PHAZYME ULTIMATE

Manufacturer: C.B. Fleet Company, Inc.
Effective date: 2024-08-14
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 20:56:51

Label at a glance#

ProductPHAZYME ULTIMATE

Active ingredientDIMETHICONE

Label structure9 sections

Dosage and administration

Swallow (1) Fast Gel as symptoms occur Do not exceed (1) Fast Gel per 24 hours except under the advice and supervision of a physician

Contacts and useful links#

PhoneLabel contact1-855-727-4277

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Purpose

OTC - PURPOSE SECTION

Simethicone 500mg……………………………………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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Swallow (1) Fast Gel as symptoms occur
Do not exceed (1) Fast Gel per 24 hours except under the advice and supervision of a physician

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue #1, gelatin, glycerin, water

Questions?

OTC - QUESTIONS SECTION

Call toll-free 1-855-727-4277

TAMPER EVIDENT PACKAGE

Do not use if blister or printed foil is broken or torn, or if “PZ500” is missing from Fast Gel.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHAZYME® ULTIMATE

ANTI-GAS SIMETHICONE 500 mg

10 fast gels

Principal Display Panel PHAZYME® ULTIMATE ANTI-GAS SIMETHICONE 500 mg 10 fast gels

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0132-0217	PHAZYME ULTIMATE (SIMETHICONE) CAPSULE, LIQUID FILLED [C.B. FLEET COMPANY, INC.]	3	Legacy NDC	20240814_1ec2c8d4-e788-427b-9a66-134aa745580a.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

PHAZYME ULTIMATE
SIMETHICONE
DIMETHICONE
FD&C BLUE NO. 1
WATER
GELATIN
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0132-0217	0132-0217-10, 0132-0217-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
FD&C BLUE NO. 1	H3R47K3TBD	IACT
WATER	059QF0KO0R	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	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
8dd25c1b-bc81-4b2d-bb3b-2ed63210179f			1ec2c8d4-e788-427b-9a66-134aa745580a	2024-08-14	Warnings	Exact identifier spl id: 8dd25c1b-bc81-4b2d-bb3b-2ed63210179f spl set id: 1ec2c8d4-e788-427b-9a66-134aa745580a

Reported adverse events (FAERS/openFDA)#

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