FDA.reportPublic FDA data

Pepto Bismol

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
daily-update
Hydrated at
2026-10-09 01:01:53

Label at a glance#

ProductPepto Bismol Liquicaps
Active ingredientBISMUTH SUBSALICYLATE
Label structure21 sections

Indications and uses

relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness

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 hour as needed for diarrhea • 2 LiquiCaps every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • 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 c...

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

Upset stomach reliever and antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness

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

OTC - DO NOT USE SECTION

you have

  • 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 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE 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 hour as needed for diarrhea
• 2 LiquiCaps every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
• 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

TAMPER EVIDENT: THIS PACKAGE IS SAFETY SEALED & CHILD RESISTANT. USE ONLY IF BLISTERS ARE INTACT. IF DIFFICULT TO OPEN, USE SCISSORS.

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
Bismol®

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

LIQUICAPS

5 SYMPTOM RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

48 LIQUICAPS™

535535

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130301490001769GTIN-13: 0301490001769
EAN-13: 0301490001769
GTIN-12: 301490001769
UPC-A: 301490001769
GTIN storage (14 digits): 00301490001769		535.jpg
QR code linkQR Codescan.pg.com/01/00301490001769535.jpg
Data codeData Matrix21322217535.jpg

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
37000-535-122021-02-12C16284748780-1ba0f9c33-3a0b-a910-e053-dadaa90a0b85Pepto Bismol ® LiquiCaps
37000-535-122021-02-12C16284748780-1ba0f9c33-3a0b-a910-e053-dadaa90a0b85Pepto Bismol ® LiquiCaps
37000-535-242021-02-12C16284748780-1ba0f9c33-3a0b-a910-e053-dadaa90a0b85Pepto Bismol ® LiquiCaps
37000-535-242021-02-12C16284748780-1ba0f9c33-3a0b-a910-e053-dadaa90a0b85Pepto Bismol ® LiquiCaps
37000-535-482021-02-12C16284748780-1ba0f9c33-3a0b-a910-e053-dadaa90a0b85Pepto Bismol ® LiquiCaps
37000-535-482021-02-12C16284748780-1ba0f9c33-3a0b-a910-e053-dadaa90a0b85Pepto Bismol ® LiquiCaps
37000-535-122021-01-29C16284748780-1ba0f9c33-3a0b-a910-e053-dadaa90a0b85Pepto Bismol ® LiquiCaps
37000-535-122021-01-29C16284748780-1ba0f9c33-3a0b-a910-e053-dadaa90a0b85Pepto Bismol ® LiquiCaps
37000-535-242021-01-29C16284748780-1ba0f9c33-3a0b-a910-e053-dadaa90a0b85Pepto Bismol ® LiquiCaps
37000-535-242021-01-29C16284748780-1ba0f9c33-3a0b-a910-e053-dadaa90a0b85Pepto Bismol ® LiquiCaps
37000-535-482021-01-29C16284748780-1ba0f9c33-3a0b-a910-e053-dadaa90a0b85Pepto Bismol ® LiquiCaps
37000-535-482021-01-29C16284748780-1ba0f9c33-3a0b-a910-e053-dadaa90a0b85Pepto Bismol ® LiquiCaps

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
37000-53537000-535-12, 37000-535-24, 37000-535-48

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
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
POLYSORBATE 207T1F30V5YHIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
GELATIN2G86QN327LIACT
POVIDONEFZ989GH94EIACT
D&C RED NO. 339DBA0SBB0LIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122026-04-23full-release2026-06-01 01:54:54

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
Pepto Bismol LiquicapsBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Company84ffa6d6-03e1-59e8-e053-2a91aa0afd6e2026-04-23WarningsExact identifier
ndc (package): 37000-535-24
ndc (package): 37000-535-12
ndc (package): 37000-535-48
ndc (product): 37000-535
ndc11 (package): 37000053548
ndc11 (package): 37000053512
ndc11 (package): 37000053524
spl set id: 84ffa6d6-03e1-59e8-e053-2a91aa0afd6e

Reported adverse events (FAERS/openFDA)#

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