PAXIL (Page 18 of 18)

Principal Display Panel

NDC 0029-3210-13

PAXIL®

PAROXETINE HCl TABLETS

10 mg

30 Tablets Scored Tablets

Rx only

Federal Law requires dispensing of Paxil® with the Medication Guide under this label.

Store tablets between 15o and 30o C (59o and 86o F). Dispense in a tight, light-resistant container. Each tablet contains paroxetine hydrochloride equivalent to 10 mg paroxetine.

Dosage: See accompanying prescribing information.

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

GlaxoSmithKline

RTP, NC 27709

Made in Ireland

A059793 Rev. 9/08

10-mg, 30-tablet bottle label
(click image for full-size original)

Principal Display Panel

NDC 0029-3211-13

PAXIL®

PAROXETINE HCl TABLETS

20 mg

30 Tablets

Rx only

Federal Law requires dispensing of Paxil® with the Medication Guide under this label.

Store tablets between 15o and 30o C (59o and 86o F). Dispense in a tight, light-resistant container. Each tablet contains paroxetine hydrochloride equivalent to 20 mg paroxetine.

Dosage: See accompanying prescribing information.

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

GlaxoSmithKline

RTP, NC 27709

Made in Ireland

A059792 Rev. 9/08

20-mg, 30-tablet bottle label
(click image for full-size original)

Principal Display Panel

NDC 0029-3212-13

PAXIL®

PAROXETINE HCl TABLETS

30 mg

30 Tablets

Rx only

Federal Law requires dispensing of Paxil® with the Medication Guide under this label.

Store tablets between 15o and 30o C (59o and 86o F). Dispense in a tight, light-resistant container. Each tablet contains paroxetine hydrochloride equivalent to 30 mg paroxetine.

Dosage: See accompanying prescribing information.

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

GlaxoSmithKline

RTP, NC 27709

Made in Ireland

A059791 Rev. 7/08

30-mg, 30-tablet bottle label
(click image for full-size original)

Principal Display Panel

NDC 0029-3213-13

PAXIL®

PAROXETINE HCl TABLETS

40 mg

30 Tablets

Rx only

Federal Law requires dispensing of Paxil® with the Medication Guide under this label.

Store tablets between 15o and 30o C (59o and 86o F). Dispense in a tight, light-resistant container. Each tablet contains paroxetine hydrochloride equivalent to 40 mg paroxetine.

Dosage: See accompanying prescribing information.

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

GlaxoSmithKline

RTP, NC 27709

Made in Ireland

A059411 Rev. 9/08

40-mg, 30-tablet bottle label
(click image for full-size original)

Principal Display Panel

NDC 0029-3215-48

PAXIL®

PAROXETINE HCl

ORAL SUSPENSION

10mg/5mL

250 mL

Rx only

Federal Law requires dispensing of Paxil® Oral Suspension with the Medication Guide under this label.

Store at or below 25o C (77o F).

Keep tightly closed.

Shake well before using.

Each 5 mL contains paroxetine hydrochloride equivalent to 10 mg paroxetine.

Dosage: See accompanying prescribing information.

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland.

A063934

10 mg per 5 mL, 250 mL  oral suspension bottle label
(click image for full-size original)
PAXIL paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0029-3210
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE (PAROXETINE) PAROXETINE 10 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL (modified oval) Size 9mm
Flavor Imprint Code PAXIL;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0029-3210-13 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020031 03/27/1996 02/28/2013
PAXIL paroxetine hydrochloride suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0029-3215
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE (PAROXETINE) PAROXETINE 10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
POLACRILIN POTASSIUM
CELLULOSE, MICROCRYSTALLINE
PROPYLENE GLYCOL
GLYCERIN
SORBITOL
METHYLPARABEN
PROPYLPARABEN
TRISODIUM CITRATE DIHYDRATE
ANHYDROUS CITRIC ACID
SACCHARIN SODIUM
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0029-3215-48 250 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020710 02/06/1998 06/30/2013
PAXIL paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0029-3211
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE (PAROXETINE) PAROXETINE 20 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL (modified oval) Size 11mm
Flavor Imprint Code PAXIL;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0029-3211-13 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0029-3211-59 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020031 01/14/1993 04/30/2013
PAXIL paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0029-3212
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE (PAROXETINE) PAROXETINE 30 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score no score
Shape OVAL (modified oval) Size 13mm
Flavor Imprint Code PAXIL;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0029-3212-13 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020031 01/05/1993 04/30/2013
PAXIL paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0029-3213
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE (PAROXETINE) PAROXETINE 40 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color GREEN Score no score
Shape OVAL (modified oval) Size 14mm
Flavor Imprint Code PAXIL;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0029-3213-13 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020031 03/27/1996 04/30/2013
Labeler — GlaxoSmithKline LLC (167380711)

Revised: 02/2012 GlaxoSmithKline LLC

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