HABITROL PATCH NICOTINE TRANSDERMAL SYSTEM, STEP 1- nicotine patch, extended release 
.GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Drug Facts

Active ingredient

Nicotine, 21mg delivered over 24 hours

Purpose

Stop smoking aid

Uses

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 a 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 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:
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
 Steps 1, 2, 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 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)

18 YO Warning

Inactive ingredients

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

Comments or Questions?

Call 1-800-585-8682

Distributed by:

CVS Pharmacy

One CVS Drive

Woonsocket, RI 02895

Principal Display Panel

Step 1, 21mg

Step 1, 21 mg

HABITROL PATCH  NICOTINE TRANSDERMAL SYSTEM, STEP 1
nicotine patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-4870
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:0067-4870-1414 in 1 CARTON02/26/200308/01/2015
11 in 1 POUCH
124 h in 1 PATCH; Type 0: Not a Combination Product
2NDC:0067-4870-077 in 1 CARTON02/26/200308/01/2015
21 in 1 POUCH
224 h in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02007602/26/200308/01/2015
Labeler - .GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 12/2016
 
.GlaxoSmithKline Consumer Healthcare Holdings (US) LLC