Topco Extra Strength Gas Relief Tablets

Manufacturer: Topco Associates, LLC | Guardian Drug Company
Effective date: 2024-12-26
Label type: Human OTC Drug Label
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:49:18

Label at a glance#

ProductGas Relief

Active ingredientDIMETHICONE

Label structure9 sections

Dosage and administration

chew 1 to 2 tablets thoroughly as needed after meals and at bedtime do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

Storage and handling

do not use if any individual blister unit is broken or open store at room temperature avoid high humidity and excessive heat, above 40ºC (104ºF)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

PURPOSE

OTC - PURPOSE SECTION

Anti-gas

USE(S)

INDICATIONS & USAGE SECTION

relieves:

pressure
bloating
symptoms referred to as gas

WARNINGS

WARNINGS SECTION

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a poison control center immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

OTHER INFORMATION

STORAGE AND HANDLING SECTION

do not use if any individual blister unit is broken or open
store at room temperature
avoid high humidity and excessive heat, above 40ºC (104ºF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

D&C red # 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topcare
NDC 36800-122-73
COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*
EXTRA STRENGTH
Gas
Relief
ANTI-GAS/SIMETHICONE, 125 mg

FAST RELIEF OF:

Bloating
Pressure
Discomfort of Gas

CHERRY FLAVOR

18 CHEWABLE TABLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
314221	simethicone 125 MG Chewable Tablet	PSN	2
314221	simethicone 125 MG Chewable Tablet	SCD	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-122-73	Gas Relief	3 in 1 CARTON	TABLET, CHEWABLE	3		2
36800-122-73	Gas Relief	6 in 1 BLISTER PACK	TABLET, CHEWABLE	6		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-122	GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [TOPCO ASSOCIATES, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20241228_c90d68a0-22e1-4a37-8487-16ecdc431ede.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Gas Relief
Simethicone
DIMETHICONE
D&C RED NO. 30
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SORBITOL
SUCROSE
MALTODEXTRIN
DEXTROSE, UNSPECIFIED FORM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-122	36800-122-73

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
D&C RED NO. 30	2S42T2808B	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SORBITOL	506T60A25R	IACT
SUCROSE	C151H8M554	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gas Relief	SIMETHICONE	Topco Associates, LLC	c90d68a0-22e1-4a37-8487-16ecdc431ede	2024-12-26	Warnings	Exact identifier ndc (package): 36800-122-73 ndc (product): 36800-122 ndc11 (package): 36800012273 spl id: 060e2eb9-d8f8-448f-8db4-928ebac288a9 spl set id: c90d68a0-22e1-4a37-8487-16ecdc431ede

Reported adverse events (FAERS/openFDA)#

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