NICOTINE- nicotine patch 
Rugby Laboratories

----------

Nicotine Transdermal System

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

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

Other information

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.

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.

*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

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)

Revised: 6/2024
Document Id: 1a266044-8837-71cc-e063-6394a90afcc0
Set id: 2dd4cbda-5c46-4655-b69d-21b7d2e912cf
Version: 16
Effective Time: 20240605
 
Rugby Laboratories