FDA.reportPublic FDA data

Gas Relief

Manufacturer
PURACAP PHARMACEUTICAL LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date
2018-03-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:01

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 toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH GAS RELIEF 

SIMETHICONE 125 mg ANTI-GAS 20 Softgels

NDC 51013-430-08

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

frontfront

backback

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
51013-430-072025-01-30C16284748780-12cef2736-b509-d83d-e063-dadaa90ab31fExtra Strength Gas Relief
51013-430-082025-01-30C16284748780-12cef2736-b509-d83d-e063-dadaa90ab31fExtra Strength Gas Relief
51013-430-092025-01-30C16284748780-12cef2736-b509-d83d-e063-dadaa90ab31fExtra Strength Gas Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-430-07Gas Relief18 in 1 BLISTER PACKCAPSULE, LIQUID FILLED181
51013-430-07Gas Relief4 in 1 CARTONCAPSULE, LIQUID FILLED41
51013-430-08Gas Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED101
51013-430-08Gas Relief2 in 1 CARTONCAPSULE, LIQUID FILLED21
51013-430-09Gas Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED101
51013-430-09Gas Relief5 in 1 CARTONCAPSULE, LIQUID FILLED51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-430GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]1Legacy NDC, 6 package rows20180328_45f5a76a-cd7c-4152-96b5-272286ad2502.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
51013-43051013-430-08, 51013-430-09, 51013-430-07

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
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT

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
51dd27fd-405d-4ca7-a14a-ed7cdae8da5945f5a76a-cd7c-4152-96b5-272286ad25022018-03-27WarningsExact identifier
spl id: 51dd27fd-405d-4ca7-a14a-ed7cdae8da59
spl set id: 45f5a76a-cd7c-4152-96b5-272286ad2502

Reported adverse events (FAERS/openFDA)#

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