Label: NICOTINE- nicotine lozenge
- NDC Code(s): 59779-424-03, 59779-424-05
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each lozenge)
Nicotine polacrilex, 4 mg (nicotine)Close
Stop smoking aidClose
- reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
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.
- 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 6 Weeks 7 to 9 Weeks 10 to 12
1 lozenge every1 to 2 hours
1 lozenge every2 to 4 hours
1 lozenge every4 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 gumClose
- Questions or comments?
call toll-free 1-866-751-9303Close
- Principal Display Panel
Compare to the active ingredient in Commit®
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
4 mg each
(# QuitTube™ Containers of # )
Nicotine Polacrilex Lozenge 4 mg (nicotine) Carton
- INGREDIENTS AND APPEARANCE
nicotine polacrilex lozenge
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-424 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 4 mg Product Characteristics Color WHITE Score no score Shape ROUND Size 16mm Flavor CINNAMON Imprint Code L424 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-424-05 3 in 1 CARTON 1 NDC:59779-424-03 24 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090821 05/12/2010 Labeler - CVS Pharmacy (062312574)