Label: NICOTINE MINI- nicotine polacrilex lozenge

  • NDC Code(s): 57237-320-42, 57237-320-72, 57237-321-42, 57237-321-72
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 9, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient (in each lozenge)

    Nicotine polacrilex 4 mg

    Nicotine polacrilex 2 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 (1-800-222-1222).

  • 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.
  • Directions (2 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 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 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

    • Phenylketonurics: Contains Phenylalanine 2.8 mg per lozenge
    • store at 20-25ºC (68-77ºF)
    • keep bottle tightly closed and protect from light
  • INACTIVE INGREDIENT

    Inactive ingredients aspartame, calcium polycarbophil, flavor, maltodextrin, mannitol, sodium alginate, sodium bicarbonate, sodium stearyl fumarate, talc, xanthan gum

  • Questions or comments?

    Call 1-844-474-7464

    Distributed by:

    Rising Pharma Holdings, Inc.

    East Brunswick, NJ 08816

    Issued: 04/2023

  • Principal Display Panel (4 mg lozenge)

    *Compare to the active ingredient in Nicorette®mini Lozenge

    Nicotine Mini Lozenge

    Stop Smoking Aid

    NICOTINE POLACRILEX LOZENGE 4 MG

    • User's Guide Included
    • 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.

    4 mg

    NDC 57237-321-42 (1 Bottle of 24)

    Mint Flavor

    LOZENGES, 4 mg Each (Bottles)

    Opening Directions:

    Push down on cap and turn to open.

    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

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    RETAIN OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

  • Package Label (4 mg lozenge)

    nicotine-lozenge-4mg-carton

    nicotine-lozenge-4mg-label

  • Principal Display Panel (2 mg lozenge)

    *Compare to the active ingredient in Nicorette® mini Lozenge

    Nicotine Mini Lozenge

    Stop Smoking Aid

    NICOTINE POLACRILEX LOZENGE 2 MG

    • User's Guide Included
    • FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.
    • If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicotine Polacrilex 4 mg Lozenge.

    2 mg

    NDC 57237-320-42 (1 Bottle of 24)

    Mint Flavor

    LOZENGES, 2 mg Each (Bottles)

    Opening Directions:

    Push down on cap and turn to open.

    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

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    RETAIN OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

  • Package Label (2 mg lozenge)

    nicotine-lozenge-2mg-carton

    nicotine-lozenge-2mg-label

  • INGREDIENTS AND APPEARANCE
    NICOTINE  MINI
    nicotine polacrilex lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-321
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScoreno score
    ShapeOVALSize10mm
    FlavorMINTImprint Code 131
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57237-321-421 in 1 BOX08/10/2023
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:57237-321-723 in 1 BOX08/10/2023
    224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20786808/10/2023
    NICOTINE  MINI
    nicotine polacrilex lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-320
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScoreno score
    ShapeOVALSize10mm
    FlavorMINTImprint Code 129
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57237-320-421 in 1 BOX08/10/2023
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:57237-320-723 in 1 BOX08/10/2023
    224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20786808/10/2023
    Labeler - Rising Pharma Holdings, Inc. (116880195)