NICOTINE POLACRILEX ORIGINAL FLAVOR- nicotine polacrilex gum, chewing NICOTINE POLACRILEX ORIGIANL FLAVOR- nicotine polacrilex

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

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Active ingredient:
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)
Available from:
Publix Supermarkets, Inc.
Administration route:
BUCCAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stop smoking aid - reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking - a sodium-restricted diet - heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. - high blood pressure not controlled with medication. Nicotine can increase 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, teeth, or jaw problems occur - irregular heartbeat or palpitations occur - you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat - you have symptoms of an allergic reaction (such as difficulty breathing or rash)
Authorization status:
Abbreviated New Drug Application
Authorization number:
56062-608-62, 56062-609-62

NICOTINE POLACRILEX ORIGINAL FLAVOR- nicotine polacrilex gum, chewing

NICOTINE POLACRILEX ORIGIANL FLAVOR- nicotine polacrilex gum, chewing

Publix Supermarkets, Inc.

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Nicotine Polacrilex Gum 2 mg and 4 mg Original Flavor - Publix

Drug Facts

Active ingredient (in each chewing piece) - 2 mg

Nicotine Polacrilex 2 mg (nicotine)

Active ingredient (in each chewing piece) - 4 mg

Nicotine Polacrilex 4 mg (nicotine)

Purpose

Stop smoking aid

Use

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

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

a sodium-restricted diet

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

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

stomach ulcer or diabetes

history of seizures

Ask a doctor or pharmacist before use if you are

using a non-nicotine stop smoking drug

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

adjusted.

Stop use and ask a doctor if

mouth, teeth, or jaw problems occur

irregular heartbeat or palpitations occur

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

rapid heartbeat

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

Keep out of reach of children and pets.

Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of

gum 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

if you are under 18 years of age, ask a doctor before use

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

important information

begin using the gum on your quit day

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

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

according to the following 12 week schedule:

Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12

1 piece every

1 to 2 hours

1 piece every

2 to 4 hours

1 piece every

4 to 8 hours

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

chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is

gone, begin chewing again, until the tingle returns.

repeat this process until most of the tingle is gone (about 30 minutes)

do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece

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

if you experience strong or frequent cravings, you may use a second piece within the hour.

However, do not continuously use one piece after another since this may cause you hiccups,

heartburn, nausea or other side effects.

do not use more than 24 pieces a day

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

from smoking, talk to your health care provider.

Directions - 4 mg

if you are under 18 years of age, ask a doctor before use

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

important information

begin using the gum on your quit day

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

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

according to the following 12 week schedule:

Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12

1 piece every

1 to 2 hours

1 piece every

2 to 4 hours

1 piece every

4 to 8 hours

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

chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is

gone, begin chewing again until the tingle returns.

repeat this process until most of the tingle is gone (about 30 minutes)

do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece

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

if you experience strong or frequent cravings, you may use a second piece within the hour.

However, do not continuously use one piece after another since this may cause you hiccups,

heartburn, nausea or other side effects.

do not use more than 24 pieces a day

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

from smoking, talk to your health care provider.

Other information - 2 mg

each piece contains: calcium 115 mg, sodium 11 mg

store at 20 - 25ºC (68 - 77ºF)

protect from light

Other information - 4 mg

each piece contains: calcium 110 mg, sodium 11 mg

store at 20 - 25ºC (68 - 77ºF)

protect from light

Inactive ingredients - 2 mg

acesulfame potassium, butylated hydroxytoluene, carnauba wax, flavors, gum base, sodium bicarbonate,

sodium carbonate, sorbitol and talc.

Inactive ingredients - 4 mg

acesulfame potassium, butylated hydroxytoluene, carnauba wax, D&C yellow #10 lake, FD&C blue #2

lake, FD&C red #40, FD&C yellow #6 lake, flavors, gum base, sodium bicarbonate, sodium

carbonate, sorbitol and talc.

Questions or comments?

Call 1-877-440-7867

TO INCREASE YOUR SUCCESS IN QUITTING:

To remove the gum, tear off single unit.

Peel off backing, starting at corner with loose edge.

Push gum through foil.

1. You must be motivated to quit.

2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six

weeks.

3. Use Long Enough - Use Nicotine Polacrilex Gum for the full 12 weeks.

4. Use with a Support Program as directed in the enclosed User's Guide.

Blister packaged for your protection.

Do not use if individual seals are open or torn.

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.

PRINCIPAL DISPLAY PANEL - 2 mg

SUGAR FREE

nicotinegum

NICOTINE POLACRILEX GUM

USP, 2 mg (nicotine)

STOP SMOKING AID

ORIGINAL FLAVOR

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 gum usp, 4 mg

2 mg110 PIECES OF GUM

2 mg EACH

*Compare to the active ingredient in Nicorette

PRINCIPAL DISPLAY PANEL - 4 mg

SUGAR FREE

nicotinegum

NICOTINE POLACRILEX GUM

USP, 4 mg (nicotine)

STOP SMOKING AID

ORIGINAL FLAVOR

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 gum usp, 2 mg

4 mg 110 PIECES OF GUM

4 mg EACH

*Compare to the active ingredient in Nicorette

NICOTINE POLACRILEX ORIGINAL FLAVOR

nicotine polacrilex gum, chewing

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:56 0 6 2-6 0 8

Route of Administration

BUCCAL

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

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

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

SO RBITO L (UNII: 50 6 T6 0 A25R)

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

WHITE (o ff-white to tan)

S core

no sco re

S hap e

SQUARE

S iz e

14mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:56 0 6 2-6 0 8 -

11 in 1 CARTON

0 1/0 1/20 14

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 7450 7

0 1/0 1/20 14

NICOTINE POLACRILEX ORIGIANL FLAVOR

nicotine polacrilex gum, chewing

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:56 0 6 2-6 0 9

Route of Administration

BUCCAL

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

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

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

SO RBITO L (UNII: 50 6 T6 0 A25R)

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

YELLOW (yello wish)

S core

no sco re

S hap e

SQUARE

S iz e

14mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:56 0 6 2-6 0 9 -

11 in 1 CARTON

0 1/0 1/20 14

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Publix Supermarkets, Inc.

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 7470 7

0 1/0 1/20 14

Labeler -

Publix Supermarkets, Inc. (006922009)

Revised: 9/2020

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