Otc - Active Ingredient
Nicotine 14 mg
The following Structured Product Label (SPL) was submitted to the FDA by Guangxi Keyun E-commerce Co., Ltd. for the product Nicotine Stop Smoking Aid Step2 (NDC 87278-018). 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 14 mg
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 believedto 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.
N:cotine 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 dlabetes.
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.
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.
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 diroctions 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
Step2
Use one 14 mg patch/day
Weeks 7-8
Step3
Use one 7 mg patch/day
· If you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then step 3for 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 moming.
· To avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging procedures.
· 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.
2-Hydroxyethyl Acrylate
Powdered Cellulose
Methacrylic Acid
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