Your browser does not support JavaScript! NICOTINE PATCH [RUGBY LABORATORIES, INC.]
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RxNorm Names

NICOTINE patch
[Rugby Laboratories, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Drug Facts

Active ingredient (in each patch)

Nicotine, 14 mg delivered over 24 hours

Purpose

Stop smoking aid

Uses

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 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 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 - 8PM ET, Monday-Friday

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

Principal Display Panel - Step 2 – 14 mg – Carton Label

Rugby®

NDC 0536-5895-88

COMPARE TO THE ACTIVE INGREDIENT IN HABITROL®*

Clear

Nicotine

Transdermal System

14 mg delivered over 24 hours

STOP SMOKING AID

14 mg

Includes Behavior Support Program with Self-Help Guide

Free Audio CD upon request.

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.

Principal Display Panel - Step 2 – 14 mg – Carton Label

Principal Display Panel - Step 2 – 14 mg Pouch Label

STEP
TWO

Nicotine
Transdermal
System
14 mg delivered over 24 hours
STOP SMOKING AID
14 mg

DO NOT OPEN POUCH
UNTIL READY TO USE.

Principal Display Panel - Step 2 – 14 mg Pouch Label
NICOTINE 
nicotine patch
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-5895
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Nicotine (Nicotine) Nicotine14 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
dimethicone 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-5895-8814 in 1 CARTON
1NDC:0536-5895-331 in 1 POUCH
124 h in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461110/20/1997
Labeler - Rugby Laboratories, Inc. (109178264)
Registrant - Aveva Drug Delivery Systems, Inc. (783982093)
Establishment
NameAddressID/FEIBusiness Operations
Aveva Drug Delivery Systems, Inc.783982093MANUFACTURE, ANALYSIS
Establishment
NameAddressID/FEIBusiness Operations
Watson Laboratories, Inc.113484526PACK

Revised: 8/2011
 
Rugby Laboratories, Inc.

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