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NICOTINE TRANSDERMAL SYSTEM STEP 1

Dosage form: patch, extended release
Ingredients: NICOTINE 21mg in 24h
Labeler: Dr. Reddy's Laboratories Inc.
NDC Code: 43598-448

Drug Facts

Active ingredient Step 1 (in each patch)

Nicotine, 21 mg delivered over 24 hours

Active ingredient Step 2 (in each patch)

Nicotine, 14 mg delivered over 24 hours

Active ingredient Step 3 (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 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 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 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:

STEP 1

STEP 2

STEP 3

Use one 21 mg patch/day

Use one 14 mg patch/day

Use one 7 mg patch/day

Weeks 1-4

Weeks 5-6

Weeks 7-8

if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 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
to avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures
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 20-25°C (68-77°F)

Inactive ingredients

acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

Questions or comments?

call 1-800-585-8682

Weekdays (9am-8pm ET) or visit us at www.habitrol.com

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 behavioural 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.

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.

Principal Display Panel

Nicotine Transdermal System PATCH

21 mg delivered over 24 hours

STOP SMOKING AID

Includes: Behavior Support Programwith self-help guide

STEP 1

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

Principal Display Panel

NicotineTransdermalSystemPATCH

14 mg delivered over 24 hours

STOP SMOKING AID

Includes:Behavior Support Programwith self-help guide

STEP 2

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

Principal Display Panel

Nicotine Transdermal SystemPATCH

7 mg delivered over 24 hours

STOP SMOKING AID

Includes:Behavior Support Program with self-help guide

STEP 3

FOR USE AFTER COMPLETING STEP 2

NICOTINE   TRANSDERMAL SYSTEM STEP 1
nicotine patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-448
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE21 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
Methacrylic Acid 
Packaging
#Item CodePackage Description
1NDC:43598-448-7414 PATCH in 1 CARTON
124 h in 1 PATCH
2NDC:43598-448-2828 PATCH in 1 CARTON
224 h in 1 PATCH
3NDC:43598-448-707 PATCH in 1 CARTON
324 h in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02007605/14/2015
NICOTINE   TRANSDERMAL SYSTEM STEP 2
nicotine patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-447
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE14 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
Methacrylic Acid 
Packaging
#Item CodePackage Description
1NDC:43598-447-7414 PATCH in 1 CARTON
124 h in 1 PATCH
2NDC:43598-447-707 PATCH in 1 CARTON
224 h in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02007605/14/2015
NICOTINE   TRANSDERMAL SYSTEM STEP 3
nicotine patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-446
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE7 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
Methacrylic Acid 
Packaging
#Item CodePackage Description
1NDC:43598-446-7414 PATCH in 1 CARTON
124 h in 1 PATCH
2NDC:43598-446-707 PATCH in 1 CARTON
224 h in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02007605/14/2015
Labeler - Dr. Reddy's Laboratories Inc. (802315887)

Revised: 03/2016
 
Dr. Reddy's Laboratories Inc.

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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.

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