FDA.reportPublic FDA data

Pepto Bismol

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:02:50

Label at a glance#

ProductPepto Bismol Diarrhea Liquicaps
Active ingredientBISMUTH SUBSALICYLATE
Label structure11 sections

Indications and uses

relieves travelers' diarrhea diarrhea

Dosage and administration

• swallow with water, do not chew • adults and children 12 years and over: • 2 LiquiCaps every ½ hour or 4 LiquiCaps every 1 hour as needed • do not exceed 16 LiquiCaps 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 LiquiCap contains: salicylate 199 mg low sodium do not exceed 25°C

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each LiquiCap)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 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

OTC - ASK DOCTOR/PHARMACIST SECTION

 if you are 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 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,

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:
• 2 LiquiCaps every ½ hour or 4 LiquiCaps every 1 hour as needed
• do not exceed 16 LiquiCaps 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 LiquiCap contains:
  • salicylate 199 mg
  • low sodium
  • do not exceed 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red No. 33, gelatin, glycerin, polyethylene glycol, polysorbate 20, povidone, sorbitol sorbitan solution, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-717-3786

SPL UNCLASSIFIED SECTION

MADE IN CANADA

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 48 LiquiCap Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAST & SOOTHING RELIEF

Pepto®

Diarrhea

Bismuth Subsalicylate

Antidiarrheal

LIQUICAPS

COATS & KILLS BACTERIA THAT CAUSE DIARRHEA

48 LIQUICAPS™

537537

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2121072bismuth subsalicylate 262 MG Oral CapsulePSN10
2121074Pepto-Bismol 262 MG Oral CapsulePSN10
2121074bismuth subsalicylate 262 MG Oral Capsule [Pepto-bismol]SBD10
2121072bismuth subsalicylate 262 MG Oral CapsuleSCD10
2121074Pepto-bismol 262 MG Oral CapsuleSY10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-537-122021-02-12C16284748780-1ba0f9c33-1bb6-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea LiquiCaps
37000-537-242021-02-12C16284748780-1ba0f9c33-1bb6-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea LiquiCaps
37000-537-482021-02-12C16284748780-1ba0f9c33-1bb6-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea LiquiCaps
37000-537-122021-01-29C16284748780-1ba0f9c33-1bb6-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea LiquiCaps
37000-537-242021-01-29C16284748780-1ba0f9c33-1bb6-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea LiquiCaps
37000-537-482021-01-29C16284748780-1ba0f9c33-1bb6-a910-e053-dadaa90a0b85Pepto Bismol ® Diarrhea LiquiCaps

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-537-12Pepto BismolDiarrhea Liquicaps1 in 1 CARTONCAPSULE, LIQUID FILLED110
37000-537-12Pepto BismolDiarrhea Liquicaps12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
37000-537-24Pepto BismolDiarrhea Liquicaps12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
37000-537-24Pepto BismolDiarrhea Liquicaps2 in 1 CARTONCAPSULE, LIQUID FILLED210
37000-537-48Pepto BismolDiarrhea Liquicaps12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
37000-537-48Pepto BismolDiarrhea Liquicaps4 in 1 CARTONCAPSULE, LIQUID FILLED410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-537PEPTO BISMOL DIARRHEA LIQUICAPS (BISMUTH SUBSALICYLATE) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Legacy NDC, 6 package rows20231129_851997d7-cb82-17bf-e053-2a91aa0ab78b.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-53737000-537-12, 37000-537-24, 37000-537-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 207T1F30V5YHIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
GELATIN2G86QN327LIACT
POVIDONEFZ989GH94EIACT
D&C RED NO. 339DBA0SBB0LIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB

Source Document#

Source XML · Source PDF

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
0b3cb53e-1d79-f343-e063-6394a90a17ca851997d7-cb82-17bf-e053-2a91aa0ab78b2023-11-28WarningsExact identifier
spl id: 0b3cb53e-1d79-f343-e063-6394a90a17ca
spl set id: 851997d7-cb82-17bf-e053-2a91aa0ab78b

Reported adverse events (FAERS/openFDA)#

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