QUALITY CHOICE Maximum Strength Gas Relief Softgel

Manufacturer
Chain Drug Marketing Association, Inc.
Effective date
2024-08-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:17:51

Label at a glance#

ProductQUALITY CHOICE Maximum 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 heat, humidity and light

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 heat, humidity and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red no.33, edible ink, FD&C blue no.1, gelatin, glycerin, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 

SPL UNCLASSIFIED SECTION

Compare to the Active Ingredient in Maximum Strength Phazyme®

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 

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

PRODUCT OF UNITED ARAB EMIRATES

QC 100% SATISFACTION GUARANTEED

Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gas Relief softgelsGas Relief softgels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
412111simethicone 250 MG Oral CapsulePSN1
412111simethicone 250 MG Oral CapsuleSCD1
412111dimethicone 250 MG Oral CapsuleSY1

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
83324-304-60QUALITY CHOICE Maximum Strength Gas Relief Softgel1 in 1 CARTONCAPSULE, LIQUID FILLED11
83324-304-60QUALITY CHOICE Maximum Strength Gas Relief Softgel60 in 1 BOTTLECAPSULE, LIQUID FILLED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-304QUALITY CHOICE MAXIMUM STRENGTH GAS RELIEF SOFTGEL (SIMETHICONE) CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION, INC.]1Current NDC, 2 package rows20240828_462fdb9a-d685-4772-9233-6c43db9382cc.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
83324-30483324-304-60

Ingredients#

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

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

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
QUALITY CHOICE Maximum Strength Gas Relief SoftgelSIMETHICONEChain Drug Marketing Association, Inc.462fdb9a-d685-4772-9233-6c43db9382cc2024-08-16WarningsExact identifier
ndc (package): 83324-304-60
ndc (product): 83324-304
ndc11 (package): 83324030460
spl id: 80a393f0-2567-493f-945b-2a0866546b61
spl set id: 462fdb9a-d685-4772-9233-6c43db9382cc

Reported adverse events (FAERS/openFDA)#

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