FDA Label for Quit Smoking 21mg
View Indications, Usage & Precautions
Quit Smoking 21mg Product Label
The following document was submitted to the FDA by the labeler of this product Shenzhen Hengdasheng Technology Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Nicotine, 21 mg delivered over 24 hours
Purpose
Stop smoking aid
Use
Use reduces withdrawal symptoms, including nicotine craving,associated with quitting smoking
Warnings
If you are pregnant or breast-feeding, only use thismedicine on the advice of your health care provider.
Smoking can seriously harm your child. Try to stop smokingwithout 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.
Do Not Use
* 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
* using a non-nicotine stop smoking drug
* taking a prescription medicine for depression or asthma.
Your prescription dose may need to be adjusted.
Otc - When Using
If you have vivid dreams or other sleep disturbances, remove this patch at bedtime
Otc - Stop Use
Skin redness caused by the patch does not go away after four days,
or ifyour skin swells, oryou get a rash.irregular heartbeat or palpitations
occuryou 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)
Otc - Keep Out Of Reach Of Children
Used patches have enough nicotine to poison children and pets.if swallowed.
get medical help or contact a Poison Control Center right away.Dispose of the
used patches by folding sticky ends together. Replace in pouch and discard.
Directions
If you are under 18 years of age, ask a doctor before use. If you smoke more than 10
cigarettes per day, use the following schedule below:
STEP1:Use one 21 mg patch/day---Weeks 1-4
STEP2:Use one 14 mg patch/day---Weeks 5-6
STEP3:Use one 7 mg patch/day---Weeks 7-8
* if you smoke 10 or less cigaretttes per day, start with Step2 for6 weeks, then Step 3 for 2 weeks.
* remove backing from patch and immediately press onto skin.Hold for 10 seconds wash hands
after applying or removingpatch.Throw away the patch by folding sticky ends together.Replace in its pouch and discard.
* you may wear the patch for 16 or 24 hours
* ifyou crave cigarettes when you wake up. wear the patch for 24 hours
* if you have vivid dreams or other sleep disturbances, you mayremove the patch at bedtime
and apply a new one in the morning
* the used patch should be removed and a new one applied to a different skin site at the same time each day
*Avoid wearing the patch on the same area more than once a week.*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.
Other Information
store at 20-25°C(68-77°F)
Inactive Ingredients
ethylene/vinyl acetate copolymer, polyethylene(high density),polyisobutylene(pib), borneol.
Package Label - Principal Display Panel
* Please review the disclaimer below.
