Phazyme Ultimate 500 mg _0132-0222

Manufacturer: C.B. Fleet Company, Inc.
Effective date: 2026-05-20
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 01:58:16

Label at a glance#

ProductPhazyme Ultimate

Active ingredientDIMETHICONE

Label structure10 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

Active Ingredient (in each fast gel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 500mg

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.

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 no. 1, gelatin, glycerin, medium-chain triglycerides, silicon dioxide, sorbitol, water

Questions?

OTC - QUESTIONS SECTION

Call toll-free 1-855-727-4277

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHAZYME®
ANTI-GAS SIMETHICONE 500mg

ULTIMATE
500 MG

20 Fast Gels

Principal Display Panel PHAZYME® ANTI-GAS SIMETHICONE 500mg ULTIMATE 500 MG 20 Fast Gels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2478331	Phazyme 500 MG Oral Capsule	PSN	3
2477951	simethicone 500 MG Oral Capsule	PSN	3
2478331	simethicone 500 MG Oral Capsule [Phazyme]	SBD	3
2477951	simethicone 500 MG Oral Capsule	SCD	3
2478331	Phazyme 500 MG Oral Capsule	SY	3

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	SPL version
0132-0222-10	Phazyme Ultimate	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	3
0132-0222-10	Phazyme Ultimate	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	3
0132-0222-20	Phazyme Ultimate	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	3
0132-0222-20	Phazyme Ultimate	2 in 1 BOX	CAPSULE, LIQUID FILLED	2	3

Products#

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

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

Phazyme Ultimate
SIMETHICONE
DIMETHICONE
FD&C BLUE NO. 1
WATER
GELATIN
GLYCERIN
MEDIUM-CHAIN TRIGLYCERIDES
SILICON DIOXIDE
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0132-0222	0132-0222-10, 0132-0222-20

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
DIMETHICONE	92RU3N3Y1O	ACTIB
FD&C BLUE NO. 1	H3R47K3TBD	IACT
WATER	059QF0KO0R	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SORBITOL	506T60A25R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
2	2025-10-23	monthly-update	2026-06-03 17:38:14
1	2024-08-14	full-release	2026-06-01 00:17:08

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
Phazyme Ultimate	SIMETHICONE	C.B. Fleet Company, Inc.	c8e9f6ac-2db2-4d21-a4b1-5ca6c3105662	2026-05-20	Warnings	Exact identifier ndc (package): 0132-0222-20 ndc (package): 0132-0222-10 ndc (product): 0132-0222 ndc11 (package): 00132022220 ndc11 (package): 00132022210 spl id: 7a0be931-8446-4b99-b7a2-d104acfc9af0 spl set id: c8e9f6ac-2db2-4d21-a4b1-5ca6c3105662

Reported adverse events (FAERS/openFDA)#

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