FDA.reportPublic FDA data

TopCare health EXTRA STRENGTH Gas Relief SOFTGEL

Manufacturer
Topco Associates LLC
Effective date
2025-08-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:09:39

Label at a glance#

ProductTopCare health EXTRA STRENGTH Gas Relief SOFTGEL
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure10 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 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 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 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, D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, isopropyl alcohol, N-butyl alcohol, peppermint oil, propylene glycol, shellac glaze, sorbitol sorbitan solution, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call 1-888-423-0139

SPL UNCLASSIFIED SECTION

COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*

FAST RELIEF OF:

  • Bloating
  • Pressure
  • Fullness & Gas

KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143 ©TOPCO STVA0425

topcare@topco.com   www.topcarebrand.com

PRODUCT OF INDIA

*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Gas-X®.

QUALITY GUARANTEED

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

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

TCGasReliefTCGasRelief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198852simethicone 125 MG Oral CapsulePSN2
198852simethicone 125 MG Oral CapsuleSCD2
198852dimethicone 125 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-538-05TopCare health EXTRA STRENGTH Gas Relief SOFTGEL2 in 1 CARTONCAPSULE, LIQUID FILLED22
76162-538-05TopCare health EXTRA STRENGTH Gas Relief SOFTGEL25 in 1 BLISTER PACKCAPSULE, LIQUID FILLED252

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-53876162-538-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
AMMONIA5138Q19F1XIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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
TopCare health EXTRA STRENGTH Gas Relief SOFTGELSIMETHICONETopco Associates LLC2ea0eb22-f679-d136-e063-6294a90a1dfe2025-08-01WarningsExact identifier
ndc (package): 76162-538-05
ndc (product): 76162-538
ndc11 (package): 76162053805
spl id: 3e0ea0d4-f46d-47be-b087-7e4538b22915
spl set id: 2ea0eb22-f679-d136-e063-6294a90a1dfe

Reported adverse events (FAERS/openFDA)#

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