FDA.reportPublic FDA data

Pepto Bismol

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
daily-update
Hydrated at
2026-10-09 01:02:01

Label at a glance#

ProductPepto Bismol Chews
Active ingredientBISMUTH SUBSALICYLATE
Label structure21 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

fully chew before swallowing adults and children 12 years and over: 2 chewable tablets every ½ hour or 4 chewable tablets every hour as needed for diarrhea 2 chewable tablets every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 chewable tablets) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a docto...

Storage and handling

each chewable tablet contains: calcium 50 mg • salicylate 117 mg low sodium Store at no greater than 25°C. Avoid excessive heat (over 40°C.)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable 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 you have

OTC - DO NOT USE SECTION

  • 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

  • fully chew before swallowing
  • adults and children 12 years and over:
  • 2 chewable tablets every ½ hour or 4 chewable tablets every hour as needed for diarrhea
  • 2 chewable tablets every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 chewable 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 chewable tablet contains:
  • calcium 50 mg • salicylate 117 mg
  • low sodium
  • Store at no greater than 25°C. Avoid excessive heat (over 40°C.)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, anhydrous citric acid, calcium carbonate, caprylic/capric triglyceride, carmine, carnauba wax, corn starch, corn syrup, dextrin, FD&C Blue No. 2 Aluminum Lake, flavors, hydrogenated coconut oil, maltodextrin, potassium hydroxide, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, water, white wax

Questions?

OTC - QUESTIONS SECTION

1-800-717-3786

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 24 Chewable Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bismuth Subsalicylate

Upset Stomach Reliever

Antidiarrheal

Pepto Bismol ®

CHEWS

BERRY MINT FLAVORED

24 CHEWABLE TABLETS

963963

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130301490003770GTIN-13: 0301490003770
EAN-13: 0301490003770
GTIN-12: 301490003770
UPC-A: 301490003770
GTIN storage (14 digits): 00301490003770		963.jpg
Data codeData Matrix21241896963.jpg
Data codeData Matrix21471836963.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-96369423-963-24, 69423-963-72, 69423-963-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
FD&C BLUE NO. 2 ALUMINUM LAKE4AQJ3LG584IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBIC ACIDX045WJ989BIACT
SORBITOL506T60A25RIACT
ICODEXTRIN2NX48Z0A9GIACT
ACACIA5C5403N26OIACT
CALCIUM CARBONATEH0G9379FGKIACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
CARNAUBA WAXR12CBM0EIZIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
STARCH, CORNO8232NY3SJIACT
CORN SYRUP9G5L16BK6NIACT
MALTODEXTRIN7CVR7L4A2DIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
SHELLAC46N107B71OIACT
SODIUM BENZOATEOJ245FE5EUIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SUCROSEC151H8M554IACT
CARMINIC ACIDCID8Z8N95NIACT
WATER059QF0KO0RIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
WHITE WAX7G1J5DA97FIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
152026-07-27daily-update2026-07-29 05:10:10
142025-11-06full-release2026-06-01 01:42:43
132025-10-03full-release2026-06-01 01:15:52

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
Pepto Bismol ChewsBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Companycfe9214d-25e9-7729-e053-2a95a90a0dfb2026-07-27WarningsExact identifier
ndc (package): 69423-963-72
ndc (package): 69423-963-24
ndc (package): 69423-963-48
ndc (product): 69423-963
ndc11 (package): 69423096372
ndc11 (package): 69423096348
ndc11 (package): 69423096324
spl set id: cfe9214d-25e9-7729-e053-2a95a90a0dfb

Reported adverse events (FAERS/openFDA)#

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