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Nicotine by Rugby Laboratories

Dosage form: patch
Ingredients: NICOTINE 7mg in 24h
Labeler: Rugby Laboratories
NDC Code: 0536-5894

Nicotine Transdermal System

Drug Facts

Active ingredient (in each patch)

Nicotine, 7 mg delivered over 24 hours


Stop smoking aid


Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking


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.

Do not use
  • If you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use nicotine patch or other nicotine-containing products

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 skin problems because you are more likely to get rashes

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
  • Do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your bloodstream for several hours after you take off the patch.
  • If you have vivid dreams or other sleep disturbances, remove this patch at bedtime

Stop use and ask a doctor if
  • Skin redness caused by the patch does not go away after four days, or 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

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 right away. Save pouch to use for patch disposal. Dispose of used patch by folding sticky ends together and putting in pouch.

  • 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
  • Stop smoking completely when you begin using the patch
  • If you smoke more than 10 cigarettes per day, use the following schedule:
 Weeks 1 thru 4  Weeks 5 and 6  Weeks 7 and 8
 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 2 for 6 weeks, then Step 3 for 2 weeks and then stop
  • 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 used patch 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
  • Stop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.

Other information
  • Store at 20°-25°C (68° -77°F)

Inactive ingredients

acrylate adhesive, polyester, silicone adhesive

Comments or questions?

Call 1-877-440-7867 8 AM -8 PM ET, Monday-Friday

This product is not affiliated with Novartis Consumer Health, Inc.

Principal Display Panel

Principal Display Panel - Step 3 – 7 mg Carton Label


NDC 0536-5894-88




Transdermal System

7 mg delivered over 24 hours


7 mg

Includes Behavior Support Program with Self-Help Guide

Free Audio CD upon request.


If you smoke MORE than 10 cigarettes per day: Start with Step 1

If you smoke 10 or LESS cigarettes per day: Start with Step 2

14 Patches

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

Principal Display Panel - Step 3 – 7 mg Pouch Label

7 mg delivered over 24 hours
7 mg



nicotine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-5894
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage Description
1NDC:0536-5894-8814 POUCH in 1 CARTON
1NDC:0536-5894-331 PATCH in 1 POUCH
124 h in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Labeler - Rugby Laboratories (079246066)

Revised: 08/2014
Rugby Laboratories

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.