Label: TOPCARE NICOTINE- nicotine polacrilex gum, chewing

  • NDC Code(s): 36800-029-25, 36800-029-60
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 20, 2025

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

  • Active ingredient (in each chewing piece)
    Nicotine polacrilex (equal to 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 ...
  • Directions
    • 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 - • begin using the ...
  • Other information
    • each piece contains: calcium 95 mg and sodium 11 mg - • store at 20-25oC (68-77oF) • protect from light
  • Inactive ingredients
    acesulfame potassium, calcium carbonate, carnauba wax, flavors, gum base, sodium bicarbonate, sodium carbonate anhydrous, sorbitol, talc
  • Questions or comments?
    call 1-866-677-7858
  • Consumer Information
    :02952 00 J5 - HOW TO USE NICOTINE POLACRILEX GUM TO HELP YOU QUIT SMOKING. Nicotine Polacrilex Gum - 2 mg and 4 mg User's Guide - KEYS TO SUCCESS. 1. You must really want to quit smoking for ...
  • Principal Display Panel
    TopCare® health - COMPARE TO NICORETTE® GUM ACTIVE INGREDIENT - Nicotine Gum - NICOTINE POLACRILEX GUM 2 mg (NICOTINE) STOP SMOKING AID - Icludes User’s Guide - FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE ...
  • INGREDIENTS AND APPEARANCE
    Product Information