NICOTINE POLACRILEX COATED ICE MINT- nicotine polacrilex gum, chewing NICOTINE POLACRILEX COATED ICE MINT- nicotine polacrilex

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

Buy It Now

Active ingredient:
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)
Available from:
CVS Pharmacy
Administration route:
BUCCAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stop smoking aid - reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking 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:
69842-216-15, 69842-216-16, 69842-216-44, 69842-217-15, 69842-217-16, 69842-217-44

NICOTINE POLACRILEX COATED ICE MINT- nicotine polacrilex gum, chewing

CVS Pharmacy

----------

Nicotine Polacrilex Coated Ice Mint 2 mg and 4 mg CVS

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 8 mg

store at 20 - 25ºC (68 - 77ºF)

protect from light

Other information - 4 mg

each piece contains: calcium 120 mg, sodium 8 mg

store at 20 - 25ºC (68 - 77ºF)

protect from light

Inactive ingredients - 2 mg

acacia, acesulfame potassium, carnauba wax, flavors, gum base, hydroxypropyl cellulose, magnesium

oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide and xylitol.

Inactive ingredients - 4 mg

acacia, acesulfame potassium, carnauba wax, D&C yellow #10 aluminum lake, flavors, gum base,

hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium

dioxide and xylitol.

Questions or comments?

Call 1-877-440-7867

TO INCREASE YOUR SUCCESS IN QUITTING:

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.

To remove the gum, tear off single unit.

Peel off backing starting at corner with loose edge.

Push gum through foil.

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.

Blister packaged for your protection.

Do not use if individual seals are open or torn.

Principal Display Panel - 2 mg

CVS Health

Compare to the active ingredient in Nicorette

White Ice Mint

Sugar Free

Nicotine

2 mg

Nicotine Polacrilex Gum USP,

2 mg (nicotine)

STOP SMOKING AID

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

Free Audio CD upon request.

See inside.

Coated Ice Mint

20 PIECES

2 mg EACH

Principal Display Panel - 4 mg

CVSHealth

Compare to the active ingredient in Nicorette

White Ice Mint

Sugar Free

Nicotine

4 mg

Nicotine Polacrilex Gum USP,

4 mg (nicotine)

STOP SMOKING AID

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

Free Audio CD

upon request.

See inside.

Coated Ice Mint

20 PIECES

4 mg EACH

NICOTINE POLACRILEX COATED ICE MINT

nicotine polacrilex gum, chewing

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-216

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

ACACIA (UNII: 5C540 3N26 O)

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

CARNAUBA WAX (UNII: R12CBM0 EIZ)

HYDRO XYPRO PYL CELLULO SE, UNSPECIFIED (UNII: 9 XZ8 H6 N6 OH)

MAGNESIUM O XIDE (UNII: 3A3U0 GI71G)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

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

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

SQUARE

S iz e

14mm

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 8 42-216 -44

10 0 in 1 CARTON

0 5/0 1/20 16

1

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

2

NDC:6 9 8 42-216 -15

20 in 1 CARTON

0 5/0 1/20 16

2

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

3

NDC:6 9 8 42-216 -16

16 0 in 1 CARTON

0 5/0 1/20 16

3

1 in 1 BLISTER PACK; 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

ANDA

ANDA20 479 4

0 5/0 1/20 16

NICOTINE POLACRILEX COATED ICE MINT

nicotine polacrilex gum gum, chewing

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-217

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

ACACIA (UNII: 5C540 3N26 O)

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

CARNAUBA WAX (UNII: R12CBM0 EIZ)

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

HYDRO XYPRO PYL CELLULO SE, UNSPECIFIED (UNII: 9 XZ8 H6 N6 OH)

MAGNESIUM O XIDE (UNII: 3A3U0 GI71G)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

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

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

Product Characteristics

Color

YELLOW

S core

no sco re

S hap e

SQUARE

S iz e

14mm

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 8 42-217-44

10 0 in 1 CARTON

0 5/0 1/20 16

1

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

2

NDC:6 9 8 42-217-15

20 in 1 CARTON

0 5/0 1/20 16

2

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

3

NDC:6 9 8 42-217-16

16 0 in 1 CARTON

0 5/0 1/20 16

3

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

CVS Pharmacy

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 48 33

0 5/0 1/20 16

Labeler -

CVS Pharmacy (062312574)

Revised: 11/2019

Similar products

Search alerts related to this product

View documents history

Share this information