Gas Relief

Manufacturer
PuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date
2016-07-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:33

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

relieves bloating, pressure or fullness commonly referred to as gas

Dosage and administration

swallow one or two softgels as needed after a meal do not exceed two softgels per day except under the advice and supervision of a physician.

Storage and handling

store at room temperature 59º - 86ºF (15º - 30ºC)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 180 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

OTC - STOP USE SECTION

Stop use and ask a doctorif condition persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow one or two softgels as needed after a meal
  • do not exceed two softgels per day except under the advice and supervision of a physician.

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 59º - 86ºF (15º - 30ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow#6, gelatin, glycerin, purified water and white edible ink

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ULTRA STRENGTH Gas Relief

Simethicone 180 mg Antigas

NDC 51013-115-01

*Compare to the active ingredient in PHAZYME® Ultra Strength

PV Ultra Gas Relief 16ctPV Ultra Gas Relief 16ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252294simethicone 180 MG Oral CapsulePSN1
252294simethicone 180 MG Oral CapsuleSCD1
252294dimethicone 180 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
51013-115-012025-01-30C16284748780-12cef2736-a838-d83d-e063-dadaa90ab31fGas Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-115-01Gas Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED101
51013-115-01Gas Relief1 in 1 CARTONCAPSULE, LIQUID FILLED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-115GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]1Legacy NDC, 2 package rows20160715_b2660ac7-a050-459f-a4a0-108e3f994720.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51013-11551013-115-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
7b6027bd-a8f8-4872-8dff-2695745f819bb2660ac7-a050-459f-a4a0-108e3f9947202016-07-15WarningsExact identifier
spl id: 7b6027bd-a8f8-4872-8dff-2695745f819b
spl set id: b2660ac7-a050-459f-a4a0-108e3f994720

Reported adverse events (FAERS/openFDA)#

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