FDA.reportPublic FDA data

CVS Health Gas Relief SOFTGEL

Manufacturer
CVS Pharmacy, Inc
Effective date
2025-08-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:13:23

Label at a glance#

ProductCVS Health Gas Relief SOFTGEL
Active ingredientDIMETHICONE, UNSPECIFIED
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 2 softgels per 24 hours except under the advice and supervision of a physician

Storage and handling

• store at room temperature between 20-25°C (68-77°F) • protect from light, heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

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, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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 2 softgels per 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

• store at room temperature between 20-25°C (68-77°F)
• protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 33, edible ink, FD&C Blue No. 1, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, purified water, soy lecithin

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday-Friday 8am-4pm EST

SPL UNCLASSIFIED SECTION

Compare to the active ingredient in Gas-X® Maximum Strength Softgels*

Fast relief of:
• Bloating
• Pressure
• Fullness

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION.

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com®
1-800-SHOP CVS

Product of United Arab Emirates
V-39102

100% money back guaranteed.
CVS.com/returnpolicy

*This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Gas-X® Maximum Strength Softgels.

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS H Gas Relief SOFTGELCVS H Gas Relief SOFTGEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
412111simethicone 250 MG Oral CapsulePSN3
412111simethicone 250 MG Oral CapsuleSCD3
412111dimethicone 250 MG Oral CapsuleSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-311-05CVS Health Gas Relief SOFTGEL25 in 1 BLISTER PACKCAPSULE, LIQUID FILLED253
51316-311-05CVS Health Gas Relief SOFTGEL2 in 1 CARTONCAPSULE, LIQUID FILLED23
51316-311-30CVS Health Gas Relief SOFTGEL2 in 1 CARTONCAPSULE, LIQUID FILLED23
51316-311-30CVS Health Gas Relief SOFTGEL15 in 1 BLISTER PACKCAPSULE, LIQUID FILLED153

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-31151316-311-30, 51316-311-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
LIGHT MINERAL OILN6K5787QVPIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WATER059QF0KO0RIACT
SOYBEAN LECITHIN1DI56QDM62IACT

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
CVS Health Gas Relief SOFTGELSIMETHICONECVS Pharmacy, Inc2911cac8-45ec-1294-e063-6294a90a4a742025-08-22WarningsExact identifier
ndc (package): 51316-311-30
ndc (package): 51316-311-05
ndc (product): 51316-311
ndc11 (package): 51316031105
ndc11 (package): 51316031130
spl id: d49a110f-0766-4312-9827-0e2106c5d5f5
spl set id: 2911cac8-45ec-1294-e063-6294a90a4a74

Reported adverse events (FAERS/openFDA)#

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