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NDC 00132-0208-48 PHAZYME 180 mg/1 Details

PHAZYME 180 mg/1

PHAZYME is a ORAL CAPSULE, GELATIN COATED in the HUMAN OTC DRUG category. It is labeled and distributed by C.B. Fleet Company, Inc.. The primary component is DIMETHICONE.

MedlinePlus Drug Summary

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 00132-0208-48
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	00132-0208
Product ID	0132-0208_fa4012b5-0ff1-4521-b066-0cac49f1486f
Associated GPIs
GCN Sequence Number	040944
GCN Sequence Number Description	simethicone CAPSULE 180 MG ORAL
HIC3	D4N
HIC3 Description	ANTIFLATULENTS
GCN	94652
HICL Sequence Number	001224
HICL Sequence Number Description	SIMETHICONE
Brand/Generic	Brand
Proprietary Name	PHAZYME
Proprietary Name Suffix	n/a
Non-Proprietary Name	Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, GELATIN COATED
Route	ORAL
Active Ingredient Strength	180
Active Ingredient Units	mg/1
Substance Name	DIMETHICONE
Labeler Name	C.B. Fleet Company, Inc.
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part332
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00132-0208-48 (00132020848)

Pricing Information	N/A
NDC Package Code	0132-0208-48
Billing NDC	00132020848
Package	1 BLISTER PACK in 1 BOX (0132-0208-48) / 48 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Marketing Start Date	2012-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3bb5cc1f-554b-4a4d-b9e9-665e34924b4b Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each fast gel)

Simethicone 180mg

Purpose

Anti-gas

Use

Relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

condition persists.

Keep out of reach of children.

Directions

Swallow one or two fast gels as symptoms occur
Do not exceed two fast gels per 24 hours except under the advice and supervision of a physician

Other information

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

Inactive Ingredients

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, purified water

Questions?

Call toll-free 1-855-727-4277

TAMPER EVIDENT PACKAGE

Do not use if blister or printed foil is broken or torn, or if “PZ180” is missing from Fast Gel.

Principal Display Panel

PHAZYME® ULTRA STRENGTH

ANTI-GAS SIMETHICONE 180 MG

12 fast gels

INGREDIENTS AND APPEARANCE

PHAZYME

simethicone capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0132-0208
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	180 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	PZ;180
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0132-0208-12	1 in 1 BOX	02/01/2012
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0132-0208-48	1 in 1 BOX	02/01/2012
2		48 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part332	02/01/2012

Labeler - C.B. Fleet Company, Inc. (003119054)

Revised: 12/2020

Document Id: fa4012b5-0ff1-4521-b066-0cac49f1486f

Set id: 3bb5cc1f-554b-4a4d-b9e9-665e34924b4b

Version: 9

Effective Time: 20201217