Label: NICOTINE patch

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 23, 2011

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  • SPL UNCLASSIFIED SECTION

    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

    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. If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider.

    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 4Weeks 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 start with for 6 weeks, then for 2 weeks and then stop less cigarettes per day,Step 2Step 3
    • 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

    Label Image
  • INGREDIENTS AND APPEARANCE
    NICOTINE 
    nicotine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64725-5895(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:64725-5895-114 h in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07461210/20/1997
    Labeler - TYA Pharmaceuticals (938389038)
    Registrant - TYA Pharmaceuticals (938389038)
    Establishment
    NameAddressID/FEIBusiness Operations
    TYA Pharmaceuticals938389038RELABEL(64725-5895) , REPACK(64725-5895)
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