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  5. Label Information: Nicotine Transdermal System

FDA Label for Nicotine Transdermal System

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH PATCH)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN AND PETS.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. COMMENTS OR QUESTIONS?
    14. TO INCREASE YOUR SUCCESS IN QUITTING:
    15. PRINCIPAL DISPLAY PANEL - 14 MG CARTON
    16. PRINCIPAL DISPLAY PANEL - 7 MG CARTON
    17. PRINCIPAL DISPLAY PANEL- 21 MG CARTON

Nicotine Transdermal System Product Label

The following document was submitted to the FDA by the labeler of this product Apotex Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.
  • 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 yousmoke 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. 60505-7089-0

14 Patches

14mgcarton.jpg - 14mgcarton

14mgcarton.jpg - 14mgcarton


Principal Display Panel - 7 Mg Carton



Nicotine Transdermal System

NDC No. 60505-7088-0

14 Patches

7mgcarton.jpg - 7mgcarton

7mgcarton.jpg - 7mgcarton


Principal Display Panel- 21 Mg Carton



Nicotine Transdermal System

NDC No. 60505-7090-0

14 Patches

21mgcarton.jpg - 21mgcarton

21mgcarton.jpg - 21mgcarton


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