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Nicotine Transdermal System by Walgreens

Medically reviewed on October 12, 2017

Dosage form: patch, extended release
Ingredients: Nicotine 14mg in 24h
Labeler: Walgreens
NDC Code: 0363-8001

Nicotine Transdermal System - nicotine patch, extended release

Drug Fact

Active ingredient (in each patch)  

Step 1 - Nicotine, 21 mg delivered over 24 hours

Step 2 - Nicotine, 14 mg delivered over 24 hours

Step 3 - 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.

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 blood stream 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 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

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:
    Weeks 1 thru 2Weeks 5 and 6Weeks 7 and 8
    Step 1Step 2Step 3
    Use one 21 mg patch/dayUse one 14 mg patch/dayUse 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
  • 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
  • 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° C – 25° C (68° F – 77° F)

Inactive ingredients

acrylate adhesive, polyester, silicone adhesive

Comments or Questions?

1-844-562-7963

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.

PRINCIPAL DISPLAY PANEL - 14 mg CARTON

Nicotine Transdermal System

NDC No. 0363-8001-01

14 Patches

PRINCIPAL DISPLAY PANEL - 7 mg CARTON

Nicotine Transdermal System

NDC No. 0363-8000-01

14 Patches

PRINCIPAL DISPLAY PANEL- 21 mg CARTON

Nicotine Transdermal System

NDC No. 0363-8002-02

14 Patches

NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8001
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 Description
1NDC:0363-8001-0114 POUCH in 1 CARTON
11 h in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461210/20/1997
NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8000
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Nicotine (Nicotine) Nicotine7 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
Dimethicone 
Packaging
#Item CodePackage Description
1NDC:0363-8000-0114 POUCH in 1 CARTON
11 h in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461210/20/1997
NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8002
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Nicotine (Nicotine) Nicotine21 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
Dimethicone 
Packaging
#Item CodePackage Description
1NDC:0363-8002-0214 POUCH in 1 CARTON
11 h in 1 POUCH
2NDC:0363-8002-017 POUCH in 1 CARTON
21 h in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461210/20/1997
Labeler - Walgreens (008965063)
Registrant - Aveva Drug Delivery Systems (783982093)
Establishment
NameAddressID/FEIOperations
Aveva Drug Delivery Systems783982093manufacture(0363-8001, 0363-8000, 0363-8002), analysis(0363-8001, 0363-8000, 0363-8002)

 
Walgreens

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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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