FDA Label for Rbugr Quit Smoking Nicotine
View Indications, Usage & Precautions
Rbugr Quit Smoking Nicotine Product Label
The following document was submitted to the FDA by the labeler of this product Jiangxi Hemei Pharmaceutical 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
Nicotine 18%
menthol 0.3%
Purpose
stop smoking aid
Use
reduces withdrawal symptoms,including nicotine craving,associated with quitting smoking
Warnings
If you are pregnant or breast-feeding, only use this patch on the advice of your health care provider.Smoking can seriously harm your child.
· Try to stop smoking without using any nicotine replacement patch,This patch is considered safer than smoking. However, the risks to your child from this patch are not fully known.
·The patch is effective in helping to alleviate nicotine cravings. lt is a health supplement to assist in quitting smoking and is not to be used in place of a nicotine patch.
Do Not Use
If you are allergic to any of the ingredients.
·Gastric ulcers or diabetes mellitus, history of seizures prohibited.
· lf you are under 18 years of age without a doctor's recommendation.
· Do not use on damaged skin or wounds.
When Using
if you have vivid dreams or other sleep disturbances, remove this patch at bedtime. · Stop use and ask a doctor if feeling uncomfortable or experiencing other sensitive dizziness symptoms. · And follow phase recommendations (being adjusted within the recommended range according to your condition and acceptability). · Do not cut the 7mg, patch into halves or smaller pieces, · To avoid possible burns,remove the patch before perfomming an MRl (Magnetic Resonance lmaging) examination. · Adjust the wearing time according to your body weight and your smoking needs (it is best to wear the patch for more than 12 hours in order to allow the nicotine in the patch to penetrate completely into the skin, and if you feel uncomfortable, you can use the intermittent patch method, i.e., temporarly remove the patch and put it back on once the discomfort subsides). · The used patch should be removed and a new one applied to a different skin site at the same time each day.·Slight dizziness and nausea during use are normal, please stop using temporarily and drink more water. · Reduce the dosage and use it again when it returns to norma. ·lt 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. · It is best to remove hair from the surface of the skin and keep the skin dry before use for best results. · Drink plenty of water during use of the patch to promote absorption and metabolism
Stop Use
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.・Skin redness caused by the patch does not go away after 4 days or ·You develop a rash, swelling, or severe skin irritation.・You experience irregular heartbeat or palpitations.・Symptoms of nicotine overdose occur (such as nausea, vomiting, dizziness, or weakness).・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.
Ask Doctor
Heart disease,recent heart attack, or irregular of heartbeat.·Cardiovascular disorders ·History of myocardial infarction Documented arrhythmias ·High blood pressure not controlled by medication,·Stomach ulcer or diabetes· Been prescribed medication for depression or asthma·Non-tobaccco users or people with skin allergies.
Keep Out Of Reach Of Children
Please store in a cool dry place for best results. (preferably under 20-25°). Keep out of reach of children and pets.Please wrap used patches completely before throwing them away. lf inadvertently licked by children or pets,get medical help or contact a Poison Control Center right away.
Directions
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.· lf you smoke more than 10 cigarettes per day, use the following schedule below.
If you smoke no more than ten cigarettes a day, please start with step 2. Keep your skin clean and dry before each use.lmmedlatehtne after removing teh adhesive backing.apply the patch to the skin and press teh patch against the skin for ten swconds to ewsure a snug fit. Wash your hands after each patch application and after removing the patch privately.
Inactive Ingredients
acrylate adhesive, cellulose paper, methacrylic acid .
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