Indications and uses
relieves traveler's diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness
Pepto Bismol
- Manufacturer
- The Procter & Gamble Manufacturing Company
- Effective date
- 2026-10-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 19
- Source
- daily-update
- Hydrated at
- 2026-10-09 01:01:42
Label at a glance#
ProductPepto-Bismol
Active ingredientBISMUTH SUBSALICYLATE
Label structure11 sections
Dosage and administration
shake well before use only use dose cup provided adults and children 12 years and over: 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea 30mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (240 mL) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a ...
Storage and handling
each 30 mL dose contains: magnesium 3 mg, sodium 4 mg salicylate 261 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.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each 30 mL dose)
Bismuth subsalicylate 525 mg
Purpose
Upset stomach reliever and antidiarrheal
Uses
relieves
- traveler's diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness
Warnings
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
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
- 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
- shake well before use
- only use dose cup provided
- adults and children 12 years and over:
- 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
- 30mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (240 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
- each 30 mL dose contains: magnesium 3 mg, sodium 4 mg
- salicylate 261 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
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?
1-800-717-3786
SPL UNCLASSIFIED SECTION
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
Pepto
Bismol®
Bismuth Subsalicylate
Upset Stomach Reliever
Antidiarrheal
COATS & SOOTHES
5 SYMPTOM
RELIEF
NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA
16 FL OZ (473 mL)
Product Linked Resources#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15 | Product name | 1 | 20240313 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
FDA-Initiated Inactive NDC Indexing#
Products#
Every source-derived product name is available through these pages.
- Pepto-Bismol
- Bismuth subsalicylate
- SALICYLIC ACID
- BISMUTH CATION
- GELLAN GUM (HIGH ACYL)
- MAGNESIUM ALUMINUM SILICATE
- BENZOIC ACID
- D&C RED NO. 22
- D&C RED NO. 28
- SUCRALOSE
- SODIUM SALICYLATE
- SORBIC ACID
- WATER
- METHYLCELLULOSE, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37000-438 | 37000-438-04, 37000-438-08, 37000-438-12, 37000-438-16, 37000-438-24, 37000-438-32, 37000-438-34 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| GELLAN GUM (HIGH ACYL) | W1L7G7ROMD | IACT |
| MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | IACT |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| D&C RED NO. 22 | 1678RKX8RT | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SALICYLIC ACID | O414PZ4LPZ | IACT |
| SODIUM SALICYLATE | WIQ1H85SYP | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| WATER | 059QF0KO0R | IACT |
| METHYLCELLULOSE, UNSPECIFIED | Z944H5SN0H | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 18 | 2026-03-24 | full-release | 2026-06-01 01:51:24 |
| 16 | 2025-10-06 | monthly-update | 2026-06-03 17:38:12 |
| 15 | 2025-10-01 | full-release | 2026-06-01 01:15:27 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pepto-Bismol | BISMUTH SUBSALICYLATE | The Procter & Gamble Manufacturing Company | 67006e82-870d-8d63-e053-2991aa0a02d1 | 2026-03-24 | Warnings | 37000-438-16 37000-438-34 37000-438-32 37000-438-24 37000-438-04 37000-438-12 37000-438-08 37000-438 37000043804 37000043834 37000043808 37000043824 37000043832 37000043812 37000043816 67006e82-870d-8d63-e053-2991aa0a02d1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.