Label: NICOTINE POLACRILEX lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 3, 2025

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

  • Active ingredient (in each lozenge)
    Nicotine polacrilex, 2 mg (nicotine)
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • Other information
    • store at 20-25°C (68-77°F) • keep vial tightly closed and protect from light
  • Inactive ingredients
    acesulfame potassium, calcium polycarbophil, magnesium stearate, mannitol, natural and artificial mint flavor, potassium bicarbonate, sodium alginate, sodium carbonate, sucralose, xanthan ...
  • Questions or comments?
    call toll-free 1-866-751-9303
  • Consumer Information
    Nicotine Polacrilex Lozenge - 2 mg and 4 mg User's Guide - mini Lozenge - How to Use Mini Nicotine Polacrilex Lozenges and Tips to Help You Quit Smoking. • Not for sale to those under 18 years ...
  • HOW SUPPLIED
    Nicotine Polacrilex Lozenge 2 mg (nicotine) Stop Smoking Aid - NDC 72162-2287-2 : 81 Lozenges (3 mini QuitTube Containers of 27) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA ...
  • PRINCIPAL DISPLAY PANEL
    Nicotine Polacrilex Lozenge 2 mg (nicotine) Stop Smoking Aid - Extended Label
  • INGREDIENTS AND APPEARANCE
    Product Information