Otc - Active Ingredient
nicotine
The following Structured Product Label (SPL) was submitted to the FDA by Henan Jiugao Cross-border Ecommerce Co., Ltd. for the product Quit Smoking Patches (NDC 87135-001). 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 - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
nicotine
Stop smoking aid
Use reduces withdrawal symptoms, includingnicotine craving, associated with quittingsmoking
lf you are pregnant or breast-feeding, only usethis medicine on the advice of your health careproviderSmoking can seriously harm your child, Try tostop smoking without using any nicotinereplacement medicine This medicine is believedto be safer than smoking. However, the risks toyour child from this medicine are not fullyknown.
Ask a doctor before use if you havee
Heart disease, recent heart attack, or irregualr heartbeat, Nicotine can increase your heart rate.
High blood pressure not controlled withmedication, Nicotine
can increase your blood pressure.
An allergy to adhesive tape or have skinproblems, because you are more likely to get rashes.
Ask a doctor or pharmacist before use if you are:
Using a non-nicotine stop smoking rug taking a prescription medicine for depression or asthma.Your prescription dose may need to be adjusted
When using this product Stop use and ask a doctor if
if you have vivid dreams or other sleep disturbances remove this patch in bedtime
Keep out of reach of children and pets
Used patches have enough nicotine to poisonchildren and pets if swallowed, get medicalhelp or conlact a poison control center rightaway. Save pouch to use for patch disposal.Dispose o the used patches by foiding sticky ands together and putung in pouch.
Directions
lf you are under 18 years of age,ask a doctor before use
Before using this product, read the enclosedself-help guide for complete directions andother information
Begin using the patch on your quit dayIf you smoke more than 10 cigarettes perday,use the following schedule below
Weeks 1-4
step1 Use one 21 mgpatch / day
Weeks 5-6
step2 Use one 14 mg patch / day
Weeks 7-8
step3 Use one 7 mgpatch / day
lf you smoke 10 or less cigarettes per day,start with Step2 for 6 weeks, then step 3 for2 weeks Apply one new patch every 24 hourson skin that is dry,clean and hairless.Remove backing from patch andimmediately press onto skin, Hold for 10seconds.Wash hands after applying orremoving patch,Save pouch to use for patch disposal.Dispose of the used patches by folding stickyends together and putting in pouch.The used patch should be removed and anew one applied to a different skin site atthe same time each day.if you have vivid dreams, you may removethe patch at bedtime and apply a new one inthe morning.
Do not wear more than one patch at a time.Do not cut patch in half or into smailerpieces.Do not leave patch on for more than 24hours because it may imitate your skin andloses strength after 24 hours.To avoid p¶ssible burns, remove patchbefore undergoing any MRl (magneticresonance imaging)procedures.It is important to complete treatment, if youfeel youneed to use the patch for a longerperiod to keep from smoking, taik to yourhealth care provider.
methacrylic acid copolymer
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