FDA.reportPublic FDA data

Gas Relief

Manufacturer
Allegiant Health
Effective date
2021-09-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:40:52

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure10 sections

Dosage and administration

Swallow 1 or 2 softgels as symptoms occur Do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician.

Storage and handling

store at room temperature (59°– 86°F) 15°– 30°C

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 180 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Use(s)

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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • Swallow 1 or 2 softgels as symptoms
    occur
  • Do not exceed 2 softgels in 24 hours
    except under the advice and
    supervision of a physician.

Other information

SPL UNCLASSIFIED SECTION

Do not use if imprinted safety seal under cap is broken or missing

Storage

STORAGE AND HANDLING SECTION

  • store at room temperature (59°– 86°F) 15°– 30°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gas Relief
Gas Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252294simethicone 180 MG Oral CapsulePSN5
252294simethicone 180 MG Oral CapsuleSCD5
252294dimethicone 180 MG Oral CapsuleSY5

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
69168-433-06Gas Relief120 in 1 BOTTLECAPSULE, LIQUID FILLED1205
69168-433-17Gas Relief300 in 1 BOTTLECAPSULE, LIQUID FILLED3005
69168-433-60Gas Relief60 in 1 BOTTLECAPSULE, LIQUID FILLED605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-433GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]5Current NDC, Legacy NDC, 3 package rows20241208_4c79535c-4372-4fd4-a91a-d93617cd581b.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
69168-43369168-433-06, 69168-433-17, 69168-433-60

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
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
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 ReliefSIMETHICONEAllegiant Health4c79535c-4372-4fd4-a91a-d93617cd581b2021-09-24WarningsExact identifier
ndc (package): 69168-433-17
ndc (package): 69168-433-60
ndc (package): 69168-433-06
ndc (product): 69168-433
ndc11 (package): 69168043317
ndc11 (package): 69168043306
ndc11 (package): 69168043360
spl id: b75ef1f0-789a-416a-a37f-0c93516a5310
spl set id: 4c79535c-4372-4fd4-a91a-d93617cd581b

Reported adverse events (FAERS/openFDA)#

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