Label: MEDLINE- nicotine patch

  • NDC Code(s): 53329-191-89, 53329-192-89, 53329-193-89
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 25, 2025

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

  • Drug Fact
  • Active ingredient (in each patch)
    Nicotine, 21 mg delivered over 24 hours
  • Active ingredient (in each patch)
    Nicotine, 14 mg delivered over 24 hours
  • Active ingredient (in each patch)
    Nicotine, 7 mg delivered over 24 hours
  • 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 self-help guide for complete directions and other information - begin using the patch on ...
  • Other information
    store at 20°C-25°C (68°F-77°F)
  • Inactive ingredients
    acrylate adhesive, polyester, silicone adhesive
  • Questions or comments?
    1-877-748-1970
  • TO INCREASE YOUR SUCCESS IN QUITTING:
    You must be motivated to quit. Use one patch daily according to directions. It is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking ...
  • SPL UNCLASSIFIED SECTION
    Use after completing STEP 2 - For your family's protection, patches are supplied in child-resistant pouches. Do not use if individual pouch is open or torn. 3002895 (21 mg) 3002894 (14 ...
  • SPL UNCLASSIFIED SECTION
    REF OTCM019389 - www.medline.com ©2022 Medline Industries, LP - Medline is a registered trademark of Medline Industries, LP - Manufactured for: Medline Industries, LP, Three Lakes Drive, Northfield, IL ...
  • Principal Display Panel- 21 mg Carton
    NDC: 53329-192-89 - MEDLINE - Clear - Nicotine Transdermal Patch System - Step 1 - 21 mg - 24 hour time release - Stop smoking aid - If you smoke  - MORE than 10 cigarettes per day: Start with ...
  • Principal Display Panel- 14 mg Carton
    NDC: 53329-191-89 - MEDLINE - Clear - Nicotine Transdermal Patch System - Step 2 - 14 mg - 24 hour release - Stop smoking aid - If you smoke  - MORE than 10 cigarettes per day: Start with  - STEP ...
  • Principal Display Panel- 7 mg Carton
    NDC: 53329-193-89 - MEDLINE - Clear - Nicotine Transdermal Patch System - Step 3 - 7 mg - 24 hour release - Stop smoking aid - If you smoke  - MORE than 10 cigarettes per day: Start with  - STEP ...
  • INGREDIENTS AND APPEARANCE
    Product Information