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
- Lil' Drug Store Products, Inc.
- Effective date
- 2023-07-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-05-31 23:55:41
Label at a glance#
ProductPepto Bismol
Active ingredientBISMUTH SUBSALICYLATE
Label structure11 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 ½ 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 c...
Storage and handling
each tablet contains: calcium 140 mg, magnesium 9 mg salicylate 99 mg low sodium avoid excessive heat (over 104°F or 40°C)
Contacts and useful links#
Label contents#
Full prescribing information#
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
- 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
- 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 ½ 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 99 mg
- low sodium
- avoid excessive heat (over 104°F or 40°C)
Inactive Ingredients
adipic acid, calcium carbonate, D&C Red No. 27 aluminum lake, FD&C Red No. 40 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc
Questions?
1-800-717-3786
SPL UNCLASSIFIED SECTION
PRODUCT REPACKAGED AND DISTRIBUTED WITH PERMISSION OF MANUFACTURER BY:
Convenience Valet® Glendale Heights, IL 60139 1-800-351-2000 (8:30 AM - 5:00 PM CST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Pepto Bismol
Bismuth Subsalicylate
Upset Stomach Reliever/Antidiarrheal
CHEWABLES
5 SYMPTOM RELIEF
NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA
4 CHEWABLE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Pepto Bismol
Bismuth Subsalicylate
Upset Stomach Reliever/Antidiarrheal
CHEWABLES
5 SYMPTOM RELIEF
NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA
6 CHEWABLE TABLETS
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 29485-1531 | PEPTO BISMOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.] | 6 | Legacy NDC | 20230720_d04e42bf-2748-f12b-e053-2a95a90a35e5.zip |
| 29485-6754 | PEPTO BISMOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.] | 6 | Legacy NDC | 20230720_d04e42bf-2748-f12b-e053-2a95a90a35e5.zip |
Products#
Every source-derived product name is available through these pages.
- Pepto Bismol
- BISMUTH SUBSALICYLATE
- MANNITOL
- TALC
- CALCIUM CARBONATE
- MAGNESIUM STEARATE
- POVIDONE, UNSPECIFIED
- SALICYLIC ACID
- D&C RED NO. 27 ALUMINUM LAKE
- SACCHARIN SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 29485-1531 | 29485-1531-4 |
| 29485-6754 | 29485-6754-6 |
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 |
|---|---|---|---|---|---|---|
| 00d86cb8-f8f0-e7e2-e063-6294a90add1d | d04e42bf-2748-f12b-e053-2a95a90a35e5 | 2023-07-19 | Warnings | 00d86cb8-f8f0-e7e2-e063-6294a90add1d d04e42bf-2748-f12b-e053-2a95a90a35e5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.