NDC Code(s) : 0363-0209-01, 0363-0209-07, 0363-0208-01, 0363-0208-07, 0363-9200-02, 0363-9200-03, 0363-0446-02, 0363-0446-03, 0363-9171-02, 0363-9170-02
Packager : Walgreens

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NICOTINE nicotine polacrilex LOZENGE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0363-0209
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE(UNII: 6M3C89ZY6R)
(NICOTINE - UNII:6M3C89ZY6R) 		NICOTINE4 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN(UNII: RCZ785HI7S)
ASPARTAME(UNII: Z0H242BBR1)
CALCIUM POLYCARBOPHIL(UNII: 8F049NKY49)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POTASSIUM BICARBONATE(UNII: HM5Z15LEBN)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
SODIUM CARBONATE(UNII: 45P3261C7T)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 16 mm
Flavor MINT Imprint Code PL4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0363-0209-016 in 1 CARTON 31/10/2002
112 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:0363-0209-079 in 1 CARTON 31/10/2002
212 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021330 10/31/2002
NICOTINE nicotine polacrilex LOZENGE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0363-0208
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE(UNII: 6M3C89ZY6R)
(NICOTINE - UNII:6M3C89ZY6R) 		NICOTINE2 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN(UNII: RCZ785HI7S)
ASPARTAME(UNII: Z0H242BBR1)
CALCIUM POLYCARBOPHIL(UNII: 8F049NKY49)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POTASSIUM BICARBONATE(UNII: HM5Z15LEBN)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
SODIUM CARBONATE(UNII: 45P3261C7T)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 16 mm
Flavor MINT Imprint Code PL2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0363-0208-016 in 1 CARTON 31/10/2002
112 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:0363-0208-079 in 1 CARTON 31/10/2002
212 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021330 10/31/2002
NICOTINEnicotine polacrilex LOZENGE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0363-9200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE(UNII: 6M3C89ZY6R)
(NICOTINE - UNII:6M3C89ZY6R) 		NICOTINE4 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN(UNII: RCZ785HI7S)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
BENZYL ALCOHOL(UNII: LKG8494WBH)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CALCIUM POLYCARBOPHIL(UNII: 8F049NKY49)
COCONUT OIL(UNII: Q9L0O73W7L)
PALM KERNEL OIL(UNII: B0S90M0233)
EUGENOL(UNII: 3T8H1794QW)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
MANNITOL(UNII: 3OWL53L36A)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(UNII: 461P5CJN6T)
POTASSIUM BICARBONATE(UNII: HM5Z15LEBN)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
SODIUM CARBONATE(UNII: 45P3261C7T)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 16 mm
Flavor CHERRY Imprint Code PL4C
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0363-9200-023 in 1 CARTON 14/07/2011
124 in 1 CONTAINER Type 0: Not a Combination Product
2NDC:0363-9200-034 in 1 CARTON 14/07/2011
227 in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021330 07/14/2011
NICOTINEnicotine polacrilex LOZENGE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0363-0446
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE(UNII: 6M3C89ZY6R)
(NICOTINE - UNII:6M3C89ZY6R) 		NICOTINE2 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN(UNII: RCZ785HI7S)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
BENZYL ALCOHOL(UNII: LKG8494WBH)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CALCIUM POLYCARBOPHIL(UNII: 8F049NKY49)
COCONUT OIL(UNII: Q9L0O73W7L)
PALM KERNEL OIL(UNII: B0S90M0233)
EUGENOL(UNII: 3T8H1794QW)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
MANNITOL(UNII: 3OWL53L36A)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(UNII: 461P5CJN6T)
POTASSIUM BICARBONATE(UNII: HM5Z15LEBN)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
SODIUM CARBONATE(UNII: 45P3261C7T)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 16 mm
Flavor CHERRY Imprint Code PL2C
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0363-0446-023 in 1 CARTON 14/07/2011
124 in 1 CONTAINER Type 0: Not a Combination Product
2NDC:0363-0446-034 in 1 CARTON 14/07/2011
227 in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021330 07/14/2011
NICOTINEnicotine polacrilex LOZENGE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0363-9171
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE(UNII: 6M3C89ZY6R)
(NICOTINE - UNII:6M3C89ZY6R) 		NICOTINE4 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN(UNII: RCZ785HI7S)
ACACIA(UNII: 5C5403N26O)
ASPARTAME(UNII: Z0H242BBR1)
CALCIUM POLYCARBOPHIL(UNII: 8F049NKY49)
CORN SYRUP(UNII: 9G5L16BK6N)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
MANNITOL(UNII: 3OWL53L36A)
POTASSIUM BICARBONATE(UNII: HM5Z15LEBN)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
SODIUM CARBONATE(UNII: 45P3261C7T)
SOY PROTEIN(UNII: R44IWB3RN5)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 16 mm
Flavor MINT Imprint Code PL4S
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0363-9171-023 in 1 CARTON 14/07/2011
124 in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021330 07/14/2011
NICOTINEnicotine polacrilex LOZENGE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0363-9170
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE(UNII: 6M3C89ZY6R)
(NICOTINE - UNII:6M3C89ZY6R) 		NICOTINE2 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN(UNII: RCZ785HI7S)
ACACIA(UNII: 5C5403N26O)
ASPARTAME(UNII: Z0H242BBR1)
CALCIUM POLYCARBOPHIL(UNII: 8F049NKY49)
CORN SYRUP(UNII: 9G5L16BK6N)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
MANNITOL(UNII: 3OWL53L36A)
POTASSIUM BICARBONATE(UNII: HM5Z15LEBN)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
SODIUM CARBONATE(UNII: 45P3261C7T)
SOY PROTEIN(UNII: R44IWB3RN5)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 16 mm
Flavor MINT Imprint Code PL2S
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0363-9170-023 in 1 CARTON 14/07/2011
124 in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021330 07/14/2011

