Gas Relief
Drug Facts
Approved
Approval ID
544106bc-3c80-4d43-9df3-61a931d1751e
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Sep 22, 2025
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
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 Code68788-7890
Application NumberM002
Product Classification
M
Marketing Category
C200263
G
Generic Name
Simethicone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2025
FDA Product Classification
INGREDIENTS (5)
DIMETHICONE, UNSPECIFIEDActive
Quantity: 180 mg in 1 1
Code: 92RU3N3Y1O
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 9/22/2025
Product Label
RUGBY LABORATORIES Ultra Strength Simethicone
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 9/22/2025
Uses
•
relieves bloating, pressure, or fullness commonly referred to as gas
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 9/22/2025
Active ingredient (in each softgel)
Simethicone 180 mg
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 9/22/2025
Purpose
Antigas
WARNINGS SECTION
LOINC: 34071-1Updated: 9/22/2025
Warnings
Stop use and ask a doctor if
condition persists.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 9/22/2025
Directions
•
swallow one or two softgels as symptoms occur
•
do not exceed two softgels per 24 hours except under the advice and supervision of a physician
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 9/22/2025
Other information
•
store between 15-30ºC (59-86ºF)
•
protect from heat and moisture
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 9/22/2025
Inactive ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 9/22/2025
Questions or comments?
Call1-800-645-2158