FDA.reportPublic FDA data

Pepto Bismol

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-10-09 01:01:49

Label at a glance#

ProductPepto Bismol Ultra
Active ingredientBISMUTH SUBSALICYLATE
Label structure11 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

shake well before use only use dose cup provided adults and children 12 years and over: 15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea 15 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (120 mL) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a...

Storage and handling

each 15 mL dose cup contains:  magnesium 3 mg, sodium 2 mg salicylate 230 mg low sodium protect from freezing avoid excessive heat (over 104°F or 40°C) TAMPER EVIDENT:  Do not use if printed shrinkband is missing or broken.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 15 mL dose)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 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: Contains salicylate. Do not take if you are

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

Do not use if you have

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • fever
  • mucus in the stool

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any drug for

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

OTC - WHEN USING SECTION

When using this product 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • only use dose cup provided
  • adults and children 12 years and over:
  • 15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
  • 15 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (120 mL) 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 15 mL dose cup contains: magnesium 3 mg, sodium 2 mg
    • salicylate 230 mg
    • low sodium
    • protect from freezing
    • avoid excessive heat (over 104°F or 40°C)
  • TAMPER EVIDENT: Do not use if printed shrinkband is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, magnesium aluminum silicate, methylcellulose, salicylic acid, sodium salicylate, sorbic acid, sucralose, water

Questions?

OTC - QUESTIONS SECTION

1-800-717-3786

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pepto

Bismol®ULTRA

Bismuth Subsalicylate
Upset Stomach Reliever/ Antidiarrheal

2x CONCENTRATED FORMULA*


5 SYMPTOM

RELIEF

NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

WINTER FROST

12 FL OZ (354 mL)

966966

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130301490002124GTIN-13: 0301490002124
EAN-13: 0301490002124
GTIN-12: 301490002124
UPC-A: 301490002124
GTIN storage (14 digits): 00301490002124		966.jpg
Data codeData Matrix21416881966.jpg
Data codeData Matrix21432538966.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

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
69423-96669423-966-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
D&C RED NO. 221678RKX8RTIACT
D&C RED NO. 28767IP0Y5NHIACT
SUCRALOSE96K6UQ3ZD4IACT
SALICYLIC ACIDO414PZ4LPZIACT
SODIUM SALICYLATEWIQ1H85SYPIACT
SORBIC ACIDX045WJ989BIACT
WATER059QF0KO0RIACT
METHYLCELLULOSE (1500 MPA.S)P0NTE48364IACT
GELLAN GUM (HIGH ACYL)W1L7G7ROMDIACT
METHYLCELLULOSE, UNSPECIFIEDZ944H5SN0HIACT
BENZOIC ACID8SKN0B0MIMIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92026-09-09daily-update2026-09-11 03:01:16
82026-01-09monthly-update2026-06-03 17:52:37
72025-07-23full-release2026-06-01 01:08:29

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 UltraBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Companyd800eb8c-42c8-fb12-e053-2a95a90af2a22026-09-09WarningsExact identifier
ndc (package): 69423-966-12
ndc (product): 69423-966
ndc11 (package): 69423096612
spl set id: d800eb8c-42c8-fb12-e053-2a95a90af2a2

Reported adverse events (FAERS/openFDA)#

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