NICOTINE TRANSDERMAL SYSTEM: Package Insert and Label Information

NICOTINE TRANSDERMAL SYSTEM- nicotine
Dr. Reddy’s Laboratories Inc.

Nicotine Patch Kit

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

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.

Do not use

if you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use another 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 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
stop smoking completely when you begin using the patch
if you smoke more than 10 cigarettes per day, use the following schedule below:

STEP 1

STEP 2

STEP 3

Use one 21mg patch/day

Use one 14mg patch/day

Use one 7mg patch/day

Weeks 1-4

Weeks 5-6

Weeks 7-8

if you smoke 10 or less cigarettes per day , start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stop
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
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, 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 Kit

Nicotine Transdermal System PATCH Kit

Nicotine Patch Kit
(click image for full-size original)
NICOTINE TRANSDERMAL SYSTEM
nicotine kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43598-445
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-445-28 56 PATCH in 1 CARTON contains a PATCH (43598-445-56)
1 NDC:43598-445-56 1 KIT in 1 PATCH This package is contained within the CARTON (43598-445-28)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1
Part 2 1
Part 3 1
Part 1 of 3
NICOTINE
nicotine transdermal system patch, extended release
Product Information
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nicotine (Nicotine) Nicotine 21 mg in 24 h
Inactive Ingredients
Ingredient Name Strength
Methacrylic Acid
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020076 05/14/2015
Part 2 of 3
NICOTINE
nicotine transdermal system patch, extended release
Product Information
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nicotine (Nicotine) Nicotine 14 mg in 24 h
Inactive Ingredients
Ingredient Name Strength
Methacrylic Acid
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020076 05/14/2015
Part 3 of 3
NICOTINE
nicotine transdermal system patch, extended release
Product Information
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nicotine (Nicotine) Nicotine 7 mg in 24 h
Inactive Ingredients
Ingredient Name Strength
Methacrylic Acid
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020076 05/14/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020076 05/14/2015
Labeler — Dr. Reddy’s Laboratories Inc. (802315887)

Revised: 01/2020 Dr. Reddy’s Laboratories Inc.

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