Nicotine polacrilex description, usages, side effects, indications, overdosage, supplying and lots more!

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Nicotine polacrilex

Kroger Company
GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Nicotine polacrilex (equal to 2mg nicotine)

Nicotine polacrilex (equal to 4mg nicotine)

Stop smoking aid

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

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.

Do not use

  • •if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products

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

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.

  • 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
  • •stop smoking completely when you begin using the gum
  • if you smoke your first cigarette within 30 minutes of waking up, use 4mg nicotine gum
  • if you smoke your first cigarette more than 30 minutes after waking up, use 2mg 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. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor.
  • 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
  • •stop smoking completely when you begin using the gum
  • if you smoke your first cigarette more than 30 minutes after waking up, use 2mg nicotine gum
  • if you smoke your first cigarette within 30 minutes of waking up, use 4mg 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. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor.
  • each piece contains: calcium 94mg, sodium 11mg
  • •store at 20 - 25°C (68 - 77°F)
  • •protect from light
  • each piece contains: calcium 94mg, sodium 13mg
  • •store at 20 - 25°C (68 - 77°F)
  • •protect from light
  • each piece contains: calcium 94mg, sodium 11mg
  • • store at 20 - 25°C (68 - 77°F)
  • •protect from light
  • each piece contains: calcium 94mg, sodium 13mg
  • •store at 20 - 25°C (68 - 77°F)
  • •protect from light
  • each piece contains: calcium 94mg, sodium 13mg
  • •store at 20 - 25°C (68 - 77°F)
  • •protect from light
  • each piece contains: calcium 94mg, sodium 14mg
  • •store at 20 - 25°C (68 - 77°F)
  • •protect from light
  • each piece contains: calcium 117mg, sodium 13 mg
  • •store at 20 - 25°C (68 - 77°F)
  • •protect from light
  • each piece contains: calcium 117mg, sodium 13mg
  • •store at 20 - 25°C (68 - 77°F)
  • •protect from light

acacia, acesulfame potassium, carnauba wax, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, titanium dioxide, xylitol

acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, titanium dioxide, xylitol

acacia, acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol

acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

acesulfame potassium, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, xylitol

acesulfame potassium, D&C yellow #10 Al. lake, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, xylitol

flavors, glycerin, gum base, sodium bicarbonate, sodium carbonate, sorbitol

D&C yellow #10, flavors, glycerin, gum base, sodium carbonate, sorbitol

call toll-free 1-800-491-1830 (English/Spanish) weekdays (9:00 am - 4:30 pm ET)

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

This product is protected in sealed blisters. Do not use if individual blisters orprinted backings are broken, open, or torn.

*NICORETTE is a registered trademark of GlaxoSmithKline group of companies, Wilmington, DE 19808.

GlaxoSmithKline group of companies is not affiliated with The Kroger Co.

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202, Made in Sweden

QUALITY GUARANTEED

If you are not completely satisfied with this product, return it for a refund or replacement.

Free Audio CD upon request. See inside.

