Indications and uses
relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness
Pepto BISMOL
- Manufacturer
- Procter & Gamble Manufactura S de RL de CV
- Effective date
- 2026-10-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- daily-update
- Hydrated at
- 2026-10-09 01:01:02
Label at a glance#
ProductPepto-Bismol
Active ingredientBISMUTH SUBSALICYLATE
Label structure12 sections
Dosage and administration
• swallow with water, do not chew • adults and children 12 years and over: 2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea 2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 caplets) in 24 hours • use until diarrhea stops but not more than 2 days • children under 12 years: ask a doctor • d...
Storage and handling
each caplet contains: calcium 27 mg salicylate 99 mg low sodium avoid excessive heat (over 104°F or 40°C)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each caplet)
Bismuth subsalicylate 262 mg
Purpose
Upset stomach reliever and antidiarrheal
Uses
relieves
- travelers' 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
OTC - STOP USE SECTION
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
• swallow with water, do not chew
• adults and children 12 years and over:
- 2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea
- 2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
• do not exceed 8 doses (16 caplets) 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 caplet contains: calcium 27 mg
- salicylate 99 mg
- low sodium
- avoid excessive heat (over 104°F or 40°C)
Inactive ingredients
calcium carbonate, D&C red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate
Questions?
1-800-717-3786
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: Do not use if inner printed seal on bottle is broken or missing.
SPL UNCLASSIFIED SECTION
Made in Mexico
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202
PRINCIPAL DISPLAY PANEL - 24 Caplet Carton
Pepto
Bismol
®
Bismuth Subsalicylate
Upset Stomach Reliever/
Antidiarrheal
5 SYMPTOM RELIEF
NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA
24 CAPLETS
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0301490039908 | GTIN-13: 0301490039908 EAN-13: 0301490039908 GTIN-12: 301490039908 UPC-A: 301490039908 GTIN storage (14 digits): 00301490039908 | 476.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
FDA-Initiated Inactive NDC Indexing#
Products#
Every source-derived product name is available through these pages.
- Pepto-Bismol
- Bismuth subsalicylate
- SALICYLIC ACID
- D&C RED NO. 27 ALUMINUM LAKE
- CALCIUM CARBONATE
- MAGNESIUM STEARATE
- MANNITOL
- CELLULOSE, MICROCRYSTALLINE
- POLYSORBATE 80
- SILICON DIOXIDE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58933-476 | 58933-476-01, 58933-476-02, 58933-476-03, 58933-476-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| D&C RED NO. 27 ALUMINUM LAKE | ZK64F7XSTX | IACT |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 9 | 2025-10-09 | full-release | 2026-06-01 01:38:32 |
| 8 | 2024-10-10 | full-release | 2026-06-01 00:24:15 |
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 | Procter & Gamble Manufactura S de RL de CV | 66d9d631-ba73-3ce4-e053-2a91aa0a1cc4 | 2025-10-09 | Warnings | 58933-476-12 58933-476-01 58933-476-02 58933-476-03 58933-476 58933047601 58933047602 58933047603 58933047612 66d9d631-ba73-3ce4-e053-2a91aa0a1cc4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.