FDA.reportPublic FDA data

ULTRA STRENGTH Gas Relief Softgels

Manufacturer
Topco Associates LLC
Effective date
2025-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:27:45

Label at a glance#

ProductULTRA STRENGTH Gas Relief Softgels
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

• store at controlled room temperature 20-25°C (68-77°F) • protect from light, heat, and moisture

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

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

Warnings

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

• store at controlled room temperature 20-25°C (68-77°F)
• protect from light, heat, and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, black iron oxide, FD&C Yellow No. 6, gelatin, glycerin, isopropyl alcohol, n-butyl alcohol, peppermint oil, propylene glycol, shellac glaze, sorbitol sorbitan anhydrous, titanium dioxide

Questions or comments? 

OTC - QUESTIONS SECTION

Call 1-888-423-0139

SPL UNCLASSIFIED SECTION

COMPARE TO GAS-X® ULTRA STRENGTH ACTIVE INGREDIENT*

FAST RELIEF OF:
• Bloating
• Pressure
• Fullness & Gas

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143
©TOPCO STVA0925
topcare@topco.com     www.topcarebrand.com
PRODUCT OF INDIA

QUALITY GUARANTEED

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X®.

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ULTRA STRENGTH Gas Relief SoftgelsULTRA STRENGTH Gas Relief Softgels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252294simethicone 180 MG Oral CapsulePSN2
252294simethicone 180 MG Oral CapsuleSCD2
252294dimethicone 180 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codetopbrnds.com/mTGV3K76162840-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-840-05ULTRA STRENGTH Gas Relief Softgels25 in 1 BLISTER PACKCAPSULE, LIQUID FILLED252
76162-840-05ULTRA STRENGTH Gas Relief Softgels2 in 1 CARTONCAPSULE, LIQUID FILLED22

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-84076162-840-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
AMMONIA5138Q19F1XIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
BUTYL ALCOHOL8PJ61P6TS3IACT
PEPPERMINT OILAV092KU4JHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT
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
ULTRA STRENGTH Gas Relief SoftgelsSIMETHICONETopco Associates LLC42c449cc-a450-1796-e063-6294a90a762a2025-12-13WarningsExact identifier
ndc (package): 76162-840-05
ndc (product): 76162-840
ndc11 (package): 76162084005
spl id: acddc122-3fe4-4a46-ae05-463ed8e16257
spl set id: 42c449cc-a450-1796-e063-6294a90a762a

Reported adverse events (FAERS/openFDA)#

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