Your browser does not support JavaScript! NICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]
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RxNorm Names

NICOTINE (nicotine polacrilex) lozenge
[CVS Pharmacy]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active ingredient (in each lozenge)

Nicotine polacrilex, 4 mg (nicotine)

Purpose

Stop smoking aid

Uses

  • 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.

Do not use

  • if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing product

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

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

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

  • 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
  • stop smoking completely when you begin using the lozenge
  • 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 1 to 6Weeks 7 to 9Weeks 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 (about 20-30 minutes). 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 (about 20-30 minutes)
  • 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.
  • stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.

Other information

  • each lozenge contains: sodium 14 mg
  • sugar alcohol content: 1 g mannitol per lozenge
  • store at 20-25°C (68-77°F)
  • keep vial closed and protect from light

Inactive ingredients

acesulfame potassium, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, sucralose, xanthan gum

Questions or comments?

call toll-free 1-866-751-9303

Principal Display Panel

Compare to the active ingredient in Commit®

Quit Tube

New!

Nicotine Polacrilex Lozenge 4 mg (nicotine)

Stop Smoking Aid

Includes User’s Guide

For those who smoke their first cigarette within 30 minutes of waking up.

If you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Lozenge, 2 mg

Cinnamon

4 mg each

(# QuitTube™ Containers of # )

4 mg

Nicotine Polacrilex Lozenge 4 mg (nicotine) Carton

Nicotine Polacrilex Lozenge 4 mg (nicotine) Carton

NICOTINE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-424
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE4 mg
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize16mm
FlavorCINNAMONImprint Code L424
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-424-053 in 1 CARTON
1NDC:59779-424-0324 in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09082105/12/2010
Labeler - CVS Pharmacy (062312574)

Revised: 5/2010
 
CVS Pharmacy

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