Gas Relief

Manufacturer
We Care Distributor Inc. | SOFTGEL HEALTHCARE PVT LTD
Effective date
2016-03-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:45:30

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

for relief of ■ pressure, bloating, and fullness commonly referred to as gas

Dosage and administration

■ adults: 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 moisture ■ read all product information before using. ■ keep this box for important information

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each softgel)                                         Purpose

Simethicone 180 mg............................................................. Antigas

Uses

INDICATIONS & USAGE SECTION

for relief of

■ pressure, bloating, and fullness commonly referred to as gas

Warnings

WARNINGS SECTION

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ adults: 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 moisture

■ read all product information before using.

■ keep this box for important information

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow 6, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitol, titanium dioxide

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients in
Gas-X Ultra Strength

Simethicone Softgels, 80 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Softgel Each

Principal Display Panel - 50 Pouch BoxPrincipal Display Panel - 50 Pouch Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252294simethicone 180 MG Oral CapsulePSN4
252294simethicone 180 MG Oral CapsuleSCD4
252294dimethicone 180 MG Oral CapsuleSY4

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70005-019-02Gas Relief2 in 1 POUCHCAPSULE, LIQUID FILLED24
70005-019-25Gas Relief25 in 1 BOXCAPSULE, LIQUID FILLED254
70005-019-25Gas Relief2 in 1 POUCHCAPSULE, LIQUID FILLED24
70005-019-50Gas Relief50 in 1 BOXCAPSULE, LIQUID FILLED504
70005-019-50Gas Relief2 in 1 POUCHCAPSULE, LIQUID FILLED24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70005-019GAS RELIEF (SIMETHICONE 180 MG) CAPSULE, LIQUID FILLED [WE CARE DISTRIBUTOR INC.]4Legacy NDC, 5 package rows20160323_90178439-c3fe-47d1-bebb-466371fa2adf.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70005-01970005-019-25, 70005-019-50, 70005-019-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
7bd332d3-ce1c-43a8-b913-b7f97850151590178439-c3fe-47d1-bebb-466371fa2adf2016-03-22WarningsExact identifier
spl id: 7bd332d3-ce1c-43a8-b913-b7f978501515
spl set id: 90178439-c3fe-47d1-bebb-466371fa2adf

Reported adverse events (FAERS/openFDA)#

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