FDA Label for Nicotac Nicotine Polacrilex Coated Mint

Other

Drug Facts

Distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW
Cedar Rapids, IA 52404

Active Ingredient (In Each Chewing Piece)

Nicotine polacrilex 2 mg (nicotine)

Purpose

Stop smoking aid

Use

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

Otc - Pregnancy Or Breast Feeding

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, a 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)

Otc - 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 right away.

Directions

• 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 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 of 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 hiccups, heartburn, nausea, or other side effects.
• do not use more than 24 pieces a day
• it is important to complete treatment. If you still feel the need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Other Information

• each piece contains: calcium 115 mg, sodium 8 mg
• store at 20–25°C (68–77°F)
• protect from light

Inactive Ingredients

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

Questions Or Comments?

call 1-877-440-7867

Principal Display Panel - 2 Mg Gum Blister Pack Carton

NICOTAC™
NICOTINE POLACRILEX GUM USP

2
mg
(nicotine)

STOP SMOKING AID

Coated
Mint Gum

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

Compare to the active ingredient in
Nicorette® Fresh Mint™ Coated Gum*

10 Pieces
Sugar Free, 2 mg Each

PRINCIPAL DISPLAY PANEL - 2 mg Gum Blister Pack Carton - nicotac 01