Gas Relief

Manufacturer: Rugby Laboratories, Inc.
Effective date: 2025-07-18
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 01:07:46

Label at a glance#

ProductGas Relief Ultra Strength

Active ingredientDIMETHICONE

Label structure10 sections

Indications and uses

relieves bloating, pressure, or fullness commonly referred to as gas

Dosage and administration

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

store between 15-30ºC (59-86ºF) protect from heat and moisture

Contacts and useful links#

PhoneLabel contact1-800-645-2158

Websitewww.rugbylaboratories.om

www.rugbylaboratories.om

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 180 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

relieves bloating, pressure, or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

store between 15-30ºC (59-86ºF)
protect from heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6, gelatin, glycerin

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-645-2158

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Phazyme® Ultra Strength†

Ultra Strength

Simethicone 180 mg

Antigas

Fast relief of

Gas
Pressure
Bloating
Discomfort

†This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme® Ultra Strength

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

RUGBY® LABORATORIES

Livonia, MI 48152

www.rugbylaboratories.om

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
252294	simethicone 180 MG Oral Capsule	PSN	6
252294	simethicone 180 MG Oral Capsule	SCD	6
252294	dimethicone 180 MG Oral Capsule	SY	6

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0536-1306-08	Gas ReliefUltra Strength	60 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	60		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1306-08	EA - Each	0536-1306	c6363f4f-d9fb-4f82-9a97-175d5030737e	1	2021-03-02

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Gas Relief Ultra Strength
Simethicone
DIMETHICONE
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
FD&C RED NO. 40

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0536-1306	0536-1306-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
FD&C RED NO. 40	WZB9127XOA	IACT

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gas Relief Ultra Strength	SIMETHICONE	Rugby Laboratories, Inc.	24731f4b-ca2b-483f-beed-dfc8104f8133	2025-07-18	Warnings	Exact identifier ndc (package): 0536-1306-08 ndc (product): 0536-1306 ndc11 (package): 00536130608 spl id: 4048f848-c559-402b-948d-5bbdca0c637e spl set id: 24731f4b-ca2b-483f-beed-dfc8104f8133

Reported adverse events (FAERS/openFDA)#

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