Label: MINI NICOTINE- nicotine polacrilex lozenge
- NDC Code(s): 0536-1241-27, 0536-1241-81
- Packager: Rugby Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 3, 2024
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
- 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 (4 mg 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 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. 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
- Inactive ingredients
- Questions or comments?
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Principal Display Panel (4 mg lozenge)
Compare to the active ingredient in Nicorette® mini Lozenge*
NICOTINE
Mini Lozenge
Nicotine Polacrilex 4 mg
Stop Smoking Aid
Mint Flavor
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 2 mg Lozenge.
LOZENGES, 4 mg Each (Vials)
TO INCREASE YOUR SUCCESS IN QUITTING:
1. You must be motivated to quit.
2.Use Enough - Use at least 9 Nicotine mini lozenges per day during the first six weeks.
3.Use Long Enough - Use Nicotine mini lozenges for the full 12 weeks.
4. Use With a Support Program as directed in the enclosed User's Guide.
- not for sale to those under 18 years of age
- proof of age required
- 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® mini Lozenge.
See inside for more details or visit www.nitthehabit.com
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
RETAIN OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed By:
RUGBY LABORATORIES
17177 N Laurel Park, Drive, Suite 233
Livonia, MI 48152
- Package Label (4 mg lozenge)
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INGREDIENTS AND APPEARANCE
MINI NICOTINE
nicotine polacrilex lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1241 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 ASPARTAME (UNII: Z0H242BBR1) CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) MALTODEXTRIN (UNII: 7CVR7L4A2D) MANNITOL (UNII: 3OWL53L36A) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) TALC (UNII: 7SEV7J4R1U) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color white Score no score Shape OVAL Size 10mm Flavor MINT Imprint Code 131 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1241-81 3 in 1 BOX 07/31/2019 1 27 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:0536-1241-27 1 in 1 BOX 07/31/2019 2 27 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 ANDA207868 07/31/2019 Labeler - Rugby Laboratories, Inc. (079246066)
