Otc - Active Ingredient
NICOTINE 7mg
NICOTINE 14mg
NICOTINE 21mg
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Yunzhen Trading Co., Ltd. for the product Nicotine Patch (NDC 87704-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, indications & usage, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
NICOTINE 7mg
NICOTINE 14mg
NICOTINE 21mg
quit smoking
If pregnant or breastfeeding, use only on advice of healthcare provider.
Smoking seriously harms your child. Try to quit without nicotine replacement if possible. This medicine is believed safer than smoking, but risks to your child are not fully known.
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.
If pregnant or breastfeeding, use only on advice of healthcare provider.
Smoking seriously harms your child. Try to quit without nicotine replacement if possible. This medicine is believed safer than smoking, but risks to your child 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 the patch at bedtime
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 beartbeat.
you have symptoms of an allergic reaction (suchas difficulty breathing or rash).
Used patches contain enough nicotine to poison children or pets. If swallowed, get medical help or contact Poison Control immediately. Dispose by folding sticky ends together and placing in pouch.
If you are under 18 years of age, ask a doctor beforeuse
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 STEP 1:use one 21 mg patch/day
Weeks 5 and 6 STEP 2:use one 14 mg patch/day
Weeks 7 and 8 STEP 3:use one 7 mg patch/day
· If you smoke <10 cigarettes/day: start with Step 2 for 6 weeks, then Step 3 for 2 weeks.·
Under 18: ask a doctor before use.·
Apply one new patch every 24 hours to dry, clean,hairless skin.
Remove backing, press onto skin for 10 seconds.
Wash hands after handling. Dispose of used patches by folding sticky ends together and placing in original pouch.
Remove old patch and apply new one to a different skin site at the same time each day.
If vivid dreams occur, remove patch at bedtime and apply new one in the morning
Do not cut patch. Do not wear more than one patchat a time.·
Do not leave on longer than 24 hours (may irritateskin and loses strength).
Remove patch before MRI procedures to avoid burns.·
Complete treatment. If you need to use longer to stay smoke-free, talk to your healthcare provider.
Acrylate adhesive
Aluminized polyester
Cellulose paper
Methacrylic acid copolymer
* Please review the disclaimer below.