Pepto
Pepto Gas + Bloating
Approved
Approval ID
3d80a5bb-0ed0-769a-e063-6394a90ac50c
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Oct 1, 2025
Manufacturers
FDA
The Procter & Gamble Manufacturing Company
DUNS: 004238200
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Simethicone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code84126-368
Application NumberM002
Product Classification
M
Marketing Category
C200263
G
Generic Name
Simethicone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2025
FDA Product Classification
INGREDIENTS (6)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DIMETHICONEActive
Quantity: 250 mg in 1 1
Code: 92RU3N3Y1O
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 10/1/2025
PRINCIPAL DISPLAY PANEL - 50 Softgels Carton
Simethicone 250 mg Antigas
Pepto Gas + Bloating
TARGETED RELIEF
BLOATING
DISCOMFORT
PRESSURE
MAX STRENGTH
RELIEVES GAS FAST
50 SOFTGELS
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 10/1/2025
Uses
relieves
- bloating, pressure, fullness and stuffed feeling, commonly referred to as gas
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 10/1/2025
Active ingredient (in each softgel)
Simethicone 250 mg
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 10/1/2025
Purpose
Antigas
WARNINGS SECTION
LOINC: 34071-1Updated: 10/1/2025
Warnings
If pregnant or breast feeding,
ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 10/1/2025
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 10/1/2025
Directions
- 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 SECTION
LOINC: 44425-7Updated: 10/1/2025
Other information
- store at room temperature 20°-25°C (68°-77ºF)
- protect from light
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 10/1/2025
Inactive ingredients
D&C Red No. 33, gelatin, glycerin, silicon dioxide, water
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 10/1/2025
Questions?
1-800-717-3786
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 10/1/2025
MADE IN CANADA
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202