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
- JC World Bell Wholesale Co., Inc.
- Effective date
- 2021-10-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:31:57
Label at a glance#
ProductPepto Bismol
Active ingredientBISMUTH SUBSALICYLATE
Label structure8 sections
Dosage and administration
• swallow with water, do not chew • adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed • 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
Contacts and useful links#
Label contents#
Full prescribing information#
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
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 • 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.
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 every 1/2 to 1 hour as needed
• 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 [• very low sodium] • avoid excessive heat (over 104ºF or 40ºC)
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
Package Labeling:
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 37000-476-02 | EA - Each | 37000-476 | 29cf9157-f172-435e-a630-d8b504d31355 | 1 | 2015-10-02 |
| 37000-476-03 | EA - Each | 37000-476 | f48857f1-cfc1-43b9-b962-87c1e563058f | 1 | 2015-10-02 |
Products#
Every source-derived product name is available through these pages.
- Pepto Bismol
- BISMUTH SUBSALICYLATE
- CALCIUM CARBONATE
- MAGNESIUM STEARATE
- MANNITOL
- CELLULOSE, MICROCRYSTALLINE
- POLYSORBATE 80
- POVIDONE, UNSPECIFIED
- SILICON DIOXIDE
- SALICYLIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50269-476 | 50269-476-01 |
| 37000-476 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
Source Document#
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 |
|---|---|---|---|---|---|---|
| ceb8a879-9ff2-1d99-e053-2a95a90a9bb0 | aa7039b0-5e5c-439c-99aa-a7ac217ffeaf | 2021-10-19 | Warnings | ceb8a879-9ff2-1d99-e053-2a95a90a9bb0 aa7039b0-5e5c-439c-99aa-a7ac217ffeaf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.