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Drug Facts

Manufacturer
CVS PHARMACY, INC
Effective date
2026-05-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:58:26

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

For the relief of pressure, bloating, and fullness commonly referred to as gas.

Dosage and administration

adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Storage and handling

store between 20-25°C (68-77°F) do not refrigerate  protect from light, heat, and moisture

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

For the relief of pressure, bloating, and fullness commonly referred to as gas.

Warnings

WARNINGS SECTION

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

  • adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)
  • do not refrigerate 
  • protect from light, heat, and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin (bovine), glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

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 Gas-X® Extra Strength active ingredient*

Extra Strength

GAS RELIEF

Simethicone 125 mg

Anti-gas

Fast Relief of: Pressure, Bloating, Discomfort

SOFTGELS

*This product is not manufactured or distributed by Haleon group of companies, distributor of Gas-X® Extra Strength.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Extra Strength Gas Relief
CVS Extra Strength Gas Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198852simethicone 125 MG Oral CapsulePSN9
198852simethicone 125 MG Oral CapsuleSCD9
198852dimethicone 125 MG Oral CapsuleSY9

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-597-12Gas Relief120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1209
51316-597-12Gas Relief1 in 1 BOXCAPSULE, LIQUID FILLED19
51316-597-20Gas Relief1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED19
51316-597-20Gas Relief72 in 1 CARTONCAPSULE, LIQUID FILLED729
51316-597-30Gas Relief1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED19
51316-597-30Gas Relief30 in 1 CARTONCAPSULE, LIQUID FILLED309

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-59751316-597-12, 51316-597-20, 51316-597-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MANNITOL3OWL53L36AIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-12-17monthly-update2026-06-03 17:46:16
72025-11-19monthly-update2026-06-03 17:40:21
52025-09-03full-release2026-06-01 01:12:28

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 ReliefSIMETHICONECVS PHARMACY, INC4ff77b4c-9616-4341-9bf8-eca301345a5f2026-05-21WarningsExact identifier
ndc (package): 51316-597-12
ndc (package): 51316-597-20
ndc (package): 51316-597-30
ndc (product): 51316-597
ndc11 (package): 51316059720
ndc11 (package): 51316059730
ndc11 (package): 51316059712
spl id: 37e6d1e0-23cb-4f69-acdf-bfa8b157d16c
spl set id: 4ff77b4c-9616-4341-9bf8-eca301345a5f

Reported adverse events (FAERS/openFDA)#

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