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Name:Nicotine
Manufacturer:Rugby Laboratories, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Clear NicotineTransdermal System

NICOTINE - nicotine patch 
Rugby Laboratories, Inc.

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Clear Nicotine
Transdermal System

Drug Facts

Active ingredient (in each patch)

Nicotine, 14 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.

Do not use • If you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use nicotine patch or other nicotine-containing 1 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.

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
  • 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
STEP 1 STEP 2 STEP 3
use one 21 mg patch/day use one 14 mg patch/day use one 7mg 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. Mold 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-1-877-440-78678 AM - 8PM ET, Monday-Friday

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

Principal Display Panel

Step 2 – 14 mg

Rugby®

NDC 0536-5895-88

COMPARE TO THE ACTIVE INGREDIENT IN HALITROL®

Clear

Nicotine

Transdermal System

14 mg delivered over 24 hours

STOP SMOKING AID

14 mg

Includes Behavior Support Program with Self-Help Guide

STEP TWO

If you smoke MORE than 10 cigarettes per day: Use after completing 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.

Clear Nicotine Transdermal System – 14 Patches

NICOTINE 
nicotine patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-5895
Route of Administration TRANSDERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nicotine (Nicotine) Nicotine 14 mg  in 1 d
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0536-5895-88 14 POUCH (14 POUCH) in 1 CARTON contains a POUCH
1 1 PATCH (1 PATCH) in 1 POUCH This package is contained within the CARTON (0536-5895-88) and contains a PATCH
1 1 d in 1 PATCH This package is contained within a POUCH and a CARTON (0536-5895-88)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074611 10/20/1997

Labeler - Rugby Laboratories, Inc. (109178264)
Registrant - Aveva Drug Delivery Systems, Inc. (783982093)
Establishment
Name Address ID/FEI Operations
Aveva Drug Delivery Systems, Inc. 783982093 MANUFACTURE, ANALYSIS

Revised: 12/2009 Rugby Laboratories, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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