NDC 11822-1603 Nicotine Transdermal System
What is NDC 11822-1603?
The NDC code 11822-1603 is assigned by the FDA to the UNFINISHED product Nicotine Transdermal System which is a human over the counter drug product labeled by Rite Aid Corporation. The product's dosage form is kit and is administered via transdermal form. The product is distributed in a single package with assigned NDC code 11822-1603-1 1 kit in 1 carton * 1 patch, extended release in 1 pouch (11822-1601-0) * 1 patch, extended release in 1 pouch (11822-1600-0) * 1 patch, extended release in 1 pouch (11822-1602-0). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Nicotine Transdermal System?
This product is used as Stop smoking aid
NDC Code 11822-1603-1
Package Description: 1 KIT in 1 CARTON * 1 PATCH, EXTENDED RELEASE in 1 POUCH (11822-1601-0) * 1 PATCH, EXTENDED RELEASE in 1 POUCH (11822-1600-0) * 1 PATCH, EXTENDED RELEASE in 1 POUCH (11822-1602-0)
Nicotine Transdermal System Active Ingredients UNII Codes
- NICOTINE (UNII: 6M3C89ZY6R)
- NICOTINE (UNII: 6M3C89ZY6R) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 198029 - nicotine 14 MG/Day 24HR Transdermal System
- RxCUI: 198029 - 24 HR nicotine 0.583 MG/HR Transdermal System
- RxCUI: 198029 - nicotine 0.583 MG/HR 24HR Transdermal Patch
- RxCUI: 198029 - nicotine 14 MG per 24HR 1 Day Transdermal Patch
- RxCUI: 198030 - nicotine 21 MG/Day 24HR Transdermal System
Nicotine Transdermal System Inactive Ingredients UNII Codes
- DIMETHICONE (UNII: 92RU3N3Y1O)
* Please review the disclaimer below.
Nicotine Transdermal System Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- ACTIVE INGREDIENT (IN EACH PATCH)
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN AND PETS.
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- COMMENTS OR QUESTIONS?
- TO INCREASE YOUR SUCCESS IN QUITTING:
- PRINCIPAL DISPLAY PANEL-56 COUNT CARTON
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
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.
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.
- 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 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
- 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.
store at 20° C – 25° C (68° F – 77° F)
acrylate adhesive, polyester, silicone adhesive
Comments Or Questions?
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-56 Count Carton
Nicotine Transdermal System
NDC No. 11822-
* Please review the disclaimer below.