FDA.reportPublic FDA data

Maximum Strength Gas Relief Softgel

Manufacturer
CVS PHARMACY, INC
Effective date
2024-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:51:00

Label at a glance#

ProductMaximum Strength Gas Relief Softgel
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure10 sections

Indications and uses

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

Dosage and administration

• Swallow one or two softgels as symptoms occur • do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician

Storage and handling

• store at room temperature 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

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

Warnings

WARNINGS SECTION

Stop use and ask a doctor if condition persists.

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

• Swallow one or two softgels as symptoms occur
• 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 20-25°C (68-77°F)
• protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #33, edible ink, FD&C blue #1, gelatin, glycerin, purified water

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*

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

Compare to the active ingredient in PHAZYME® Maximum Strength*

Fast relief of:
• Bloating
• Pressure
• Fullness

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

TAMPER EVIDENT: DO NOT USE IF THE IMPRINTED SAFETY SEAL UNDER CAP IS TORN OR MISSING.

*This product is not manufactured or distributed by C.B. Fleet Company, Inc., distributor of PHAZYME®.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2022 CVS/pharmacy  CVS.com®
1-800-SHOP CVS
Product of United Arab Emirates.
V-39102

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS-813CVS-813

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
51316-813-06Maximum Strength Gas Relief Softgel60 in 1 BOTTLECAPSULE, LIQUID FILLED604
51316-813-06Maximum Strength Gas Relief Softgel1 in 1 CARTONCAPSULE, LIQUID FILLED14
51316-813-36Maximum Strength Gas Relief Softgel18 in 1 BLISTER PACKCAPSULE, LIQUID FILLED184
51316-813-36Maximum Strength Gas Relief Softgel2 in 1 CARTONCAPSULE, LIQUID FILLED24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-813MAXIMUM STRENGTH GAS RELIEF SOFTGEL (SIMETHICONE) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC]4Current NDC, Legacy NDC, 4 package rows20250108_de059bd9-40de-432d-9370-5d1e53bd89ac.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-81351316-813-36, 51316-813-06

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
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
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
Maximum Strength Gas Relief SoftgelSIMETHICONECVS PHARMACY, INCde059bd9-40de-432d-9370-5d1e53bd89ac2024-12-30WarningsExact identifier
ndc (package): 51316-813-36
ndc (package): 51316-813-06
ndc (product): 51316-813
ndc11 (package): 51316081306
ndc11 (package): 51316081336
spl id: 5833b163-4cc3-40e0-bfa3-30734f26ff08
spl set id: de059bd9-40de-432d-9370-5d1e53bd89ac

Reported adverse events (FAERS/openFDA)#

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