FDA.reportPublic FDA data

Extra Strength Gas Relief

Manufacturer
Shield Pharmaceuticals Corp
Effective date
2026-08-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-11 01:00:54

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 1, FD&C red #40, FD&C yellow #10, gelatin, glycerin, isopropyl alcohol, N-butyl alcohol, peppermint oil, propylene glycol, shellac, 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.

SPL UNCLASSIFIED SECTION

Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ValuRx

Extra Strength

Gas Relief
Simethicone 125 mg
Antigas

Carton

CartonCarton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130611419406217GTIN-13: 0611419406217
EAN-13: 0611419406217
GTIN-12: 611419406217
UPC-A: 611419406217
GTIN storage (14 digits): 00611419406217		Carton.jpg
QR code linkQR Codewww.shieldpharmacorp.com/Carton.jpg

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83059-016983059-0169-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
N-BUTYL ALCOHOL8PJ61P6TS3IACT
PEPPERMINT OILAV092KU4JHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
SORBITOL SOLUTION8KW3E207O2IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp55952af9-c3c1-452f-82c8-06f01dc4f0af2026-08-07WarningsExact identifier
ndc (package): 83059-0169-1
ndc (product): 83059-0169
ndc11 (package): 83059016901
spl id: 58782a7a-cf73-3719-e063-6394a90a2613
spl set id: 55952af9-c3c1-452f-82c8-06f01dc4f0af

Reported adverse events (FAERS/openFDA)#

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