NICORETTE- nicotine polacrilex lozenge 
Carilion Materials Management

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Drug Facts

Active ingredient (in each lozenge)(2mg)

Nicotine polacrilex, 2 mg

Active ingredient (in each lozenge)(4mg)

Nicotine polacrilex, 4 mg

Purpose

Stop smoking aid

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.

Ask a doctor before use if you have

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 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 and rapid heartbeat
you have symptoms of an allergic reaction (such as difficulty breathing or rash)

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.

Directions (2mg Lozenge)

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 1to 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.

Directions (4mg Lozenge)

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 more than 30 minutes after waking up, use 2 mg nicotine lozenge
if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1to 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.

Other information

each lozenge contains: sodium, 5 mg
store at 20 – 25oC (68 – 77oF)
keep vial tightly closed and protect from light

Inactive ingredients

acesulfame potassium, calcium polycarbophil, flavors, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

Questions or comments?

call toll-free 1-888-569-1743

HOW SUPPLIED

Product: 68151-5980

NDC: 68151-5980-1 1 LOZENGE in a BLISTER PACK

NICORETTE (NICOTINE POLACRILEX) LOZENGE

Label Image
NICORETTE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68151-5980(NDC:0135-0508)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeOVALSize10mm
FlavorMINTImprint Code M
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68151-5980-11 in 1 BLISTER PACK; Type 0: Not a Combination Product12/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02236003/01/2010
Labeler - Carilion Materials Management (079239644)
Establishment
NameAddressID/FEIBusiness Operations
Carilion Materials Management079239644REPACK(68151-5980)

Revised: 2/2018
Document Id: 62c04eb3-1970-4f9e-a94d-4e8fecbd0bd9
Set id: e5f70dda-dd7a-49d4-992f-fb28b4bf0efc
Version: 4
Effective Time: 20180206
 
Carilion Materials Management