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Nicotine by Clinical Solutions Wholesale

Dosage form: patch
Ingredients: Nicotine 21mg in 24h
Labeler: Clinical Solutions Wholesale
NDC Code: 58118-9842

Drug Facts

Active ingredient (in each patch)

Nicotine, 21 mg delivered over 24 hours

Purpose

Stop smoking aid

Uses

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 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 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 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 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 used patch 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:

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 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 used patch 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
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, polyester, silicone adhesive

Comments or questions?

Call-1-877-440-7867 8 AM - 8PM ET, Monday-Friday

This product is not affiliated with Novartis Consumer Health, Inc.

Principal Display Panel - Step 1 – 21 mg Carton Label

Rugby®

NDC 0536-5896-88

COMPARE TO THE ACTIVE INGREDIENT IN HABITROL®*

Clear

Nicotine

Transdermal System

21 mg delivered over 24 hours

STOP SMOKING AID

21 mg

Includes Behavior Support Program with Self-Help Guide

Free Audio CD upon request.

STEP ONE

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

14 Patches

*Habitrol® is a registered trademark of Novartis Consumer Health, Inc.

NICOTINE 
nicotine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58118-9842(NDC:0536-5896)
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Nicotine (Nicotine) Nicotine21 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
dimethicone 
Packaging
#Item CodePackage Description
1NDC:58118-9842-414 POUCH in 1 CARTON
1NDC:58118-9842-11 PATCH in 1 POUCH
124 h in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461210/20/1997
Labeler - Clinical Solutions Wholesale (078710347)
Registrant - Clinical Solutions Wholesale (078710347)
Establishment
NameAddressID/FEIOperations
Clinical Solutions Wholesale078710347RELABEL(58118-9842)

 
Clinical Solutions Wholesale

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Medically reviewed on Dec 3, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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