NICORETTE- nicotine polacrilex lozenge

United States - English - NLM (National Library of Medicine)

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Active ingredient:
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)
Available from:
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stop smoking aid
Authorization status:
New Drug Application
Authorization number:
0135-0625-01, 0135-0625-02, 0135-0625-03, 0135-0626-01, 0135-0626-02, 0135-0626-03

NICORETTE- nicotine polacrilex lozenge

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

----------

Drug Facts

Active ingredient (in each lozenge) (2 mg)

Nicotine polacrilex, 2 mg

Active ingredient (in each lozenge) (4 mg)

Nicotine polacrilex, 4 mg

Purpose

Stop smoking aid

Use

Warnings

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care

provider.

Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement

medicine. This medicine is believed to be safer than smoking. However, the risks to your child from

this medicine are not fully known.

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.

high blood pressure not controlled with medication. Nicotine can increase your blood pressure.

stomach ulcer or diabetes

history of seizures

using a non-nicotine stop smoking drug

taking prescription medicine for depression or asthma. Your prescription dose may need to be

adjusted.

mouth problems occur

persistent indigestion or severe sore throat occurs

irregular heartbeat or palpitations occur

you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness

and rapid heartbeat

Keep out of reach of children and pets.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the

lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a

Poison Control Center right away.

Directions (2 mg)

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 lozenge every 1 to 2 hours

1 lozenge every 2 to 4 hours

1 lozenge every 4 to 8 hours

Directions (4 mg)

you have symptoms of an allergic reaction (such as difficulty breathing or rash)

if you are under 18 years of age, ask a doctor before use. No studies have been done to

show if this product will work for you.

before using this product, read the enclosed User’s Guide for complete directions and other

important information

begin using the lozenge on your quit day

if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge

if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine

lozenge according to the following 12 week schedule:

nicotine lozenge is a medicine and must be used a certain way to get the best results

place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing.

Do not chew or swallow lozenge.

you may feel a warm or tingling sensation

occasionally move the lozenge from one side of your mouth to the other until completely

dissolved

do not eat or drink 15 minutes before using or while the lozenge is in your mouth

to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks

do not use more than one lozenge at a time or continuously use one lozenge after another since

this may cause you hiccups, heartburn, nausea or other side effects

do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.

it is important to complete treatment. If you feel you need to use the lozenge for a longer period to

keep from smoking, talk to your health care provider.

if you are under 18 years of age, ask a doctor before use. No studies have been done to

show if this product will work for you.

before using this product, read the enclosed User’s Guide for complete directions and other

important information

begin using the lozenge on your quit day

if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine

lozenge

if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge

according to the following 12 week schedule:

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 lozenge every 1 to 2 hours

1 lozenge every 2 to 4 hours

1 lozenge every 4 to 8 hours

Other information (Ice Mint)

Inactive ingredients (Ice Mint)

acesulfame potassium, flavors, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose,

polysorbate 80, potassium aluminum silicate, sodium carbonate, xanthan gum

Questions or comments?

call toll-free 1-888-569-1743

Principal Display Panel

NDC 0135-0625-02

NEW

Nicorette

nicotine polacrilex lozenge, 2 mg stop smoking aid

Lozenge

Coated

Ice Mint

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 Nicorette 4mg Lozenge.

2 mg

80 LOZENGES, 2mg EACH

nicotine lozenge is a medicine and must be used a certain way to get the best results

place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing.

Do not chew or swallow lozenge.

you may feel a warm or tingling sensation

occasionally move the lozenge from one side of your mouth to the other until completely

dissolved

do not eat or drink 15 minutes before using or while the lozenge is in your mouth

to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks

do not use more than one lozenge at a time or continuously use one lozenge after another since

this may cause you hiccups, heartburn, nausea or other side effects

do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.

it is important to complete treatment. If you feel you need to use the lozenge for a longer period to

keep from smoking, talk to your health care provider.

store at 20 - 25°C (68 - 77°F)

Store in the original container

(4 Packs of 20)

Includes User’s Guide

TO INCREASE YOUR SUCCESS IN QUITTING:

For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.com

or see inside for more details.

