Label: NICOTINE patch

  • NDC Code(s): 0536-5894-53, 0536-5894-88, 0536-5895-53, 0536-5895-71, view more
    0536-5895-88, 0536-5896-53, 0536-5896-71, 0536-5896-88
  • Packager: Rugby Laboratories
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 5, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 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.
    • an allergy to adhesive tape or have skin problems, because you are more likely to get rashes.
    • 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 a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

    When using this product

    • if you have vivid dreams or other sleep disturbances, remove the patch at bedtime

    Stop use and ask a doctor if

    • skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash
    • irregular heartbeat or palpitations occur
    • you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, 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

    Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center 1-800-222-1222 right away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

  • 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 your quit day
    • If you smoke more than 10 cigarettes per day, use the following schedule below:
    Weeks 1 thru 4Weeks 5 and 6 Weeks 7 and 8
     Step 1Step 2Step 3
     use one 21 mg patch/day use one 14 mg patch/day use one 7 mg patch/day
    • if you smoke 10 or less cigarettes per day,start with Step 2for 6 weeks, then Step 3for 2 weeks 
    • apply one new patch every 24 hours on skin that is dry, clean, and hairless 
    • remove backing from patch and immediately press onto skin. Hold for 10 seconds. 
    • wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch. 
    • the used patch should be removed and a new one applied to a different skin site at the same time each day 
    • if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning 
    • do not wear more than one patch at a time 
    • do not cut patch in half or into smaller pieces 
    • do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours 
    • it is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.
  • Other information

    • store at 20°C-25°C (68°F-77°F)
  • Inactive ingredients

    acrylate adhesive, polyester, silicone adhesive

  • Comments or questions?

    1-877-748-1970

  • TO INCREASE YOUR SUCCESS IN QUITTING:

    1. You must be motivated to quit.
    2. Use one patch daily according to directions.
    3. It is important to complete treatment.
    4. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.
    5. Use patch with a behavioral support program, such as the one described in the enclosed booklet.
  • SPL UNCLASSIFIED SECTION

    • Not for sale to persons 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.
  • SPL UNCLASSIFIED SECTION

    For your family's protection, patches are supplied in child-resistant pouches.

    Do not use if individual pouch is open or torn.

    See self-help guide inside.

    See bottom panel for lot number and expiration date.

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Dr. Reddy's Laboratories Ltd., distributor of Habitrol®.

    AVEVA

    A DifGen Company

    Distributed by:

    RUGBY ®LABORATORIES
    Indianapolis, IN 46268
    (800) 616-2471
    www.majorpharmaceuticals.com

    rev. 12/23

  • PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg CARTON

    Rugby ®

    NDC 0536-5896-53

    COMPARE TO THE ACTIVE INGREDIENT IN HABITROL ®*

    Clear

    Nicotine

    Transdermal System 

    Patch

    21 mg

    21 mg delivered over 24 hours

    STOP SMOKING AID

    Includes Behavior Support Program with Self-Help Guide

    If you smoke MOREthan 10 cigarettes per day: Start with Step 1.

    If you smoke 10 or LESScigarettes per day: Start with Step 2.

    *Habitrol ®is a registered trademark of Novartis Consumer Health, Inc.

    STEP ONE

    7

    PATCHES

    Step 1

  • PRINCIPAL DISPLAY PANEL - STEP TWO 14 mg CARTON

    Rugby ®

    NDC 0536-5895-53

    COMPARE TO THE ACTIVE INGREDIENT IN HABITROL®*

    Clear

    Nicotine

    Transdermal System

    Patch

    14 mg

    14 mg delivered over 24 hours

    STOP SMOKING AID

    Includes Behavior Support Program with Self-Help Guide

    If you smoke MOREthan 10 cigarettes per day: Start with Step 1.

    If you smoke 10 or LESScigarettes per day: Start with Step 2.

    *Habitrol® is a registered trademark of Novartis Consumer Health, Inc.

    STEP TWO

    7

    PATCHES

    Step 2

  • PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON

    Rugby ®

    NDC 0536-5894-53

    COMPARE TO THE ACTIVE INGREDIENT IN HABITROL®*

    Clear

    Nicotine

    Transdermal System

    Patch

    7 mg

    7 mg delivered over 24 hours

    STOP SMOKING AID

    Includes Behavior Support Program with Self-Help Guide

    For use after completing Step 2

    *Habitrol ®is a registered trademark of Novartis Consumer Health, Inc.

    STEP THREE

    7

    PATCHES

    Step 3

  • INGREDIENTS AND APPEARANCE
    NICOTINE 
    nicotine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-5896
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE21 mg  in 24 h
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-5896-537 in 1 CARTON06/25/2024
    11 h in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0536-5896-8814 in 1 CARTON06/25/2024
    21 h in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0536-5896-7128 in 1 CARTON06/25/2024
    31 h in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07461206/25/2024
    NICOTINE 
    nicotine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-5895
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE14 mg  in 24 h
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-5895-537 in 1 CARTON06/25/2024
    11 h in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0536-5895-8814 in 1 CARTON06/25/2024
    21 h in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0536-5895-7128 in 1 CARTON06/25/2024
    31 h in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07461206/25/2024
    NICOTINE 
    nicotine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-5894
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE7 mg  in 24 h
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-5894-537 in 1 CARTON06/25/2024
    11 h in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0536-5894-8814 in 1 CARTON06/25/2024
    21 h in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07461206/25/2024
    Labeler - Rugby Laboratories (079246066)
    Registrant - Aveva Drug Delivery Systems, Inc. (783982093)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveva Drug Delivery Systems, Inc.783982093manufacture(0536-5896, 0536-5895, 0536-5894)