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Paxil CR

Generic Name: paroxetine hydrochloride
Dosage Form: tablet, film coated, extended release

Medically reviewed on December 1, 2017

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 LABEL Item Code (Source) NDC:53873-045
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (PAROXETINE) PAROXETINE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED  
POVIDONE K30  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
GLYCERYL DIBEHENATE  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
SODIUM LAURYL SULFATE  
POLYSORBATE 80  
TALC  
TRIETHYL CITRATE  
TITANIUM DIOXIDE  
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code GSK;12;5
Contains     
Packaging
# Item Code Package Description
1 NDC:53873-045-00 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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 LABEL Item Code (Source) NDC:53873-046
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (PAROXETINE) PAROXETINE 25 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED  
POVIDONE K30  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
GLYCERYL DIBEHENATE  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
SODIUM LAURYL SULFATE  
POLYSORBATE 80  
TALC  
TRIETHYL CITRATE  
TITANIUM DIOXIDE  
Product Characteristics
Color PINK Score no score
Shape ROUND Size 7mm
Flavor Imprint Code GSK;25
Contains     
Packaging
# Item Code Package Description
1 NDC:53873-046-00 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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 LABEL Item Code (Source) NDC:53873-047
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (PAROXETINE) PAROXETINE 37.5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED  
POVIDONE K30  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
GLYCERYL DIBEHENATE  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
SODIUM LAURYL SULFATE  
POLYSORBATE 80  
TALC  
TRIETHYL CITRATE  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code GSK;37;5
Contains     
Packaging
# Item Code Package Description
1 NDC:53873-047-00 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA020936 01/01/2011
Labeler - GlaxoSmithKline Inc (205556368)
 
GlaxoSmithKline Inc
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