FDA.reportPublic FDA data

Extra Strength Gas Relief

Manufacturer
Shield Pharmaceuticals Corp
Effective date
2025-10-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:41:42

Label at a glance#

ProductExtra Strength Gas Relief
Active ingredientDIMETHICONE
Label structure12 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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, D&C Yellow #10, gelatin, glycerin, sorbitol solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-373-6981

Additional information

SPL UNCLASSIFIED SECTION

Extra Strength Gas ReliefSoftgels offer fast, effective relief of pressure and bloating that antacids can’t provide. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating, or discomfort referred to as gas.

Extra Strength Gas ReliefSoftgels are concentrated to contain liquid gas-fighting medicine in a small softgels so they are easy to swallow, and there is no chalky taste.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

SPL UNCLASSIFIED SECTION

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788

Made in India

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
Antigas

Relieves Gas Fast

  • Pressure
  • Bloating
  • Discomfort

Carton

Fas Relief CartonFas Relief Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198852simethicone 125 MG Oral CapsulePSN4
198852simethicone 125 MG Oral CapsuleSCD4
198852dimethicone 125 MG Oral CapsuleSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83059-0056-1Extra Strength Gas Relief15 in 1 BOTTLECAPSULE, LIQUID FILLED154
83059-0056-1Extra Strength Gas Relief1 in 1 CARTONCAPSULE, LIQUID FILLED14

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83059-005683059-0056-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-12-05full-release2026-06-01 00:43:14

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5877a046-756f-c95b-e063-6394a90aeb1d5f1dbf5e-a28a-4941-9bef-6584ecb787092026-08-07WarningsExact identifier
spl set id: 5f1dbf5e-a28a-4941-9bef-6584ecb78709

Reported adverse events (FAERS/openFDA)#

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