Gas Relief

Manufacturer: United Natural Foods, Inc. dba UNFI
Effective date: 2025-11-19
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:16:56

Label at a glance#

ProductGas Relief Extra Strength

Active ingredientDIMETHICONE

Label structure10 sections

Indications and uses

for the relief of pressure, bloating, and fullness commonly referred to as gas.

Dosage and administration

adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Storage and handling

store between 20-25°C (68-77°F) do not refrigerate protect from light, heat, and moisture

Contacts and useful links#

PhoneLabel contact1-855-423-2630

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

for the relief of pressure, bloating, and fullness 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

store between 20-25°C (68-77°F)
do not refrigerate
protect from light, heat, and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-855-423-2630

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Gas-X® Extra Strength active ingredient†

extra strength

gas relief

simethicone 125 mg

(antigas)

relief of

bloating
pressure
discomfort

softgels

†This product is not manufactured or distributed by Haleon group of companies, distributor of Gas-X® Extra Strength.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02903

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198852	simethicone 125 MG Oral Capsule	PSN	7
198852	simethicone 125 MG Oral Capsule	SCD	7
198852	dimethicone 125 MG Oral Capsule	SY	7

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0041163245013	GTIN-13: 0041163245013 EAN-13: 0041163245013 GTIN-12: 041163245013 UPC-A: 041163245013 GTIN storage (14 digits): 00041163245013	gas-relief-125-mg-softgels-pat-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41163-597-30	Gas ReliefExtra Strength	1 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	1	7
41163-597-30	Gas ReliefExtra Strength	30 in 1 CARTON	CAPSULE, LIQUID FILLED	30	7
41163-597-50	Gas ReliefExtra Strength	50 in 1 CARTON	CAPSULE, LIQUID FILLED	50	7
41163-597-50	Gas ReliefExtra Strength	1 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41163-597-30	EA - Each	41163-597	656dab4b-fd5b-441c-b2cc-ab3a029b3822	1	2023-05-05

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Gas Relief Extra Strength
Simethicone
DIMETHICONE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
GLYCERIN
PEPPERMINT OIL
WATER
SORBITAN
SORBITOL
TITANIUM DIOXIDE
MANNITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41163-597	41163-597-30, 41163-597-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
WATER	059QF0KO0R	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
MANNITOL	3OWL53L36A	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 Extra Strength	SIMETHICONE	United Natural Foods, Inc. dba UNFI	bdd7147b-dcb4-4aa0-a3a1-ec9ceaeec787	2025-11-19	Warnings	Exact identifier ndc (package): 41163-597-30 ndc (package): 41163-597-50 ndc (product): 41163-597 ndc11 (package): 41163059730 ndc11 (package): 41163059750 spl id: b971d55f-ce7b-4ffb-8310-7163c3240b46 spl set id: bdd7147b-dcb4-4aa0-a3a1-ec9ceaeec787

Reported adverse events (FAERS/openFDA)#

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