FDA.reportPublic FDA data

Pepto

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-10-09 01:01:35

Label at a glance#

ProductPepto Gas plus Bloating
Active ingredientDIMETHICONE
Label structure13 sections

Indications and uses

relieves bloating, pressure, fullness and stuffed feeling, commonly referred to as gas

Dosage and administration

adults and children 12 years and over: swallow 1-2 softgels as needed (or as symptoms occur) after a meal or at bedtime do not exceed 2 softgels in 24 hours unless directed by a doctor

Storage and handling

store at room temperature 20°-25°C (68°-77ºF) protect from light

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

relieves

  • bloating, pressure, fullness and stuffed feeling, commonly referred to as gas

Warnings

WARNINGS SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: swallow 1-2 softgels as needed (or as symptoms occur) after a meal or at bedtime
  • do not exceed 2 softgels in 24 hours unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 20°-25°C (68°-77ºF)
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 33, gelatin, glycerin, silicon dioxide, water

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

MADE IN CANADA

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 50 Softgels Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Simethicone 250 mg Antigas

Pepto Gas + Bloating

TARGETED RELIEF

BLOATING

DISCOMFORT

PRESSURE

MAX STRENGTH

RELIEVES GAS FAST

50 SOFTGELS

368368

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130301490004005GTIN-13: 0301490004005
EAN-13: 0301490004005
GTIN-12: 301490004005
UPC-A: 301490004005
GTIN storage (14 digits): 00301490004005		368.jpg
Data codeData Matrix21397735368.jpg

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-36884126-368-50, 84126-368-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
GELATIN2G86QN327LIACT
WATER059QF0KO0RIACT
D&C RED NO. 339DBA0SBB0LIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-09-10daily-update2026-09-12 01:01:07
12025-10-01full-release2026-06-01 01:15:15

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
5b22dd76-be2d-0a31-e063-6294a90a08f43d80a5bb-0ed0-769a-e063-6394a90ac50c2026-09-10WarningsExact identifier
spl set id: 3d80a5bb-0ed0-769a-e063-6394a90ac50c

Reported adverse events (FAERS/openFDA)#

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