Maximum Strength Gas Relief

Manufacturer: Spirit Pharmaceuticals LLC
Effective date: 2024-12-13
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:43:18

Label at a glance#

ProductMaximum Strength Gas Relief

Active ingredientDIMETHICONE

Label structure9 sections

Dosage and administration

swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Storage and handling

store at room temperature 59°-86°F (15°-30°C)

Contacts and useful links#

PhoneLabel contact1-888-333-9792

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Use

INDICATIONS & USAGE SECTION

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

swallow one or two softgels after a meal
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

store at room temperature 59°-86°F (15°-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol sorbitan, titanium dioxide

Questions or Comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUMEDS MAXIMUM STRENGTH GAS RELIEF

SIMETHICONE 250 mg/ Anti-gas

Compare to the active ingredient in PHAZYME® Maximum Strength*

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

70 SOFTGELS

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
412111	simethicone 250 MG Oral Capsule	PSN	5
412111	simethicone 250 MG Oral Capsule	SCD	5
412111	dimethicone 250 MG Oral Capsule	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68210-4165-7	Maximum Strength Gas Relief	70 in 1 BOTTLE	CAPSULE, GELATIN COATED	70		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-4165	MAXIMUM STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, GELATIN COATED [SPIRIT PHARMACEUTICALS LLC]	5	Legacy NDC, 1 package rows	20241215_748638dd-62dc-4e69-a79e-3d4b369ea888.zip

Products#

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

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

Maximum Strength Gas Relief
Simethicone
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POVIDONE
SORBITOL SOLUTION
WATER
DIMETHICONE
D&C RED NO. 33

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68210-4165	68210-4165-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POVIDONE	FZ989GH94E	IACT
SORBITOL SOLUTION	8KW3E207O2	IACT
WATER	059QF0KO0R	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB
D&C RED NO. 33	9DBA0SBB0L	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
292da91b-c930-c2fc-e063-6394a90ac072			748638dd-62dc-4e69-a79e-3d4b369ea888	2024-12-13	Warnings	Exact identifier spl id: 292da91b-c930-c2fc-e063-6394a90ac072 spl set id: 748638dd-62dc-4e69-a79e-3d4b369ea888

Reported adverse events (FAERS/openFDA)#

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