FDA.reportPublic FDA data

Pepto-Bismol® Chewable Tablets

Manufacturer
Procter & Gamble Manufactura S de RL de CV
Effective date
2023-10-12
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:24:18

Label at a glance#

ProductPepto-Bismol
Active ingredientBISMUTH SUBSALICYLATE
Label structure20 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 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea  2 tablets (1 dose) every 1/2 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 • d...

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

Purpose

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

Do not use if

OTC - DO NOT USE SECTION

you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

When using this product

OTC - WHEN USING SECTION

a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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 1/2 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

TAMPER EVIDENT: Do not use if the printed inner wrap is broken or missing.

SPL UNCLASSIFIED SECTION

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 12 Chewable Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pepto
Bismol®

Bismuth Subsalicylate

Upset Stomach Reliever/ Antidiarrheal


CHEWABLES


5 SYMPTOM

RELIEF


NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

12 CHEWABLE TABLETS

477477

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58933-477-012021-06-10C16284748780-1ba0f9c33-375f-a910-e053-dadaa90a0b85Pepto-Bismol® Chewable Tablets
58933-477-092021-06-10C16284748780-1ba0f9c33-375f-a910-e053-dadaa90a0b85Pepto-Bismol® Chewable Tablets
58933-477-102021-06-10C16284748780-1ba0f9c33-375f-a910-e053-dadaa90a0b85Pepto-Bismol® Chewable Tablets
58933-477-122021-06-10C16284748780-1ba0f9c33-375f-a910-e053-dadaa90a0b85Pepto-Bismol® Chewable Tablets
58933-477-242021-06-10C16284748780-1ba0f9c33-375f-a910-e053-dadaa90a0b85Pepto-Bismol® Chewable Tablets
58933-477-012021-01-29C16284748780-1ba0f9c33-375f-a910-e053-dadaa90a0b85Pepto-Bismol® Chewable Tablets
58933-477-092021-01-29C16284748780-1ba0f9c33-375f-a910-e053-dadaa90a0b85Pepto-Bismol® Chewable Tablets
58933-477-102021-01-29C16284748780-1ba0f9c33-375f-a910-e053-dadaa90a0b85Pepto-Bismol® Chewable Tablets
58933-477-122021-01-29C16284748780-1ba0f9c33-375f-a910-e053-dadaa90a0b85Pepto-Bismol® Chewable Tablets
58933-477-242021-01-29C16284748780-1ba0f9c33-375f-a910-e053-dadaa90a0b85Pepto-Bismol® Chewable Tablets

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
58933-47758933-477-01, 58933-477-12, 58933-477-09, 58933-477-10, 58933-477-90

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
POVIDONEFZ989GH94EIACT
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
0b65eb42-1694-59cd-e063-6294a90a5e7b66d8f268-4e1e-5036-e053-2a91aa0a9de72023-11-30WarningsExact identifier
spl set id: 66d8f268-4e1e-5036-e053-2a91aa0a9de7

Reported adverse events (FAERS/openFDA)#

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