FDA.reportPublic FDA data

Gas Relief Extra Strength

Manufacturer
TOPCO ASSOCIATES LLC
Effective date
2024-12-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:50:59

Label at a glance#

ProductGas Relief Extra Strength
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure11 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) protect from heat and moisture

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

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)
  • protect from heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10, edible white ink, FD&C blue #1, FD&C red #40, gelatin. glycerin, light mineral oil, peppermint oil, purified water, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call 1-888-423-0139

SPL UNCLASSIFIED SECTION

TopCare® health

COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*

FAST RELIEF OF:

  • Bloating
  • Pressure
  • Fullness & Gas

DISTRIBUTED BY TOPCO ASSOCIATES LLC,
ELK GROVE VILLAGE, IL 60007
©TOPCO STVA0122
topcare@topco.com www.topcarebrand.com

This TopCare® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

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

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

KEEP OUTER CARTON FOR COMPLETE PRODUCT INFORMATION

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 50 Softgel Blister Pack CartonPRINCIPAL DISPLAY PANEL - 50 Softgel Blister Pack 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
36800-785-05Gas Relief Extra Strength25 in 1 BLISTER PACKCAPSULE, LIQUID FILLED254
36800-785-05Gas Relief Extra Strength2 in 1 CARTONCAPSULE, LIQUID FILLED24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-785GAS RELIEF EXTRA STRENGTH (DIMETHICONE) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 2 package rows20250108_bb1c54d4-3a36-4b77-8659-2e92845d2f0e.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-78536800-785-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
LIGHT MINERAL OILN6K5787QVPIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
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
Gas Relief Extra StrengthDIMETHICONETOPCO ASSOCIATES LLCbb1c54d4-3a36-4b77-8659-2e92845d2f0e2024-12-14WarningsExact identifier
ndc (package): 36800-785-05
ndc (product): 36800-785
ndc11 (package): 36800078505
spl id: f5355dba-155d-4cb7-bc7d-7d2a86ded05d
spl set id: bb1c54d4-3a36-4b77-8659-2e92845d2f0e

Reported adverse events (FAERS/openFDA)#

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