Drug Facts

Drug Facts
SPL v12
SPL
SPL Set ID 051be7ae-6504-c2d8-7424-2e328e4fcfc2
Route
TRANSDERMAL
Published
Effective Date 2016-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (21 mg)
Inactive Ingredients
Methacrylic Acid

Identifiers & Packaging

Marketing Status
NDA Active Since 2018-07-13

Description

Nicotine, 21 mg delivered over 24 hours

Purpose

Stop smoking aid


Medication Information

Purpose

Stop smoking aid

Description

Nicotine, 21 mg delivered over 24 hours

Use

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

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:
  • 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.
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.

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.
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)

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.

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)

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)

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.

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.

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

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.


Structured Label Content

Use

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Purpose

Stop smoking aid

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:
  • 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.
Warnings Section (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.

Other Information (Other information)

store at 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (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.
When Using This Product (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 (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)

Principal Display Panel Step 1 (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.

Principal Display Panel Step 2 (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)

Principal Display Panel Step 3 (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)

Ask A Doctor Before Use If You Have (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.

Keep Out of Reach of Children and Pets (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.

Active Ingredient Step 1 (in Each Patch) (Active ingredient Step 1 (in each patch))

Nicotine, 21 mg delivered over 24 hours

Active Ingredient Step 2 (in Each Patch) (Active ingredient Step 2 (in each patch))

Nicotine, 14 mg delivered over 24 hours

Active Ingredient Step 3 (in Each Patch) (Active ingredient Step 3 (in each patch))

Nicotine, 7 mg delivered over 24 hours

Ask A Doctor Or Pharmacist Before Use If You Are (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.


Advanced Ingredient Data


Raw Label Data

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