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
- 5
- Source
- daily-update
- Hydrated at
- 2026-10-09 01:01:15
Label at a glance#
ProductPepto Bismol CHEWABLES
Active ingredientBISMUTH SUBSALICYLATE
Label structure20 sections
Dosage and administration
• chew or dissolve in mouth • adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • 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 • d...
Storage and handling
each tablet contains : calcium 140 mg, magnesium 9 mg salicylate 101 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 tablet)
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
Do not use if
you have
- an ulcer
- a bleeding problem
- bloody or black stool
Ask a doctor before use if you have
- fever
- mucus in the stool
Ask a doctor or pharmacist before use if you are
taking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
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
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.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• chew or dissolve in mouth
• adults and children 12 years and over:
- 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
- 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
• 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
- each tablet contains: calcium 140 mg, magnesium 9 mg
- salicylate 101 mg
- low sodium
- avoid excessive heat (over 104°F or 40°C)
Inactive ingredients
calcium carbonate, D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc
Questions?
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 Tablet Carton
Pepto
Bismol®
Bismuth Subsalicylate
Upset Stomach Reliever/ Antidiarrheal
CHEWABLES
5 SYMPTOM
RELIEF
NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA
12 CHEWABLE TABLETS
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
Products#
Every source-derived product name is available through these pages.
- Pepto Bismol CHEWABLES
- Bismuth Subsalicylate
- SALICYLIC ACID
- CALCIUM CARBONATE
- MAGNESIUM STEARATE
- MANNITOL
- POVIDONE
- D&C RED NO. 27 ALUMINUM LAKE
- SACCHARIN SODIUM
- TALC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58933-011 | 58933-011-02, 58933-011-12, 58933-011-30, 58933-011-48, 58933-011-04, 58933-011-90 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| D&C RED NO. 27 ALUMINUM LAKE | ZK64F7XSTX | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| TALC | 7SEV7J4R1U | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2025-10-01 | full-release | 2026-06-01 01:15:24 |
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 |
|---|---|---|---|---|---|---|
| 401d00ba-8c3f-04fa-e063-6294a90abe9e | 06fce961-5e57-b640-e063-6394a90a9e8a | 2025-10-01 | Warnings | 06fce961-5e57-b640-e063-6394a90a9e8a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.