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
- 2021-02-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:52:57
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 104ºF, 40ºC) each 30 mL dose cup contains: magnesium 25 mg, sodium 8 mg salicylate 261 mg low sodium each tablet contains : calcium 140 mg, magnesium 9 mg salicylate 101 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
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
OTC - WHEN USING SECTION
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur
OTC - STOP USE SECTION
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 104ºF, 40ºC)
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 140 mg, magnesium 9 mg
- salicylate 101 mg
- very low sodium
Inactive ingredients
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 37000-402-01
Pepto-
Bismol
™
BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER/ANTIDIARRHEAL
5
SYMPTOM
Digestive Relief
- heartburn
- indigestion
- nausea
- upset stomach
- diarrhea
TOTAL 32 FL OZ (946 ml) • TWO 16 FL OZ (473 ml) BOTTLES | 48 CHEWABLE TABLETS
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 37000-402-01 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-3cff-a910-e053-dadaa90a0b85 | Pepto-Bismol ™ |
| 37000-402-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3cff-a910-e053-dadaa90a0b85 | Pepto-Bismol ™ |
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 |
| 37000-477-09 | EA - Each | 37000-477 | 0242e6e2-de1b-426d-afce-d5e27e0ea3b0 | 1 | 2015-10-02 |
| 37000-477-10 | EA - Each | 37000-477 | e4fa3a27-8011-4582-8a10-be0ed001120b | 1 | 2015-10-02 |
| 37000-477-12 | EA - Each | 37000-477 | de063b90-0b74-4b42-881b-efa0a8f316e6 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Bismuth Subsalicylate | ACTIVE INGREDIENT | 62TEY51RR1 | 3 | |
| salicylic acid | ACTIVE MOIETY | O414PZ4LPZ | 3 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | 3 | |
| benzoic acid | INACTIVE INGREDIENT | 8SKN0B0MIM | 3 | |
| calcium carbonate | INACTIVE INGREDIENT | H0G9379FGK | 3 | |
| D&C Red No. 22 | INACTIVE INGREDIENT | 1678RKX8RT | 3 | |
| D&C Red No. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 3 | |
| D&C Red No. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | 3 | |
| magnesium aluminum silicate | INACTIVE INGREDIENT | 6M3P64V0NC | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | 3 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | 3 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | 3 | |
| saccharin sodium | INACTIVE INGREDIENT | SB8ZUX40TY | 3 | |
| salicylic acid | INACTIVE INGREDIENT | O414PZ4LPZ | 3 | |
| sodium salicylate | INACTIVE INGREDIENT | WIQ1H85SYP | 3 | |
| sorbic acid | INACTIVE INGREDIENT | X045WJ989B | 3 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
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
- CALCIUM CARBONATE
- D&C RED NO. 27
- ALUMINUM OXIDE
- MAGNESIUM STEARATE
- MANNITOL
- POVIDONE
- TALC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37000-402 | 37000-402-01 |
| 37000-032 | 37000-032-04 |
| 37000-477 | 37000-477-10 |
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 |
|---|---|---|---|---|---|---|
| sorbic acid | SORBIC ACID | X045WJ989B | CONCENTRATE / ORAL | 1 mg | ||
| talc | TALC | 7SEV7J4R1U | PELLET / ORAL | 69 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 658 mg | ||
| benzoic acid | BENZOIC ACID | 8SKN0B0MIM | ELIXIR / ORAL | 90 mg | ||
| D&C Red No. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, CHEWABLE / ORAL | 7 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | GEL / OPHTHALMIC | 25 mg | ||
| povidones | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | SUSPENSION/ DROPS / OPHTHALMIC | 3.3 %w/v | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FILM COATED / ORAL | 2 mg | ||
| sorbic acid | SORBIC ACID | X045WJ989B | LOTION / TOPICAL | 4 mg | ||
| povidones | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| talc | TALC | 7SEV7J4R1U | CAPSULE / ORAL | 729 mg | ||
| D&C Red No. 28 | D&C RED NO. 28 | 767IP0Y5NH | POWDER, FOR SOLUTION / ORAL | 3 mg | ||
| calcium carbonate | CALCIUM CARBONATE | H0G9379FGK | CAPSULE / ORAL | 349.9 mg | ||
| povidones | POVIDONE | FZ989GH94E | INJECTION / INTRAMUSCULAR | 0.2 %w/v | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RESPIRATORY (INHALATION) | NA | ||
| talc | TALC | 7SEV7J4R1U | SUSPENSION, EXTENDED RELEASE / ORAL | 46 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / DENTAL | 0.3 %w/w | ||
| talc | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| povidones | POVIDONE | FZ989GH94E | TABLET, FOR SUSPENSION / ORAL | 2 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | SOLUTION / OPHTHALMIC | 4.7 %w/v | ||
| D&C Red No. 28 | D&C RED NO. 28 | 767IP0Y5NH | TABLET / ORAL | NA | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, FOR SUSPENSION / ORAL | 7621 mg | ||
| talc | TALC | 7SEV7J4R1U | GRANULE / ORAL | 322 mg | ||
| D&C Red No. 28 | D&C RED NO. 28 | 767IP0Y5NH | CAPSULE, DELAYED RELEASE / ORAL | 1 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 164 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 35 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| benzoic acid | BENZOIC ACID | 8SKN0B0MIM | CREAM / TOPICAL | 6 mg | ||
| talc | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| talc | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| benzoic acid | BENZOIC ACID | 8SKN0B0MIM | SUPPOSITORY / VAGINAL | 2 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, ORALLY DISINTEGRATING / ORAL | 4364 mg | ||
| povidones | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / BUCCAL | 0.4 mg | ||
| povidones | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| talc | TALC | 7SEV7J4R1U | SUSPENSION / ORAL | 234 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET / ORAL | 3391 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, EXTENDED RELEASE / ORAL | 1086 mg | ||
| D&C Red No. 22 | D&C RED NO. 22 | 1678RKX8RT | CAPSULE, EXTENDED RELEASE / ORAL | NA | ||
| D&C Red No. 28 | D&C RED NO. 28 | 767IP0Y5NH | CAPSULE / ORAL | 1 mg | ||
| povidones | POVIDONE | FZ989GH94E | TABLET, EXTENDED RELEASE / ORAL | 101 mg | ||
| povidones | POVIDONE | FZ989GH94E | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| mannitol | MANNITOL | 3OWL53L36A | GRANULE / ORAL | 1328 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / DENTAL | 0.05 %w/v | ||
| D&C Red No. 22 | D&C RED NO. 22 | 1678RKX8RT | CAPSULE / ORAL | 0.02 mg | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | SPONGE / TOPICAL | NA | ||
| talc | TALC | 7SEV7J4R1U | TABLET / RECTAL | 32.4 mg | ||
| povidones | POVIDONE | FZ989GH94E | POWDER, FOR SUSPENSION / ORAL | 35 mg/5ml | ||
| magnesium aluminum silicate | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | POWDER, FOR SUSPENSION / ORAL | NA | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / TOPICAL | NA | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, DELAYED RELEASE / ORAL | 639 mg | ||
| sorbic acid | SORBIC ACID | X045WJ989B | TABLET, FILM COATED / ORAL | 5 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| calcium carbonate | CALCIUM CARBONATE | H0G9379FGK | TABLET / ORAL | 793 mg |
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 |
|---|---|---|---|---|---|---|
| e5f87a3f-bd5d-f98b-e053-2a95a90a83fb | 33baaf04-498d-44f2-9288-02b8f874f914 | 2022-08-11 | Warnings | 33baaf04-498d-44f2-9288-02b8f874f914 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.