Otc - Active Ingredient
Nicotine, 7mg
Nicotine, 14mg
Nicotine, 21mg
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Shandian Jingling Technology Co., Ltd. for the product Sefudun Quit Smoking Nicotine Patches (21mg) (NDC 83804-021). 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, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Nicotine, 7mg
Nicotine, 14mg
Nicotine, 21mg
Stop smoking aid
Use 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.
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 wkin problems, because
you are more likely to get rashes.
Stomach ulcer or diabetes.
History of seizures
Using a non-nicotine stop smoking rug.
Taking a prescription medicine for depression or asthma
Your prescription dose may need to be adjusted.
If you have vivid dreams or other sleep disturbances remove this 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 heartbeat.
you have symptoms of an allergic reaction (such as difficulty breathing or rash)
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 1-4 Step1 Use one 21 mg patch/day
Weeks 5-6 Step 2 Use one 14 mg patch/day
Weeks 7-8 Step3 Use one7 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.
To avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures.
It is important to complete treatment. If you feel youneed to use the patch for a longer period to keep from smoking,talk to your health care provider.
acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer.
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