HABITROL STEP 1 (NICOTINE TRANSDERMAL SYSTEM PATCH ) PATCH, EXTENDED RELEASE HABITROL STEP 2 (NICOTINE TRANSDERMAL SYSTEM PATCH ) PATCH, EXTENDED RELEASE HABITROL STEP 3 (NICOTINE TRANSDERMAL

HABITROL STEP 1 (NICOTINE TRANSDERMAL SYSTEM PATCH ) PATCH, EXTENDED RELEASE HABITROL STEP 2 (NICOTINE TRANSDERMAL SYSTEM PATCH ) PATCH, EXTENDED RELEASE HABITROL STEP 3 (NICOTINE TRANSDERMAL
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NDC 55741-446-70, 55741-446-74, 55741-447-70, 55741-447-74, 55741-448-28, 55741-448-70, 55741-448-74
Set ID 051be7ae-6504-c2d8-7424-2e328e4fcfc2
Category HUMAN OTC DRUG LABEL
Packager Dr. Reddy's Laboratories Inc.
Generic Name
Product Class
Product Number
Application Number NDA020076
  • 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 SECTION

    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 rashirregular 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:
    steps
    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 STEP 1

    NDC 55741-448-74

    Habitrol®
    Nicotine Transdermal System Patch

    21 mg delivered over 24 hours

    STOP SMOKING AID

    21 mg

    Includes:
    Behavior Support
    Program with

    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

    7 Patches
    (1 Week Kit)

    The full treatment course for Step 1 is 28
    patches (4 weeks); this package contains 7
    patches (1 week course) only. Read the enclosed
    self-help guide for additional information.

    21mg 7ct carton

  • Principal Display Panel STEP 2

    NDC 55741-447-74

    Habitrol® 

    Nicotine Transdermal System Patch

    14 mg delivered over 24 hours

    STOP SMOKING AID

    14 mg

    Includes:
    Behavior Support
    Program with

    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

    7 Patches
    (1 Week Kit)

    14mg 7ct carton

  • Principal Display Panel STEP 3

    NDC 55741-446-74

    Habitrol® Take Control™ Support Program
    Nicotine Transdermal System Patch

    7 mg delivered over 24 hours

    STOP SMOKING AID

    7 mg

    Includes:
    Behavior Support
    Program with

    self-help guide

    STEP 3

    FOR USE AFTER COMPLETING STEP 2

    7 Patches
    (1 Week Kit)

    7mg 7ct carton

  • INGREDIENTS AND APPEARANCE
    HABITROL   STEP 1
    nicotine transdermal system patch patch, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55741-448
    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
    Methacrylic Acid (UNII: 1CS02G8656)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55741-448-7414 in 1 CARTON06/15/2019
    124 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:55741-448-707 in 1 CARTON06/15/2019
    224 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:55741-448-2828 in 1 CARTON07/01/2019
    324 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02007607/13/2018
    HABITROL   STEP 2
    nicotine transdermal system patch patch, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55741-447
    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
    Methacrylic Acid (UNII: 1CS02G8656)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55741-447-7414 in 1 CARTON04/22/2019
    124 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:55741-447-707 in 1 CARTON07/01/2019
    224 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02007607/13/2018
    HABITROL   STEP 3
    nicotine transdermal system patch patch, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55741-446
    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
    Methacrylic Acid (UNII: 1CS02G8656)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55741-446-7414 in 1 CARTON06/15/2019
    124 h in 1 PATCH; Type 0: Not a Combination Product
    2NDC:55741-446-707 in 1 CARTON07/01/2019
    224 h in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02007607/13/2018
    Labeler - Dr. Reddy's Laboratories Inc. (802315887)

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