FDA.reportPublic FDA data

Maximum Strength Gas Relief

Manufacturer
Chain Drug Marketing Association, Inc.
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:50:16

Label at a glance#

ProductMaximum Strength Gas Relief
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 #33, edible ink, FD&C blue #1, gelatin, glycerin, peppermint oil, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033

SPL UNCLASSIFIED SECTION

QUALITY CHOICE

*Compare to the active Ingredient in Maximum Strength Phazyme®

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING

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

Product of UAE

Packaged and Qualify Assured in the USA

REV.01-092022

QC 100% SATISFACTION GUARANTEED

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MSGasRelf1MSGasRelf1

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
63868-975-06Maximum Strength Gas Relief1 in 1 CARTONCAPSULE, LIQUID FILLED14
63868-975-06Maximum Strength Gas Relief60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-975MAXIMUM STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION, INC.]4Current NDC, 2 package rows20250101_e8b2c528-121d-519a-e053-2a95a90a4119.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-97563868-975-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
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 ReliefSIMETHICONEChain Drug Marketing Association, Inc.e8b2c528-121d-519a-e053-2a95a90a41192024-12-16WarningsExact identifier
ndc (package): 63868-975-06
ndc (product): 63868-975
ndc11 (package): 63868097506
spl id: 887f0f64-c695-457a-9310-8dfbb55bf792
spl set id: e8b2c528-121d-519a-e053-2a95a90a4119

Reported adverse events (FAERS/openFDA)#

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