FDA.reportPublic FDA data

Pepto Bismol Fast Melts Fresh Berry Flavored

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-09-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-09-11 03:01:17

Label at a glance#

ProductPepto Bismol Fast Melts Fresh Berry Flavored
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

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

Storage and handling

each soft chewable tablet contains:  •  calcium 55 mg  • salicylate 100 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 soft 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: 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

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

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.

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 soft chewable tablets every 1/2 hour or 4 soft chewable tablets every hour as needed for diarrhea

    • 2 soft chewable tablets every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

  • do not exceed 8 doses (16 soft 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 soft chewable tablet contains:  • calcium 55 mg  • salicylate 100 mg  • low sodium
  • Store at no greater than 25°C.  Avoid excessive heat (over 40°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, carrageenan, corn syrup, FD&C Red No. 40, flavor, hydrogenated coconut oil, soy lecithin, sucrose, water

Questions?

OTC - QUESTIONS SECTION

1-800-717-3786

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF INNER PRINTED SEAL ON BOTTLE IS BROKEN OR MISSING.

SPL UNCLASSIFIED SECTION

DIST. BY: PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 24 SOFT CHEWABLE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pepto Bismol®

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

FAST MELTS

5 SYMPTOM RELIEF

FRESH BERRY FLAVORED

24 SOFT CHEWABLE TABLETS

831831

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130301490002827GTIN-13: 0301490002827
EAN-13: 0301490002827
GTIN-12: 301490002827
UPC-A: 301490002827
GTIN storage (14 digits): 00301490002827		831.jpg
Data codeData Matrix21130554831.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-83169423-831-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CALCIUM CARBONATEH0G9379FGKIACT
CARRAGEENAN5C69YCD2YJIACT
CORN SYRUP9G5L16BK6NIACT
FD&C RED NO. 40WZB9127XOAIACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-10-03full-release2026-06-01 01:15:42
32025-08-05legacy-cache2026-10-22 23:46:30

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 Fast Melts Fresh Berry FlavoredBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Company039391d0-9ec1-45a3-84fa-b5f591794e412026-09-08WarningsExact identifier
ndc (package): 69423-831-24
ndc (product): 69423-831
ndc11 (package): 69423083124
spl id: 5afdfe7c-298d-b306-e063-6294a90a5c5c
spl set id: 039391d0-9ec1-45a3-84fa-b5f591794e41

Reported adverse events (FAERS/openFDA)#

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