Nicotine Polacrilex Original NICOTINE POLACRILEX CARDINAL HEALTH (LEADER) 70000 FDA Approved Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
FunFoxMeds box
Substance Nicotine
Route
BUCCAL
Applications
ANDA074707 ANDA074507

Drug Facts

Composition & Profile

Active Ingredients
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)
Inactive Ingredients
Inactive ingredients - 2 mg acesulfame potassium butylated hydroxytoluene carnauba wax flavors gum base sodium bicarbonate sodium carbonate sorbitol 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.
Strengths
2 mg 4 mg
Treats Conditions
Use Reduces Withdrawal Symptoms Including Nicotine Craving Associated With Quitting Smoking
Pill Appearance
Shape: square Color: white

Identifiers & Packaging

Container Type BOX
UPC
0096295133837 0096295133844
UNII
6M3C89ZY6R
Packaging

Principal display panel 2 mg COMPARE TO NICORETTE® ORIGINAL GUM active ingredient* Sugar-Free Nicotine Gum Nicotine Polacrilex Gum USP, 2 mg Nicotine Stop Smoking Aid 2 mg Original Flavor For Those Who Smoke Their First Cigarette More Than 30 Minutes After Waking Up If You Smoke Their First Cigarette WITHIN 30 Minutes of Waking Up, Use Nicotine Polacrilex Gum USP,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® Original Gum. BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017; Package label 2 mg LEADER Sugar Free Nicotine Gum Original Flavor Nicotine Polacrilex (equal to 2 mg nicotine); Principal display panel 4 mg COMPARE TO NICORETTE® ORIGINAL GUM active ingredient* Sugar-Free Nicotine Gum Nicotine Polacrilex Gum USP, 4 mg (Nicotine) Stop Smoking Aid 4 mg Original Flavor For Those Who Smoke Their First Cigarette With 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 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 CARDINAL HEALTH DUBLIN, OHIO 43017; Package label 4 mg LEADER Sugar Free Nicotine Gum Original Flavor Nicotine Polacrilex (equal to 4 mg nicotine)

Package Descriptions
  • Principal display panel 2 mg COMPARE TO NICORETTE® ORIGINAL GUM active ingredient* Sugar-Free Nicotine Gum Nicotine Polacrilex Gum USP, 2 mg Nicotine Stop Smoking Aid 2 mg Original Flavor For Those Who Smoke Their First Cigarette More Than 30 Minutes After Waking Up If You Smoke Their First Cigarette WITHIN 30 Minutes of Waking Up, Use Nicotine Polacrilex Gum USP,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® Original Gum. BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017
  • Package label 2 mg LEADER Sugar Free Nicotine Gum Original Flavor Nicotine Polacrilex (equal to 2 mg nicotine)
  • Principal display panel 4 mg COMPARE TO NICORETTE® ORIGINAL GUM active ingredient* Sugar-Free Nicotine Gum Nicotine Polacrilex Gum USP, 4 mg (Nicotine) Stop Smoking Aid 4 mg Original Flavor For Those Who Smoke Their First Cigarette With 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 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 CARDINAL HEALTH DUBLIN, OHIO 43017
  • Package label 4 mg LEADER Sugar Free Nicotine Gum Original Flavor Nicotine Polacrilex (equal to 4 mg nicotine)

Overview

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

Indications & Usage

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

Dosage & Administration

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.

Warnings & Precautions
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.
Purpose

Purpose Stop smoking aid

Stop Use & Ask a Doctor

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

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 (1-800-222-1222) right away.

Questions

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST


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