Principal Display Panel

NDC 30142-916-03

Nicotine polacrilex Gum, 2mg

Kroger ®

QUALITY GUARANTEED

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, 4 mg

ACTUAL SIZE

Mint Gum

100 PIECES, 2 mg each

COMPARE TO active ingredient in NICORETTE® FRESH MINT™ GUM

*See side panel

COATED GUM

©2011

101472XA

Principal Display Panel

NDC 30142-918-03

Nicotine polacrilex Gum, 4mg

Kroger ®

QUALITY GUARANTEED

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, 2 mg

ACTUAL SIZE

Mint Gum

100 PIECES, 4 mg each

COMPARE TO active ingredient in NICORETTE® FRESH MINT™ GUM

*See side panel

COATED GUM

©2011

101473XB

Prinicipal Display Panel

NDC 30142-914-03

Nicotine polacrilex Gum, 2mg

Kroger ®

QUALITY GUARANTEED

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, 4 mg

ACTUAL SIZE

Fruit Wave Gum

COATED FOR BURSTING FLAVOR

100 PIECES, 2 mg each

COMPARE TO active ingredient in NICORETTE® FRUIT CHILL™ GUM

*See side panel

COATED GUM

©2011

101470XA

Principal Display Panel

NDC 30142-915-03

Nicotine polacrilex Gum, 4mg

Kroger ®

QUALITY GUARANTEED

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, 2 mg

ACTUAL SIZE

Fruit Wave Gum

COATED FOR BURSTING FLAVOR

100 PIECES, 4 mg each

COMPARE TO active ingredient in NICORETTE® FRUIT CHILL™ GUM

*See side panel

COATED GUM

©2012

101471XB

Principal Display Panel

NDC 30142-912-02

Nicotine polacrilex Gum, 2mg

Kroger ®

QUALITY GUARANTEED

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, 4 mg

ACTUAL SIZE

Mint Gum

110 PIECES, 2 mg each

COMPARE TO active ingredient in NICORETTE® MINT GUM

*See side panel

UNCOATED GUM

©2011

101468XA

Principal Display Panel

NDC 30142-913-02

Nicotine polacrilex Gum, 4mg

Kroger ®

QUALITY GUARANTEED

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, 2 mg

ACTUAL SIZE

Mint Gum

110 PIECES, 4 mg each

COMPARE TO active ingredient in NICORETTE® MINT GUM

*See side panel

UNCOATED GUM

©2011

101469XA

Principal Display Panel

NDC 30142-910-02

Nicotine polacrilex Gum, 2mg

Kroger ®

QUALITY GUARANTEED

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, 4 mg

Original Gum

110 PIECES, 2 mg each

COMPARE TO active ingredient in NICORETTE® ORIGINAL GUM

*See side panel

UNCOATED GUM

©2012

101466XB

Principal Display Panel

NDC 30142-911-02

Nicotine polacrilex Gum, 4mg

Kroger ®

QUALITY GUARANTEED

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, 2 mg

Original Gum

110 PIECES, 4 mg each

COMPARE TO active ingredient in NICORETTE® ORIGINAL GUM

*See side panel

UNCOATED GUM

©2011

101467XA

Nicotine polacrilex

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-916
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 2 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
carnauba wax
magnesium oxide
MENTHOL
PEPPERMINT OIL
SODIUM BICARBONATE
SODIUM CARBONATE
titanium dioxide
Xylitol

Product Characteristics

Color Size Imprint Code Shape
WHITE (Beige) 14 mm N2 SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:30142-916-03 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 2011-07-26


Nicotine polacrilex

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-918
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 4 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
carnauba wax
D&C YELLOW NO. 10
ALUMINUM OXIDE
magnesium oxide
MENTHOL
PEPPERMINT OIL
SODIUM CARBONATE
titanium dioxide
Xylitol

Product Characteristics

Color Size Imprint Code Shape
YELLOW 14 mm N4 SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:30142-918-03 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 2011-08-17


Nicotine polacrilex

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-914
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 2 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
carnauba wax
HYPROMELLOSES
magnesium oxide
MENTHOL
PEPPERMINT OIL
polysorbate 80
SODIUM BICARBONATE
SODIUM CARBONATE
Sucralose
titanium dioxide
Xylitol

Product Characteristics

Color Size Imprint Code Shape
WHITE (Beige) 14 mm N2 SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:30142-914-03 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 2011-08-04


Nicotine polacrilex

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-915
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 4 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
ACACIA
ACESULFAME POTASSIUM
carnauba wax
D&C YELLOW NO. 10
ALUMINUM OXIDE
HYPROMELLOSES
magnesium oxide
MENTHOL
PEPPERMINT OIL
polysorbate 80
SODIUM CARBONATE
Sucralose
titanium dioxide
Xylitol

Product Characteristics

Color Size Imprint Code Shape
YELLOW 14 mm N4 SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:30142-915-03 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 2011-08-04


Nicotine polacrilex

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-912
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 2 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
ACESULFAME POTASSIUM
magnesium oxide
MENTHOL
PEPPERMINT OIL
SODIUM BICARBONATE
SODIUM CARBONATE
Xylitol

Product Characteristics

Color Size Shape
WHITE (Beige) 14 mm SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:30142-912-02 11 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 2011-08-04


Nicotine polacrilex

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-913
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 4 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
ACESULFAME POTASSIUM
D&C YELLOW NO. 10
ALUMINUM OXIDE
magnesium oxide
MENTHOL
PEPPERMINT OIL
SODIUM CARBONATE
Xylitol

Product Characteristics

Color Size Shape
YELLOW 14 mm SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:30142-913-02 11 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 2011-08-04


Nicotine polacrilex

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-910
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 2 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
GLYCERIN
SODIUM BICARBONATE
SODIUM CARBONATE
sorbitol

Product Characteristics

Color Size Shape
WHITE (Beige) 14 mm SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:30142-910-02 11 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018612 2011-08-04


Nicotine polacrilex

nicotine polacrilex GUM, CHEWING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-911
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 4 mg

Inactive Ingredients

Ingredient Name Strength
POLACRILIN
D&C YELLOW NO. 10
GLYCERIN
SODIUM CARBONATE
sorbitol

Product Characteristics

Color Size Shape
YELLOW 14 mm SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:30142-911-02 11 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020066 2011-08-04


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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