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
- 2019-12-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:51:11
Label at a glance#
ProductPepto-Bismol
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections
Dosage and administration
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 shake well before use use dose cup or tablespoon (TBSP) adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every ½ to 1 hour as needed do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours chew or dissolve in mouth adults and children 12 ye...
Storage and handling
protect from freezing. avoid excessive heat (over 104°F, 40°C). each 30 mL dose cup contains: magnesium 25 mg, sodium 8 mg salicylate 261 mg low sodium each tablet contains : calcium 90 mg, magnesium 8 mg salicylate 99 mg very low sodium
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredient (in each 30 mL dose cup) | Purposes |
| Bismuth subsalicylate 525 mg | Upset stomach reliever and antidiarrheal |
| Active ingredient (in each tablet) | |
| Bismuth subsalicylate 262 mg | 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
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
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
- 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
Liquid
- shake well before use
- use dose cup or tablespoon (TBSP)
- adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every ½ to 1 hour as needed
- do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours
Chewable Tablets
- chew or dissolve in mouth
- adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
- do not exceed 8 doses (16 tablets) in 24 hours
Other information
- protect from freezing.
- avoid excessive heat (over 104°F, 40°C).
Pepto-Bismol Liquid
- each 30 mL dose cup contains:
- magnesium 25 mg, sodium 8 mg
- salicylate 261 mg
- low sodium
Pepto-Bismol Chewable Tablets
- each tablet contains:
- calcium 90 mg, magnesium 8 mg
- salicylate 99 mg
- very low sodium
Inactive ingredients
Original Liquid
benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, magnesium aluminum silicate, methylcellulose, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, water
Chewable Tablets
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
Dist. by Procter & Gamble,
Cincinnati OH 45202
PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 37000-403-01
Pepto-
Bismol
™
BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER / ANTIDIARRHEAL
5
SYMPTOM
Digestive Relief
- heartburn
- indigestion
- nausea
- upset stomach
- diarrhea
TOTAL 24 FL OZ (708 ml) • TWO 12 FL OZ (354 ml) BOTTLES | 30 InstaCool ™ CHEWABLE TABLETS
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 37000-032-01 | ML - Milliliter | 37000-032 | da267f91-5557-440d-a2aa-49f443512014 | 1 | 2012-07-24 |
| 37000-032-02 | ML - Milliliter | 37000-032 | ac909b91-80ff-44c7-ae3d-d2c393307e52 | 1 | 2012-07-24 |
| 37000-032-03 | ML - Milliliter | 37000-032 | c596d31c-6bb1-4bd0-8ab0-502d17371596 | 1 | 2012-07-24 |
| 37000-032-04 | ML - Milliliter | 37000-032 | b22f64e7-3583-4511-8810-e8c2a23d41c9 | 1 | 2012-07-24 |
| 37000-691-30 | EA - Each | 37000-691 | 7bbf7670-e9e0-4d14-bf70-58316b25605a | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Bismuth Subsalicylate | ACTIVE INGREDIENT | 62TEY51RR1 | 2 | |
| Salicylic Acid | ACTIVE MOIETY | O414PZ4LPZ | 2 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | 2 | |
| benzoic acid | INACTIVE INGREDIENT | 8SKN0B0MIM | 2 | |
| calcium carbonate | INACTIVE INGREDIENT | H0G9379FGK | 2 | |
| D&C Red No. 22 | INACTIVE INGREDIENT | 1678RKX8RT | 2 | |
| D&C Red No. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 2 | |
| D&C Red No. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | 2 | |
| magnesium aluminum silicate | INACTIVE INGREDIENT | 6M3P64V0NC | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | 2 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | 2 | |
| saccharin sodium | INACTIVE INGREDIENT | SB8ZUX40TY | 2 | |
| salicylic acid | INACTIVE INGREDIENT | O414PZ4LPZ | 2 | |
| sodium salicylate | INACTIVE INGREDIENT | WIQ1H85SYP | 2 | |
| sorbic acid | INACTIVE INGREDIENT | X045WJ989B | 2 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- Pepto-Bismol
- Bismuth Subsalicylate
- BENZOIC ACID
- D&C RED NO. 22
- D&C RED NO. 28
- MAGNESIUM ALUMINUM SILICATE
- SACCHARIN SODIUM
