FDA.reportPublic FDA data

Gas Relief

Manufacturer
Best Choice (Valu Merchandisers Company)
Effective date
2024-02-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:08:47

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure10 sections

Dosage and administration

swallow one or two softgels as needed after meals do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Storage and handling

store between 15-30ºC (59-86ºF) protect from heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 180 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

  • relieves bloating, pressure, or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow one or two softgels as needed after meals
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

  • store between 15-30ºC (59-86ºF)
  • protect from heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow #6, gelatin, glycerin, water

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Phazyme® Ultra Strength

ULTRA STRENGTH

Gas Relief

SIMETHICONE 180 mg

ANTIGAS

FOR relief of

  • Gas
  • Pressure
  • Bloating
  • Discomfort

SOFTGELS

†This product is not manufactured or distributed by Prestige Consumer Healthcare, Inc., distributor of Phazyme® Ultra Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BEST CHOICE Ultra Strength Gas Relief
BEST CHOICE Ultra Strength Gas Relief

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
63941-152-60Gas Relief60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED603
63941-152-60Gas Relief1 in 1 BOXCAPSULE, LIQUID FILLED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-152GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]3Current NDC, 2 package rows20240221_23eda70b-ff1e-4b4e-9f9e-034ef101cd68.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
63941-15263941-152-60
51013-115

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
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
Gas ReliefSIMETHICONEBest Choice (Valu Merchandisers Company)23eda70b-ff1e-4b4e-9f9e-034ef101cd682024-02-20WarningsExact identifier
ndc (package): 63941-152-60
ndc (product): 63941-152
ndc11 (package): 63941015260
spl id: f031f988-51ab-487b-bc03-c8a5d8a03ddb
spl set id: 23eda70b-ff1e-4b4e-9f9e-034ef101cd68

Reported adverse events (FAERS/openFDA)#

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