FDA.reportPublic FDA data

Gas Relief

Manufacturer
Allegiant Health
Effective date
2021-09-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:41:02

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure9 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.

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 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

  • store at room temperature (59°– 86°F) 15°– 30°C
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #33, FD&C blue #1, 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
412111simethicone 250 MG Oral CapsulePSN4
412111simethicone 250 MG Oral CapsuleSCD4
412111dimethicone 250 MG Oral CapsuleSY4

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
69168-434-01Gas Relief100 in 1 BOTTLECAPSULE, LIQUID FILLED1004
69168-434-50Gas Relief50 in 1 BOTTLECAPSULE, LIQUID FILLED504
69168-434-98Gas Relief200 in 1 BOTTLECAPSULE, LIQUID FILLED2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-434GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]4Current NDC, Legacy NDC, 3 package rows20241208_ae98861e-6a26-4e0e-a66a-b2738d3cbddd.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-43469168-434-01, 69168-434-98, 69168-434-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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 Healthae98861e-6a26-4e0e-a66a-b2738d3cbddd2021-09-24WarningsExact identifier
ndc (package): 69168-434-01
ndc (package): 69168-434-50
ndc (package): 69168-434-98
ndc (product): 69168-434
ndc11 (package): 69168043401
ndc11 (package): 69168043498
ndc11 (package): 69168043450
spl id: a9d3ed08-a696-47d9-9e2f-d578cec2ff7d
spl set id: ae98861e-6a26-4e0e-a66a-b2738d3cbddd

Reported adverse events (FAERS/openFDA)#

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