Ultra Strength Gas Relief

Manufacturer
Walgreen Co. | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date
2024-11-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:38:46

Label at a glance#

ProductUltra Strength Gas Relief
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

relieves bloating, pressure or fullness commonly referred to as gas

Dosage and administration

swallow 1 or 2 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 doctor ifcondition persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow 1 or 2 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 Anti-gas  60 Softgels

NDC 0363-9942-22

*Compare to the active ingredient in PHAZYME ®Ultra Strength

frontfront

backback

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252294simethicone 180 MG Oral CapsulePSN3
252294simethicone 180 MG Oral CapsuleSCD3
252294dimethicone 180 MG Oral CapsuleSY3

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9942-22Ultra Strength Gas Relief1 in 1 CARTONCAPSULE, LIQUID FILLED13
0363-9942-22Ultra Strength Gas Relief60 in 1 BOTTLECAPSULE, LIQUID FILLED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9942ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [WALGREEN CO.]3Current NDC, Legacy NDC, 2 package rows20241123_d33e413d-4add-459f-ba46-c23b49cfcc87.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
0363-99420363-9942-22

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 · Source PDF

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
Ultra Strength Gas ReliefSIMETHICONEWalgreen Co.d33e413d-4add-459f-ba46-c23b49cfcc872024-11-21WarningsExact identifier
ndc (package): 0363-9942-22
ndc (product): 0363-9942
ndc11 (package): 00363994222
spl id: 2778541e-52c4-d375-e063-6394a90ac7e4
spl set id: d33e413d-4add-459f-ba46-c23b49cfcc87

Reported adverse events (FAERS/openFDA)#

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