FDA.reportPublic FDA data

Pepto Bismol

Manufacturer
Procter & Gamble Manufactura S de RL de CV
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-09 01:01:22

Label at a glance#

ProductPepto Bismol CHEWABLES
Active ingredientBISMUTH SUBSALICYLATE
Label structure19 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

• fully chew or dissolve in mouth before swallowing • adults and children 12 years and over:      • 2 chewable tablets (1 dose) every 1/2 hour to 1 hour or 4 chewable tablets (2 doses) every hour as needed for diarrhea      • 2 chewable tablets (1 dose) every 1/2 hour to 1 our as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 chewable tablets) in 24 hours • us...

Storage and handling

each chewable tablet contains: calcium 140 mg, magnesium 10 mg salicylate 101 mg low sodium Store at no greater than 77°F. Avoid excessive heat (over 104°F.)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

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.

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• fully chew or dissolve in mouth before swallowing
• adults and children 12 years and over:

     • 2 chewable tablets (1 dose) every 1/2 hour to 1 hour or 4 chewable tablets (2 doses) every hour as needed for diarrhea

     • 2 chewable tablets (1 dose) every 1/2 hour to 1 our as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

• do not exceed 8 doses (16 chewable 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

STORAGE AND HANDLING SECTION

  • each chewable tablet contains:
  • calcium 140 mg, magnesium 10 mg
  • salicylate 101 mg
  • low sodium
  • Store at no greater than 77°F. Avoid excessive heat (over 104°F.)

Inactive ingredients

INACTIVE INGREDIENT SECTION

adipic acid, calcium carbonate, D&C Red No 27 Aluminum Lake, FD&C Red No 40 Aluminum Lake, Flavors, magnesium stearate, mannitol, povidone, saccharin sodium, talc, water

Questions?

OTC - QUESTIONS SECTION

1-800-717-3786

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF THE PRINTED INNER WRAP IS BROKEN OR MISSING.

SPL UNCLASSIFIED SECTION

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 12 Chewable Tablets Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pepto
Bismol ®

CHEWABLES


Bismuth Subsalicylate
Upset Stomach Reliever/ Antidiarrheal


TRAVEL SIZE


FAST 5 SYMPTOM RELIEF


NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

12 CHEWABLE TABLETS

002002

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix21284407002.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58933-00258933-002-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TALC7SEV7J4R1UIACT
CALCIUM CARBONATEH0G9379FGKIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
POVIDONEFZ989GH94EIACT
ADIPIC ACID76A0JE0FKJIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-03-19full-release2026-06-01 00:58:13

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 CHEWABLESBISMUTH SUBSALICYLATEProcter & Gamble Manufactura S de RL de CV30b6adb2-48da-875b-e063-6394a90a593b2025-03-19WarningsExact identifier
ndc (package): 58933-002-12
ndc (product): 58933-002
ndc11 (package): 58933000212
spl set id: 30b6adb2-48da-875b-e063-6394a90a593b

Reported adverse events (FAERS/openFDA)#

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