NICOTINE TRANSDERMAL SYSTEM patch, extended release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Nicotine (UNII: 6M3C89ZY6R) (Nicotine - UNII:6M3C89ZY6R)
Available from:
AmerisourceBergen Drug Corporation
INN (International Name):
Nicotine
Composition:
Nicotine 14 mg in 24 h
Administration route:
TRANSDERMAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stop smoking aid reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.
Authorization status:
Abbreviated New Drug Application
Authorization number:
46122-352-74, 46122-353-74, 46122-354-74, 46122-568-03, 46122-568-07

NICOTINE TRANSDERMAL SYSTEM- nicotine transdermal system patch, extended release

AmerisourceBergen Drug Corporation

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Nicotine Transdermal System - nicotine patch, extended release

Drug Fact

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 you smoke more than 10 cigarettes per day, use the following schedule below:

Weeks 1 thru 4

Weeks 5 and 6

Weeks 7 and 8

Step 1

Step 2

Step 3

Use one 21 mg

patch/day

Use one 14 mg

patch/day

Use 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

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. 46122-352-74

14 Patches

PRINCIPAL DISPLAY PANEL - 7 mg CARTON

Nicotine Transdermal System

NDC No. 46122-354-74

14 Patches

PRINCIPAL DISPLAY PANEL- 21 mg CARTON

Nicotine Transdermal System

NDC No. 46122-353-74

14 Patches

PRINCIPAL DISPLAY PANEL- 21 mg CARTON

Nicotine Transdermal System

NDC No. 46122-568-07

7 Patches

NICOTINE TRANSDERMAL SYSTEM

nicotine transdermal system patch, extended release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:46 122-352

Route of Administration

TRANSDERMAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Nico tine (UNII: 6 M3C8 9 ZY6 R) (Nico tine - UNII:6 M3C8 9 ZY6 R)

Nic o tine

14 mg in 24 h

Inactive Ingredients

Ingredient Name

Stre ng th

Dimethico ne (UNII: 9 2RU3N3Y1O)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:46 122-352-74

14 in 1 CARTON

0 7/20 /20 16

1

1 h in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 746 12

0 7/20 /20 16

NICOTINE TRANSDERMAL SYSTEM

nicotine transdermal system patch, extended release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:46 122-354

Route of Administration

TRANSDERMAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Nico tine (UNII: 6 M3C8 9 ZY6 R) (Nico tine - UNII:6 M3C8 9 ZY6 R)

Nic o tine

7 mg in 24 h

Inactive Ingredients

Ingredient Name

Stre ng th

Dimethico ne (UNII: 9 2RU3N3Y1O)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:46 122-354-74

14 in 1 CARTON

0 7/20 /20 16

1

1 h in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 746 12

0 7/20 /20 16

NICOTINE TRANSDERMAL SYSTEM

nicotine transdermal system patch, extended release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:46 122-353

Route of Administration

TRANSDERMAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Nico tine (UNII: 6 M3C8 9 ZY6 R) (Nico tine - UNII:6 M3C8 9 ZY6 R)

Nic o tine

21 mg in 24 h

Inactive Ingredients

Ingredient Name

Stre ng th

Dimethico ne (UNII: 9 2RU3N3Y1O)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:46 122-353-74

14 in 1 CARTON

0 7/20 /20 16

1

1 h in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 746 12

0 7/20 /20 16

NICOTINE TRANSDERMAL SYSTEM

nicotine transdermal system patch, extended release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:46 122-56 8

Route of Administration

TRANSDERMAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Nico tine (UNII: 6 M3C8 9 ZY6 R) (Nico tine - UNII:6 M3C8 9 ZY6 R)

Nic o tine

21 mg in 24 h

Inactive Ingredients

Ingredient Name

Stre ng th

Dimethico ne (UNII: 9 2RU3N3Y1O)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:46 122-56 8 -0 7

7 in 1 CARTON

0 4/0 2/20 19

1

1 h in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:46 122-56 8 -0 3

28 in 1 CARTON

0 5/26 /20 20

AmerisourceBergen Drug Corporation

2

1 h in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 746 12

0 4/0 2/20 19

Labeler -

AmerisourceBergen Drug Corporation (007914906)

Registrant -

Aveva Drug Delivery Systems (783982093)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Aveva Drug Delivery

Syste ms

78 39 8 20 9 3

analysis(46 122-352, 46 122-354, 46 122-353, 46 122-56 8 ) , manufacture(46 122-352,

46 122-354, 46 122-353, 46 122-56 8 )

Revised: 5/2020

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