Nicotine Mini NICOTINE POLACRILEX KROGER COMPANY FDA Approved Use • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
FunFoxMeds bottle
Substance Nicotine
Route
ORAL
Applications
ANDA203690

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each lozenge) Nicotine polacrilex 2 mg (nicotine)
Inactive Ingredients
Inactive ingredients acesulfame potassium calcium polycarbophil magnesium stearate mannitol natural and artificial mint flavor potassium bicarbonate sodium alginate sodium carbonate sucralose xanthan gum
Strengths
2 mg
Treats Conditions
Use Reduces Withdrawal Symptoms Including Nicotine Craving Associated With Quitting Smoking
Pill Appearance
Shape: oval Color: white Imprint: L734

Identifiers & Packaging

Container Type BOTTLE
UPC
0012345678905
UNII
6M3C89ZY6R
Packaging

Principal Display Panel COMPARE TO the active ingredient of NICORETTE ® MINI LOZENGE See side panel OUR PHARMACIST RECOMMENDED Nicotine Mini Lozenge Nicotine Polacrilex Lozenge 2mg (nicotine) STOP SMOKING AID 3 QuitTube ® Containers Inside Includes User’s Guide 2mg 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 Lozenge, 4 mg Mint Flavor actual size 81 LOZENGES/2mg EACH (3 Mini QuitTube ® Containers of 27) mini nicotine lozenge image

Package Descriptions
  • Principal Display Panel COMPARE TO the active ingredient of NICORETTE ® MINI LOZENGE See side panel OUR PHARMACIST RECOMMENDED Nicotine Mini Lozenge Nicotine Polacrilex Lozenge 2mg (nicotine) STOP SMOKING AID 3 QuitTube ® Containers Inside Includes User’s Guide 2mg 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 Lozenge, 4 mg Mint Flavor actual size 81 LOZENGES/2mg EACH (3 Mini QuitTube ® Containers of 27) mini nicotine lozenge image

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 lozenge on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours • nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. • it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

Warnings & Precautions
Warnings
Purpose

Purpose Stop smoking aid

Stop Use & Ask a Doctor

Stop use and ask a doctor if • mouth problems occur • persistent indigestion or severe sore throat occurs • irregular heartbeat or palpitations occur • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness or 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. Nicotine lozenges 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 right away. (1-800-222-1222)

Storage & Handling

Other information • store at 20-25°C (68-77°F) • keep vial tightly closed and protect from light

Questions

Questions or comments? call toll-free 1-866-751-9303


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