Label: NICOTINE- nicotine polacrilex lozenge
- NDC Code(s): 46122-732-08, 46122-732-62
- Packager: AmerisourceBergen (Good Neighbor Pharmacy) 46122
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each lozenge)
- Purpose
- Use
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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
- 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
- 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)
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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 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 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 to 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 to 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.
- 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
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to Nicorette® Lozenge active ingredient*
Nicotine Lozenges
nicotine polacrilex lozenge, 4 mg (nicotine)
Stop Smoking Aid
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 2 mg Nicotine Polacrilex Lozenge.
LOZENGES
TO INCREASE YOUR SUCCESS IN QUITTING:
1. You must be motivated to quit.
2. Use Enough - Use at least 9 Nicotine Polacrilex lozenges per day during the first six weeks.
3. Use Long Enough - Use Nicotine Polacrilex lozenges for the full 12 weeks.
4. Use With a Support Program as directed in the enclosed User's Guide.
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not for sale to those under 18 years of age
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proof of age required
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not for sale in vending machines or from any source where proof of age cannot be verified
*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P., distributor of Nicorette® Lozenge
TAMPER EVIDENT FEATURE: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
RETAIN OUTER CARTON FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS.
Distributed by:
AmerisourceBergen
1 West First Avenue,
Conshohocken, PA 19428
www.mygnp.com
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not for sale to those under 18 years of age
- Package Label
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INGREDIENTS AND APPEARANCE
NICOTINE
nicotine polacrilex lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-732 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 4 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) POVIDONE (UNII: FZ989GH94E) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM CARBONATE (UNII: 45P3261C7T) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color white (off white) Score no score Shape ROUND Size 16mm Flavor MINT Imprint Code A754 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-732-08 3 in 1 BOX 02/24/2023 1 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:46122-732-62 1 in 1 BOX 02/24/2023 2 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209206 02/24/2023 Labeler - AmerisourceBergen (Good Neighbor Pharmacy) 46122 (007914906)