PRINCIPAL DISPLAY PANEL

NDC 0363-0209-01

Nicotine Lozenge

Walgreens

Nicotine Polacrilex Lozenge, 4mg

STOP SMOKING AID

Original Flavor

72 LOZENGES

4mg EACH

Compare to Nicorette®* Lozenge

Includes User’s Guide

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicotine Polacrilex Lozenge, 2mg

  • • not for sale to those under 18 years of age
  • • proof of age required
  • • not for sale in vending machines or from any source where proof of age cannot be verified

This product is protected in sealed blisters.

Do not use if individual blisters or printed backings are broken, open or torn.

TO INCREASE YOUR SUCCESS IN QUITTING:

  • •You must be motivated to quit.
  • • Use Enough – Use at least 9 lozenges per day during the first six weeks.
  • • Use Long Enough – Use for the full 12 weeks.
  • • Use With a Support Program as directed in the enclosed User’s Guide.

To remove the lozenge, tear off single unit.

Peel off backing starting at corner with loose edge.

Push lozenge through foil.

Comments/questions:

GCSP 5.4376.4C Re: Consumer Relations, PO Box 13398

Research Triangle Park, NC 27709-9627

*NICORETTE® is a registered trademark of the GlaxoSmithKline group of companies.

Made in Switzerland

©2011

101025XA

Nicotine Lozenge Walgreens 4mg 72 ct carton

PRINCIPAL DISPLAY PANEL

NDC 0363-0208-01

Nicotine Lozenge

Walgreens

Nicotine Polacrilex Lozenge, 2mg

STOP SMOKING AID

Original Flavor

72 LOZENGES

2mg EACH

Compare to Nicorette®* Lozenge

Includes User’s Guide

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicotine Polacrilex Lozenge, 4mg

  • • not for sale to those under 18 years of age
  • • proof of age required
  • • not for sale in vending machines or from any source where proof of age cannot be verified

This product is protected in sealed blisters.

Do not use if individual blisters or printed backings are broken, open or torn.

TO INCREASE YOUR SUCCESS IN QUITTING:

  • •You must be motivated to quit.
  • • Use Enough – Use at least 9 lozenges per day during the first six weeks.
  • • Use Long Enough – Use for the full 12 weeks.
  • • Use With a Support Program as directed in the enclosed User’s Guide.

To remove the lozenge, tear off single unit.

Peel off backing starting at corner with loose edge.

Push lozenge through foil.

Comments/questions:

GCSP 5.4376.4C Re: Consumer Relations, PO Box 13398

Research Triangle Park, NC 27709-9627

*NICORETTE® is a registered trademark of the GlaxoSmithKline group of companies.

Made in Switzerland

©2011

101032XA

Nicotine Lozenge Walgreens 2mg 72 ct carton

PRINCIPAL DISPLAY PANEL

NDC 0363-9200-02

Nicotine Lozenge

Walgreens

Nicotine Polacrilex Lozenge, 4mg

STOP SMOKING AID

Cherry Flavor

72 LOZENGES, 4mg EACH (3 Vials of 24)

Compare to Nicorette®* Lozenge

Includes User’s Guide

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicotine Polacrilex Lozenge, 2mg

  • • not for sale to those under 18 years of age
  • • proof of age required
  • • not for sale in vending machines or from any source where proof of age cannot be verified

 TAMPER EVIDENT FEATURE: Do not use if clear neckband printed "SEALED FOR SAFETY" is missing or broken.

Retain outer carton for full product uses, directions and warnings.

TO INCREASE YOUR SUCCESS IN QUITTING:

  • •You must be motivated to quit.
  • • Use Enough – Use at least 9 lozenges per day during the first six weeks.
  • • Use Long Enough – Use for the full 12 weeks.
  • • Use With a Support Program as directed in the enclosed User’s Guide.

To open vial, push in child resistant band on the vial with thumb.

Flip up the top of the vial and remove lozenge. A small amount of powder on opening of the vial is normal.

