Nicotine Polacrilex coated Ice Mint 2 Mg And 4 Mg - Amerisourcebergen

Nicotine Polacrilex coated Ice Mint 2 Mg And 4 Mg - Amerisourcebergen
SPL v13
SPL
SPL Set ID c21147f5-da96-424c-9058-24eb751b64ea
Route
BUCCAL
Published
Effective Date 2024-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (2 mg)
Inactive Ingredients
Acacia Acesulfame Potassium Carnauba Wax Hydroxypropyl Cellulose, Unspecified Magnesium Oxide Sodium Bicarbonate Sodium Carbonate Talc Titanium Dioxide Xylitol D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Shape: square Color: white Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2018-01-09

Description

Nicotine polacrilex (equal to 2 mg nicotine)

Purpose

Stop smoking aid


Medication Information

Purpose

Stop smoking aid

Description

Nicotine polacrilex (equal to 2 mg nicotine)

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.

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 prov

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.

Package Label 2 Mg
GOOD NEIGHBOR PHARMACY Nicotine Gum Coated Ice Mint Flavor
Package Label 4 Mg
GOOD NEIGHBOR PHARMACY Nicotine Gum Coated Ice Mint Flavor
Other Information 2 Mg
  • each piece contains: calcium 115 mg, sodium 8 mg
  • store at 20 - 25ºC (68 - 77ºF)

  • protect from light

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Other Information 4 Mg
  • each piece contains: calcium 120 mg, sodium 8 mg
  • store at 20 - 25ºC (68 - 77ºF)

  • protect from light

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, xylitol.

Inactive  Ingredients 2 Mg

acacia, acesulfame potassium, carnauba wax, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide, xylitol.

Principal Display Panel 2 Mg

Compare to Nicorette® Gum active ingredient*

Sugar Free 2 mg

Nicotine Gum

Nicotine Polacrilex Gum  USP, 2 mg (nicotine)Stop Smoking Aid

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

Coated Ice Mint

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.

  • 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 not manufactured or distributed by Haleon group of companies, distributor of Nicorette® Gum.

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN

Distributed By

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 19428

Principal Display Panel 4 Mg

Compare to Nicorette® Gum active ingredient*

Sugar Free 4 mg

Nicotine Gum

Nicotine Polacrilex Gum USP, 4 mg (nicotine)

Stop Smoking Aid

FOR THOSE WHO SMOKE THEIR FIRST CIGERATTE 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

Coated Ice Mint

4 mg

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.

  • Not for sale to those under 18 years of age.
  • Proof of age required.
  • Not for sale in vending machine or from any source where proof of age cannot be verified.

*This product is not manufactured or distributed by Haleon group of companies, Distributor of Nicorette® Gum.

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN

Distributed By

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 19428

www.mygnp.com

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)

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

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 (0-800-222-1222) right away.

Active Ingredient (in Each Chewing Piece) 2 Mg

Nicotine polacrilex (equal to 2 mg nicotine)

Active Ingredient (in Each Chewing Piece) 4 Mg

Nicotine polacrilex (equal to 4 mg nicotine)

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. 


Structured Label Content

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

Purpose

Stop smoking aid

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.

Directions 2 Mg (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 prov

Directions 4 Mg (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.

Package Label 2 Mg (Package label 2 mg)
GOOD NEIGHBOR PHARMACY Nicotine Gum Coated Ice Mint Flavor
Package Label 4 Mg (Package label 4 mg)
GOOD NEIGHBOR PHARMACY Nicotine Gum Coated Ice Mint Flavor
Other Information 2 Mg (Other information 2 mg)
  • each piece contains: calcium 115 mg, sodium 8 mg
  • store at 20 - 25ºC (68 - 77ºF)

  • protect from light

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Other Information 4 Mg (Other information - 4 mg)
  • each piece contains: calcium 120 mg, sodium 8 mg
  • store at 20 - 25ºC (68 - 77ºF)

  • protect from light

Inactive Ingredients 4 Mg (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, xylitol.

Inactive  Ingredients 2 Mg (Inactive  ingredients 2 mg)

acacia, acesulfame potassium, carnauba wax, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide, xylitol.

Principal Display Panel 2 Mg (Principal display panel 2 mg)

Compare to Nicorette® Gum active ingredient*

Sugar Free 2 mg

Nicotine Gum

Nicotine Polacrilex Gum  USP, 2 mg (nicotine)Stop Smoking Aid

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

Coated Ice Mint

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.

  • 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 not manufactured or distributed by Haleon group of companies, distributor of Nicorette® Gum.

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN

Distributed By

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 19428

Principal Display Panel 4 Mg (Principal display panel 4 mg)

Compare to Nicorette® Gum active ingredient*

Sugar Free 4 mg

Nicotine Gum

Nicotine Polacrilex Gum USP, 4 mg (nicotine)

Stop Smoking Aid

FOR THOSE WHO SMOKE THEIR FIRST CIGERATTE 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

Coated Ice Mint

4 mg

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.

  • Not for sale to those under 18 years of age.
  • Proof of age required.
  • Not for sale in vending machine or from any source where proof of age cannot be verified.

*This product is not manufactured or distributed by Haleon group of companies, Distributor of Nicorette® Gum.

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN

Distributed By

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 19428

www.mygnp.com

Stop Use and Ask A Doctor If (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)

Ask A Doctor Before Use If You Have (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

Keep Out of Reach of Children and Pets. (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 (0-800-222-1222) right away.

Active Ingredient (in Each Chewing Piece) 2 Mg (Active ingredient (in each chewing piece) - 2 mg)

Nicotine polacrilex (equal to 2 mg nicotine)

Active Ingredient (in Each Chewing Piece) 4 Mg (Active ingredient (in each chewing piece) - 4 mg)

Nicotine polacrilex (equal to 4 mg nicotine)

Ask A Doctor Or Pharmacist Before Use If You Are (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. 


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