FDA.reportPublic FDA data

Pepto-Bismol

Manufacturer
A-S Medication Solutions
Effective date
2023-02-04
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-05-31 23:53:45

Label at a glance#

ProductPepto-Bismol
Active ingredientBISMUTH SUBSALICYLATE
Label structure12 sections

Indications and uses

relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness

Dosage and administration

chew or dissolve in mouth adults and children 12 years and over: 2 tablets (1 dose) every ½ 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 cle...

Storage and handling

each tablet contains : calcium 140 mg, magnesium 9 mg salicylate 101 mg low sodium avoid excessive heat (over 104°F or 40°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purposes

OTC - PURPOSE SECTION

Upset stomach reliever and antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • chew or dissolve in mouth
  • adults and children 12 years and over:
  • 2 tablets (1 dose) every ½ 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

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 140 mg, magnesium 9 mg
  • salicylate 101 mg
  • low sodium
  • avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

Questions?

OTC - QUESTIONS SECTION

1-800-717-3786

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble, Cincinnati OH 45202

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-0553

NDC: 50090-0553-0 6 TABLET in a CELLO PACK / 5 in a CARTON

Bismuth subsalicylate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN17
211151Pepto-Bismol 262 MG Chewable TabletPSN17
211151bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]SBD17
308761bismuth subsalicylate 262 MG Chewable TabletSCD17
211151Pepto-bismol 262 MG Chewable TabletSY17
211151Pepto-Bismol InstaCool 262 MG Chewable TabletSY17
211151Pepto-Bismol To-Go 262 MG Chewable TabletSY17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0553-02025-01-30C16284748780-1f386c64a-459f-0266-e053-dadaa90a7c1aPepto-Bismol™
50090-0553-02023-02-07C16284748780-1f386c64a-459f-0266-e053-dadaa90a7c1aPepto-Bismol™
50090-0553-02023-01-30C16284748780-1f386c64a-459f-0266-e053-dadaa90a7c1aPepto-Bismol™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0553-0Pepto-Bismol6 in 1 CELLO PACKTABLET617
50090-0553-0Pepto-Bismol5 in 1 CARTONTABLET517

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0553PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [A-S MEDICATION SOLUTIONS]17Legacy NDC, 2 package rows20230208_e02bead2-0be9-41b0-98a7-fd0c3f57def0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0553-0EA - Each50090-0553f53d9a8a-fa2a-4c35-aed3-f1eecf4d494212024-08-12
37000-477-09EA - Each37000-4770242e6e2-de1b-426d-afce-d5e27e0ea3b012015-10-02
37000-477-10EA - Each37000-477e4fa3a27-8011-4582-8a10-be0ed001120b12015-10-02
37000-477-12EA - Each37000-477de063b90-0b74-4b42-881b-efa0a8f316e612015-10-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-055350090-0553-0
37000-477

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TALC7SEV7J4R1UIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
646925a5-98cc-40af-82e0-bdb3cbc412fee02bead2-0be9-41b0-98a7-fd0c3f57def02023-02-04WarningsExact identifier
spl id: 646925a5-98cc-40af-82e0-bdb3cbc412fe
spl set id: e02bead2-0be9-41b0-98a7-fd0c3f57def0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.