FDA.reportPublic FDA data

Pepto Bismol

Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2026-04-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:52:54

Label at a glance#

ProductPepto Bismol
Active ingredientBISMUTH SUBSALICYLATE
Label structure8 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

• 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

Label contents#

Full prescribing information#

Active ingredient (in each Chewable tablet)

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: 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

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 taking any drug for

OTC - ASK DOCTOR/PHARMACIST SECTION

• 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

• 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

Other information

SPL UNCLASSIFIED SECTION

• 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-717-3786

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PeptoPepto

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN4
211151Pepto-Bismol 262 MG Chewable TabletPSN4
211151bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]SBD4
308761bismuth subsalicylate 262 MG Chewable TabletSCD4
211151Pepto-bismol 262 MG Chewable TabletSY4
211151Pepto-Bismol InstaCool 262 MG Chewable TabletSY4
211151Pepto-Bismol To-Go 262 MG Chewable TabletSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-155-012024-04-15C16284748780-1f386c649-f669-0266-e053-dadaa90a7c1aPepto Bismol
67751-155-022024-04-15C16284748780-1f386c649-f669-0266-e053-dadaa90a7c1aPepto Bismol
67751-155-012023-01-30C16284748780-1f386c649-f669-0266-e053-dadaa90a7c1aPepto Bismol
67751-155-022023-01-30C16284748780-1f386c649-f669-0266-e053-dadaa90a7c1aPepto Bismol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-155-01Pepto Bismol1 in 1 CARTONTABLET, CHEWABLE14
67751-155-01Pepto Bismol2 in 1 POUCHTABLET, CHEWABLE24
67751-155-02Pepto Bismol1 in 1 CARTONTABLET, CHEWABLE14
67751-155-02Pepto Bismol4 in 1 POUCHTABLET, CHEWABLE44
67751-155-06Pepto Bismol2 in 1 POUCHTABLET, CHEWABLE24
67751-155-06Pepto Bismol3 in 1 CARTONTABLET, CHEWABLE34

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
67751-15567751-155-01, 67751-155-02, 67751-155-06
58933-011

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
D&C RED NO. 272LRS185U6KIACT
ALUMINUM OXIDELMI26O6933IACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
POVIDONEFZ989GH94EIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TALC7SEV7J4R1UIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CALCIUM CARBONATEH0G9379FGKIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pepto BismolBISMUTH SUBSALICYLATENavajo Manufacturing Company Inc.033bccc6-6e81-487f-91fe-9d7cc465e1b22026-04-08WarningsExact identifier
ndc (package): 67751-155-01
ndc (package): 67751-155-02
ndc (package): 67751-155-06
ndc (product): 67751-155
ndc11 (package): 67751015506
ndc11 (package): 67751015502
ndc11 (package): 67751015501
spl id: 4efb4585-b90f-f303-e063-6294a90a4ba6
spl set id: 033bccc6-6e81-487f-91fe-9d7cc465e1b2
Pepto Bismol CHEWABLESBISMUTH SUBSALICYLATEProcter & Gamble Manufactura S de RL de CV06fce961-5e57-b640-e063-6394a90a9e8a2025-10-01WarningsExact identifier
ndc (product): 58933-011

Reported adverse events (FAERS/openFDA)#

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