- SALICYLIC ACID
- SODIUM SALICYLATE
- SORBIC ACID
- WATER
- BISMUTH CATION
- Pepto-Bismol INSTACOOL
- CALCIUM CARBONATE
- D&C RED NO. 27
- ALUMINUM OXIDE
- MAGNESIUM STEARATE
- MANNITOL
- POVIDONE
- TALC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37000-403 | 37000-403-01 |
| 37000-032 | 37000-032-03 |
| 37000-691 | 37000-691-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| povidones | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 616 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| sorbic acid | SORBIC ACID | X045WJ989B | CONCENTRATE / ORAL | 1 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| D&C Red No. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET / ORAL | 1 mg | ||
| povidones | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RESPIRATORY (INHALATION) | NA | ||
| sorbic acid | SORBIC ACID | X045WJ989B | TABLET, FILM COATED / ORAL | 5 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, DELAYED RELEASE / ORAL | 639 mg | ||
| benzoic acid | BENZOIC ACID | 8SKN0B0MIM | SUPPOSITORY / VAGINAL | 2 mg | ||
| sorbic acid | SORBIC ACID | X045WJ989B | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 1 mg | ||
| sorbic acid | SORBIC ACID | X045WJ989B | SUSPENSION / ORAL | 40 mg | ||
| sorbic acid | SORBIC ACID | X045WJ989B | GEL / TOPICAL | 2 mg | ||
| calcium carbonate | CALCIUM CARBONATE | H0G9379FGK | POWDER, DENTIFRICE / DENTAL | 0.5 mg/mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS | 180 mg | ||
| D&C Red No. 22 | D&C RED NO. 22 | 1678RKX8RT | SUSPENSION / ORAL | NA | ||
| sorbic acid | SORBIC ACID | X045WJ989B | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | CONCENTRATE / INTRAVENOUS | 220 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| D&C Red No. 28 | D&C RED NO. 28 | 767IP0Y5NH | CAPSULE / ORAL | 1 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | LOZENGE / ORAL | 20546 mg | ||
| magnesium aluminum silicate | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SUSPENSION / RECTAL | 14480 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING / ORAL | 80 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| magnesium aluminum silicate | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SHAMPOO / TOPICAL | 1.25 %w/w | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| talc | TALC | 7SEV7J4R1U | GRANULE / ORAL | 322 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / INTRAVENOUS | 15400 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 543 mg | ||
| sorbic acid | SORBIC ACID | X045WJ989B | EMULSION / OPHTHALMIC | 1 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | SOLUTION / OPHTHALMIC | 4.7 %w/v | ||
| povidones | POVIDONE | FZ989GH94E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 17 mg | ||
| talc | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| povidones | POVIDONE | FZ989GH94E | SUSPENSION/ DROPS / OPHTHALMIC | 0.6 %w/v | ||
| sorbic acid | SORBIC ACID | X045WJ989B | SOLUTION / OPHTHALMIC | 0.2 %w/v | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAVENOUS | 22 mg | ||
| povidones | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RECTAL | 665 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | GUM, CHEWING / BUCCAL | 891 mg | ||
| calcium carbonate | CALCIUM CARBONATE | H0G9379FGK | TABLET, FILM COATED / ORAL | 300 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET / BUCCAL | 360 mg | ||
| D&C Red No. 22 | D&C RED NO. 22 | 1678RKX8RT | TABLET, COATED / ORAL | NA | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| povidones | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| sorbic acid | SORBIC ACID | X045WJ989B | TABLET, DELAYED RELEASE / ORAL | 0.03 mg | ||
| talc | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| sorbic acid | SORBIC ACID | X045WJ989B | SYRUP / ORAL | 80 mg | ||
| talc | TALC | 7SEV7J4R1U | DROPS / ORAL | NA | ||
| calcium carbonate | CALCIUM CARBONATE | H0G9379FGK | SOLUTION / AURICULAR (OTIC) | 0.38 %w/w | ||
| benzoic acid | BENZOIC ACID | 8SKN0B0MIM | LOTION / TOPICAL | 0.2 %w/w |
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 |
|---|---|---|---|---|---|---|
| 99d751d0-43aa-2249-e053-2995a90a183f | 854c803e-5edb-4e94-bc84-77b35fc69225 | 2019-12-16 | Warnings | 99d751d0-43aa-2249-e053-2995a90a183f 854c803e-5edb-4e94-bc84-77b35fc69225 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.