Extra Strength Gas Relief

Manufacturer: Shield Pharmaceuticals Corp
Effective date: 2026-07-15
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: daily-update
Hydrated at: 2026-07-18 05:11:11

Label at a glance#

ProductExtra Strength Gas Relief

Active ingredientDIMETHICONE

Label structure8 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

Contacts and useful links#

PhoneLabel contact1-800-373-6981

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

OTHER SAFETY INFORMATION

store at controlled room temperature 20-25ºC (68-77ºF)
protect from light, heat, and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD & C blue #01, FD&C red #40,D&C yellow #10, gelatin, glycerin, peppermint oil, sorbitol solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-373-6981

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ValuRx
Compare to the active ingredient in Extra Strength Gas-X®

Extra Strength Gas Relief
Simethicone 125 mg

Label

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
83059-0096	83059-0096-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
SORBITOL SOLUTION	8KW3E207O2	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
2	2026-05-13	full-release	2026-06-01 01:57:24

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
59fc23e6-a625-bed5-e063-6294a90ab0cf			e62f6f6f-59a9-4df4-91ca-a76c4de93fe0	2026-08-26	Warnings	Exact identifier spl set id: e62f6f6f-59a9-4df4-91ca-a76c4de93fe0

Reported adverse events (FAERS/openFDA)#

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