FDA.reportPublic FDA data

Pepto-Bismol

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-10-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:24:54

Label at a glance#

ProductPepto-Bismol Diarrhea
Active ingredientBISMUTH SUBSALICYLATE
Label structure12 sections

Indications and uses

relieves travelers' diarrhea diarrhea

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg

Purpose

OTC - PURPOSE SECTION

Antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

  • travelers' diarrhea
  • diarrhea

Warnings

WARNINGS SECTION

Reye's syndrome:

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

Contains salicylate .

Do not take if you are

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

Do not use if you have

OTC - DO NOT USE SECTION

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-717-3786

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: Do not use if inner printed seal on bottle is broken or missing.

SPL UNCLASSIFIED SECTION

MADE IN MEXICO
DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 12 Caplet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pepto®
Diarrhea

Bismuth Subsalicylate

Antidiarrheal

2x CONCENTRATED FORMULA*

COATS & KILLS BACTERIA THAT CAUSE DIARRHEA

12 CAPLET391391S

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-391-122021-02-12C16284748780-1ba0f9c33-1b50-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea Caplets
37000-391-122021-01-29C16284748780-1ba0f9c33-1b50-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea Caplets

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-39137000-391-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONEFZ989GH94EIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0ac22f64-ff8f-4608-e063-6294a90a113784ef11ab-2707-4d42-e053-2991aa0a96bd2023-11-22WarningsExact identifier
spl set id: 84ef11ab-2707-4d42-e053-2991aa0a96bd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.