Nicotine description, usages, side effects, indications, overdosage, supplying and lots more!

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Nicotine

Sam's West Inc
Sanofi-Aventis U.S. LLC

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Nicotine, 21 mg delivered over 24 hours

Stop smoking aid

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

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, or use a nicotine gum 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.
  • •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. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.

  • If you are under 18 years of age, ask a doctor before use
  • •before using this product, read the enclosed User’s 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 according to the following 10 week schedule:
STEP 1STEP 2STEP 3Use one 21 mg patch/dayUse one 14 mg patch/dayUse one 7mg patch/dayWeeks 1-6Weeks 7-8Weeks 9-10
 
 
 
 
 
 
 
 
 

store at 20-25°C (68-77°F)

ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings

call toll-free 1-866-255-5205 (English/Spanish) weekdays

TO INCREASE YOUR SUCCESS IN QUITTING:

  • 1.You must be motivated to quit.
  • 2.Complete the full treatment program, applying a new patch every day.
  • 3.Use with a support program as described in the enclosed User’s Guide.
  •   For your family’s protection, Nicotine Patches are supplied in child-resistant pouches. Do not use if individual pouch/packet is damaged or open.
  •  Nicotine transdermal system 21 mg delivered over 24 hours
  •   Stop smoking aid
  • •Not for sale to those under 18 years of age.
  • •Prrof of age required.
  • •Not for sale in vending machines or from any source where proof of age cannot be verified
  •  Free Audio CD upon request. See inside.
  •   What is the Nicotine Patch and How is it Used?
  •  Nicotine Patch is a small, nicotine-containing patch. When you put on a Nicotine Patch nicotine passes through the skin and into your body. Nicotine Patch is very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 24 or 16-hour period you wear the Nicotine Patch. This helps to reduce cravings you may have for nicotine.
  •  Read carton and enclosed User’s Guide before using this product. Keep the carton and User’s Guide. They contain important information.
  •  THE SIMPLY RIGHT™ PROMISE
  •  Simply Right is dedicated to providing healthful, gentle, and safe personal care products for the entire family. We continuously strive to be your trusted partner in wellness and exceed your expectations.
  •  We would like to hear from you with any comments or suggestions. In the continental US or Canada, you can call us toll-free at 1-800-255-5205, Monday through Friday, from 8 am to 5 pm CST. Or you can send us an email at samsclub.com.
  •  Distributed by:
  •  SAM’S West, Inc.
  •  Bentonville, AR 72716
  •  *NICODERM is a licensed trademark of the GlaxoSmithKline group of companies.
  •  SATISFACTION GUARENTEED BY REFUND OR EXCHANGE
  •  Made in Switzerland
  •   Send comments/questions to:
  •   GCSP 5.4376.4C
  •   Consumer Relations
  •   P.O. Box 13398
  •   Research Triangle Park, NC 27709-9627

Principal Display Panel

NDC 68196-194-03

nicotine patch

Nicotine Transdermal System 21mg delivered over 24 hours Stop smoking aid

Compare to NicoDerm®CQ® *

SIMPLY RIGHT

Health Care

Includes behavior support program enrollment form & user’s guide

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

21 mg

step 1

21 clear patches

©2011

101775XA

Nicotine

nicotine PATCH, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68196-194
Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 21 mg

Inactive Ingredients

Ingredient Name Strength
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)
HIGH DENSITY POLYETHYLENE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 PATCH
2 NDC:68196-194-03 21 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020165 2012-03-02


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