PAXIL CR- paroxetine hydrochloride tablet, film coated, extended release
GlaxoSmithKline Inc

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PAXIL CRManufacturer

Principal Display Panel

NDC 60505-3668-3

PAXIL CR®

PAROXETINE HCl

CONTROLLED-RELEASE TABLETS

12.5 mg

30 Tablets

Rx only

Federal Law requires dispensing of Paxil CR® with the Medication Guide provided with this bottle.

Store at or below 25oC (77oF) [see USP].

Each controlled-release tablet contains paroxetine hydrochloride equivalent to 12.5 mg paroxetine.

Dosage: See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.

Manufactured by:

GlaxoSmithKline

RTP, NC 27709

Distributed by:

Apotex Corp.

Weston, FL 33326

Made in Canada

A108356 Rev. 7/12

Principal Display Panel

NDC 60505-3669-3

PAXIL CR®

PAROXETINE HCl

CONTROLLED-RELEASE TABLETS

25 mg

30 Tablets

Rx only

Federal Law requires dispensing of Paxil CR® with the Medication Guide provided with this bottle.

Store at or below 25oC (77oF) [see USP].

Each controlled-release tablet contains paroxetine hydrochloride equivalent to 25 mg paroxetine.

Dosage: See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.

Manufactured by:

GlaxoSmithKline

RTP, NC 27709

Distributed by:

Apotex Corp.

Weston, FL 33326

Made in Canada

A108017 Rev. 7/12

Principal Display Panel

NDC 60505-3670-3

PAXIL CR®

PAROXETINE HCl

CONTROLLED-RELEASE TABLETS

37.5 mg

30 Tablets

Rx only

Federal Law requires dispensing of Paxil CR® with the Medication Guide provided with this bottle.

Store at or below 25oC (77oF) [see USP].

Each controlled-release tablet contains paroxetine hydrochloride equivalent to 37.5 mg paroxetine.

Dosage: See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.

Manufactured by:

GlaxoSmithKline

RTP, NC 27709

Distributed by:

Apotex Corp.

Weston, FL 33326

Made in Canada

A108019 Rev. 7/12

PAXIL CR
paroxetine hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:53873-045
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (UNII: X2ELS050D8) (PAROXETINE - UNII:41VRH5220H)	PAROXETINE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POVIDONE K30 (UNII: U725QWY32X)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	GSK;12;5
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53873-045-00	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Approved Drug Product Manufactured Under Contract	NDA020936	01/01/2011

PAXIL CR
paroxetine hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:53873-046
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (UNII: X2ELS050D8) (PAROXETINE - UNII:41VRH5220H)	PAROXETINE	25 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POVIDONE K30 (UNII: U725QWY32X)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	GSK;25
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53873-046-00	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Approved Drug Product Manufactured Under Contract	NDA020936	01/01/2011

PAXIL CR
paroxetine hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:53873-047
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (UNII: X2ELS050D8) (PAROXETINE - UNII:41VRH5220H)	PAROXETINE	37.5 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POVIDONE K30 (UNII: U725QWY32X)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	GSK;37;5
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53873-047-00	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Approved Drug Product Manufactured Under Contract	NDA020936	01/01/2011

Labeler - GlaxoSmithKline Inc (205556368)

Revised: 12/2017

Document Id: cd76d1e7-8c7a-4851-bb0e-c590c1c0de8f

Set id: cd76d1e7-8c7a-4851-bb0e-c590c1c0de8f

Version: 1

Effective Time: 20171212

GlaxoSmithKline Inc