Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Jiangxi Hemei Pharmaceutical Co., Ltd
Jiangxi Hemei Pharmaceutical Co., Ltd
724892056
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FIobow QUIT SMOKING Nicotine
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Use
reduces withdrawal symptoms,including nicotine craving,associated with quitting smoking
DOSAGE & ADMINISTRATION SECTION
Directions
If you are under 18 years of age, ask adoctor before use.
Before using this product,need 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. 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 removethe 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 MRl (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. Signs of excessive use may include nausea.vomiting,dizziness,weakness, or rapid heartbeat.lf these symptoms occur,remove the patch immediately and contact a doctor or poison control center
WARNINGS SECTION
Warnings
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
STORAGE AND HANDLING SECTION
Other information
store at 20-25°C
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Nicotine 18%
menthol 0.3%
OTC - PURPOSE SECTION
Purpose
stop smoking aid
OTC - ASK DOCTOR SECTION
Ask Doctor
Ask a doctor before use if you have
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.
Ask a doctor or pharmacist before use if 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep Out Of Reach Of Children
Keep out ofreach of children and pets.
OTC - DO NOT USE SECTION
Do not use
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 MRl (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.
OTC - STOP USE SECTION
Stop Use
Stop use and ask a doctor if Feeling uncomfortable or experiencing or other sensitive dizziness symptoms
OTC - WHEN USING SECTION
When Using
if you have vivid dreams or other sleep disturbances remove this patch at bedtime
INACTIVE INGREDIENT SECTION
Inactive ingredients
acrylate adhesive,cellulose paper,methacrylic acid