Nicotine NICOTINE POLACRILEX AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122 FDA Approved Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
FunFoxMeds box
Substance Nicotine
Route
ORAL
Applications
ANDA074507
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each chewing piece) Nicotine polacrilex (equal to 2 mg nicotine)
Inactive Ingredients
Inactive ingredients acesulfame potassium butylated hydroxytoluene carnauba wax flavors gum base sodium bicarbonate sodium carbonate sorbitol talc
Strengths
2 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
All Product Codes
UPC
0346122719605
UNII
6M3C89ZY6R
Packaging

Principal Display Panel Compare to Nicorette® Gum active ingredient* Nicotine Gum nicotine polacrilex gum USP, 2 mg (nicotine) Stop Smoking Aid Original Flavor Sugar-Free 2 mg each 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 TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivated to quit. 2. Use Enough - Use at least 9 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 not manufactured or distributed by Haleon group of companies, distributor of Nicorette® Gum See inside for more details or visit www.nitthehabit.com 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; Package Label GOOD NEIGHBOR PHARMACY Nicotine Gum Original Flavor Nicotine Polacrilex (equal to 2 mg nicotine)

Package Descriptions
  • Principal Display Panel Compare to Nicorette® Gum active ingredient* Nicotine Gum nicotine polacrilex gum USP, 2 mg (nicotine) Stop Smoking Aid Original Flavor Sugar-Free 2 mg each 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 TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivated to quit. 2. Use Enough - Use at least 9 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 not manufactured or distributed by Haleon group of companies, distributor of Nicorette® Gum See inside for more details or visit www.nitthehabit.com 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
  • Package Label GOOD NEIGHBOR PHARMACY Nicotine Gum Original Flavor Nicotine Polacrilex (equal to 2 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 if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you. 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 the process until most of the tingle is gone (about 30 minutes) do not eat or drink 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. 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 your 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. If you need to remove the lozenge, wrap it 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.
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. If you need to remove the lozenge, wrap it 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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