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
- The Procter & Gamble Manufacturing Company
- Effective date
- 2023-10-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:24:53
Label at a glance#
ProductPepto-Bismol ULTRA
Active ingredientBISMUTH SUBSALICYLATE
Label structure21 sections
Dosage and administration
swallow with water, do not chew adults and children 12 years and over: 1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (8 caplets) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of ...
Storage and handling
each caplet contains: calcium 54 mg salicylate 199 mg very 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 525 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
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
- swallow with water, do not chew
- adults and children 12 years and over:
- 1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea
- 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (8 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 54 mg
- salicylate 199 mg
- very 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® ULTRA
Bismuth Subsalicylate
Upset Stomach Reliever/
Antidiarrheal
2x CONCENTRATED FORMULA*
5 SYMPTOM RELIEF
NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA
24 CAPLETS
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 37000-478-12 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-416d-a910-e053-dadaa90a0b85 | Pepto Bismol ® ULTRA Caplets |
| 37000-478-24 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-416d-a910-e053-dadaa90a0b85 | Pepto Bismol ® ULTRA Caplets |
| 37000-478-12 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-416d-a910-e053-dadaa90a0b85 | Pepto Bismol ® ULTRA Caplets |
| 37000-478-24 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-416d-a910-e053-dadaa90a0b85 | Pepto Bismol ® ULTRA Caplets |
Products#
Every source-derived product name is available through these pages.
- Pepto-Bismol ULTRA
- Bismuth subsalicylate
- MAGNESIUM STEARATE
- MANNITOL
- CELLULOSE, MICROCRYSTALLINE
- POLYSORBATE 80
- POVIDONE
- D&C RED NO. 27
- D&C RED NO. 27 ALUMINUM LAKE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- SILICON DIOXIDE
- SALICYLIC ACID
- CALCIUM CARBONATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37000-478 | 37000-478-24, 37000-478-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 0ac2e94f-b293-d4fd-e063-6294a90a7c34 | 63274378-fbe1-63b1-e053-2a91aa0ae1a7 | 2023-11-22 | Warnings | 63274378-fbe1-63b1-e053-2a91aa0ae1a7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.