

COATS & KILLS BACTERIA THAT CAUSE DIARRHEA

12 CAPLETS

Ask A Doctor Or Pharmacist Before Use If You Are (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: 2026-02-15T12:03:44.985600 · Updated: 2026-03-14T23:03:58.855522