Gas Relief

Manufacturer
PuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date
2016-07-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:37

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

for the 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 4 softgels in 24 hours except under the advice and supervision of a physician

Storage and handling

store at room temperature 15°-30°C (59°-86°F) protect from light, 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: 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 room temperature 15°-30°C (59°-86°F)
  • protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

Call: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH GAS RELIEF 

 ANTIGAS SIMETHICONE 125 mg  30 SOFTGELS

NDC 51013-132-10

*Compare to the active ingredient in Gas-X® Extra Strength Softgels

MB ES Gas Relief 30ctMB ES Gas Relief 30ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198852simethicone 125 MG Oral CapsulePSN1
198852simethicone 125 MG Oral CapsuleSCD1
198852dimethicone 125 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51013-132-102025-01-30C16284748780-12cef2736-7dd8-d83d-e063-dadaa90ab31fEXTRA STRENGTH GAS RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-132-10Gas Relief3 in 1 CARTONCAPSULE, LIQUID FILLED31
51013-132-10Gas Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-132GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]1Legacy NDC, 2 package rows20160726_ce148c8a-ad2b-48b5-bb96-8bb691a48c74.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51013-13251013-132-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
db03b7a1-354b-4ee0-aafa-e0149c1903dcce148c8a-ad2b-48b5-bb96-8bb691a48c742016-07-26WarningsExact identifier
spl id: db03b7a1-354b-4ee0-aafa-e0149c1903dc
spl set id: ce148c8a-ad2b-48b5-bb96-8bb691a48c74

Reported adverse events (FAERS/openFDA)#

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