TO OPEN

PUSH

LIFT

TO CLOSE

Push Cap Closed until you hear a CLICK to ensure child resistance

CLICK

Distributed By:

GlaxoSmithKline Consumer Healthcare

Warren, NJ 07059

Made in the Switzerland

Trademarks are owned by or licensed to the GSK group of companies.

©2018 GSK group of companies or its licensor.

106600XA

You must be motivated to quit.

Use Enough - Use at least 9 Nicorette Lozenges per day during the first six weeks.

Use Long Enough - Use Nicorette for the full 12 weeks.

Use With a Support Program as directed in the enclosed User’s Guide.

Principal Display Panel

NDC 0135-0626-02

NEW

Nicorette

nicotine polacrilex lozenge, 4 mg stop smoking aid

Lozenge

Coated Ice Mint

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES

AFTER WAKING UP.

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

Lozenge.

4 mg

80 LOZENGES, 2mg EACH

(4 Packs of 20)

Includes User’s Guide

TO INCREASE YOUR SUCCESS IN QUITTING:

For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.com

or see inside for more details.

TO OPEN

PUSH

LIFT

TO CLOSE

Push Cap Closed until you hear a CLICK to ensure child resistance

CLICK

Distributed By:

GlaxoSmithKline Consumer Healthcare

Warren, NJ 07059

Made in the Switzerland

Trademarks are owned by or licensed to the GSK group of companies.

©2018 GSK group of companies or its licensor.

106608XA

You must be motivated to quit.

Use Enough - Use at least 9 Nicorette Lozenges per day during the first six weeks.

Use Long Enough - Use Nicorette for the full 12 weeks.

Use With a Support Program as directed in the enclosed User’s Guide.

NICORETTE

nicotine polacrilex lozenge

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 135-0 6 25

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NICO TINE (UNII: 6 M3C8 9 ZY6 R) (NICOTINE - UNII:6 M3C8 9 ZY6 R)

NICOTINE

2 mg

Inactive Ingredients

Ingredient Name

Stre ng th

PO LACRILIN (UNII: RCZ78 5HI7S)

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MANNITO L (UNII: 3OWL53L36 A)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

PO TASSIUM (UNII: RWP5GA0 15D)

ALUMINUM SILICATE (UNII: T1FAD4SS2M)

SO DIUM CARBO NATE (UNII: 45P326 1C7T)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics

Color

WHITE (white to o ff-white)

S core

no sco re

S hap e

OVAL

S iz e

15mm

Flavor

MINT (Ice Mint)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 135-0 6 25-0 1

1 in 1 CARTON

0 4/11/20 19

1

20 in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 135-0 6 25-0 2

4 in 1 CARTON

0 4/11/20 19

2

20 in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:0 135-0 6 25-0 3

6 in 1 CARTON

10 /23/20 19

3

20 in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 21330

0 4/11/20 19

NICORETTE

nicotine polacrilex lozenge

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 135-0 6 26

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NICO TINE (UNII: 6 M3C8 9 ZY6 R) (NICOTINE - UNII:6 M3C8 9 ZY6 R)

NICOTINE

4 mg

Inactive Ingredients

Ingredient Name

Stre ng th

PO LACRILIN (UNII: RCZ78 5HI7S)

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MANNITO L (UNII: 3OWL53L36 A)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

PO TASSIUM (UNII: RWP5GA0 15D)

ALUMINUM SILICATE (UNII: T1FAD4SS2M)

SO DIUM CARBO NATE (UNII: 45P326 1C7T)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics

Color

WHITE (white to o ff-white)

S core

no sco re

S hap e

OVAL

S iz e

15mm

Flavor

MINT (Ice Mint)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 135-0 6 26 -0 1

1 in 1 CARTON

0 4/11/20 19

1

20 in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 135-0 6 26 -0 2

4 in 1 CARTON

0 4/11/20 19

2

20 in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:0 135-0 6 26 -0 3

6 in 1 CARTON

10 /23/20 19

3

20 in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 21330

0 4/11/20 19

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Labeler -

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 9/2019

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