Comments/questions:

GCSP 5.4376.4C Re: Consumer Relations, PO Box 13398

Research Triangle Park, NC 27709-9627

*NICORETTE® is a registered trademark of the GlaxoSmithKline group of companies.

Made in Switzerland

©2011

101157XC

Nicotine Lozenge Walgreens Cherry 4mg 72 ct carton

PRINCIPAL DISPLAY PANEL

NDC 0363-0446-02

Nicotine Lozenge

Walgreens

Nicotine Polacrilex Lozenge, 2mg

STOP SMOKING AID

Cherry Flavor

72 LOZENGES, 2mg EACH (3 Vials of 24)

Compare to Nicorette®* Lozenge

Includes User’s Guide

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicotine Polacrilex Lozenge, 4mg

  • • not for sale to those under 18 years of age
  • • proof of age required
  • • not for sale in vending machines or from any source where proof of age cannot be verified

 TAMPER EVIDENT FEATURE: Do not use if clear neckband printed "SEALED FOR SAFETY" is missing or broken.

Retain outer carton for full product uses, directions and warnings.

TO INCREASE YOUR SUCCESS IN QUITTING:

  • •You must be motivated to quit.
  • • Use Enough – Use at least 9 lozenges per day during the first six weeks.
  • • Use Long Enough – Use for the full 12 weeks.
  • • Use With a Support Program as directed in the enclosed User’s Guide.

To open vial, push in child resistant band on the vial with thumb.

Flip up the top of the vial and remove lozenge. A small amount of powder on opening of the vial is normal.

Comments/questions:

GCSP 5.4376.4C Re: Consumer Relations, PO Box 13398

Research Triangle Park, NC 27709-9627

*NICORETTE® is a registered trademark of the GlaxoSmithKline group of companies.

Made in Switzerland

©2011

101119XB

Nicotine Lozenge Walgreens Cherry 2mg 72 ct carton

PRINCIPAL DISPLAY PANEL

NDC 0363-9171-02

Nicotine Lozenge

Walgreens

Nicotine Polacrilex Lozenge, 4mg

STOP SMOKING AID

Mint Flavor

72 LOZENGES, 4mg EACH (3 Vials of 24)

Compare to Nicorette®* Lozenge

Includes User’s Guide

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicotine Polacrilex Lozenge, 2mg

  • • not for sale to those under 18 years of age
  • • proof of age required
  • • not for sale in vending machines or from any source where proof of age cannot be verified

TAMPER EVIDENT FEATURE: Do not use if clear neckband printed "SEALED FOR SAFETY" is missing or broken.

Retain outer carton for full product uses, directions and warnings.

TO INCREASE YOUR SUCCESS IN QUITTING:

  • •You must be motivated to quit.
  • • Use Enough – Use at least 9 lozenges per day during the first six weeks.
  • • Use Long Enough – Use for the full 12 weeks.
  • • Use With a Support Program as directed in the enclosed User’s Guide.

To open vial, push in child resistant band on the vial with thumb.

Flip up the top of the vial and remove lozenge. A small amount of powder on opening of the vial is normal.

Comments/questions:

GCSP 5.4376.4C Re: Consumer Relations, PO Box 13398

Research Triangle Park, NC 27709-9627

*NICORETTE® is a registered trademark of the GlaxoSmithKline group of companies.

Made in Switzerland

©2011

101137XA

Nicotine Lozenge Walgreens Mint 4mg 72 ct carton

PRINCIPAL DISPLAY PANEL

NDC 0363-9170-02

Nicotine Lozenge

Walgreens

Nicotine Polacrilex Lozenge, 2mg

STOP SMOKING AID

Mint Flavor

72 LOZENGES, 2mg EACH (3 Vials of 24)

Compare to Nicorette®* Lozenge

Includes User’s Guide

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicotine Polacrilex Lozenge, 4mg

  • • not for sale to those under 18 years of age
  • • proof of age required
  • • not for sale in vending machines or from any source where proof of age cannot be verified

TAMPER EVIDENT FEATURE: Do not use if clear neckband printed "SEALED FOR SAFETY" is missing or broken.

Retain outer carton for full product uses, directions and warnings.

TO INCREASE YOUR SUCCESS IN QUITTING:

  • •You must be motivated to quit.
  • • Use Enough – Use at least 9 lozenges per day during the first six weeks.
  • • Use Long Enough – Use for the full 12 weeks.
  • • Use With a Support Program as directed in the enclosed User’s Guide.

To open vial, push in child resistant band on the vial with thumb.

Flip up the top of the vial and remove lozenge. A small amount of powder on opening of the vial is normal.

Comments/questions:

GCSP 5.4376.4C Re: Consumer Relations, PO Box 13398

Research Triangle Park, NC 27709-9627

*NICORETTE® is a registered trademark of the GlaxoSmithKline group of companies.

Made in Switzerland

©2011

101141XA

Nicotine Lozenge Walgreens Mint 2mg 72 ct carton