FDA Label for Nicduic Quit Smoking Nicotine Patches
View Indications, Usage & Precautions
Nicduic Quit Smoking Nicotine Patches Product Label
The following document was submitted to the FDA by the labeler of this product Shenzhen Paxi Trading 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 28mg
Purpose
Stopsmoking aid
Use
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.
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 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 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 healthcare provider.
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.
Do Not Use
Ask a doctor or pharmacist before use:
- Contraindicated in heart disease, recent MI, or arrhythmia. Nicotine may increase heart rate.
- Uncontrolled hypertension. Nicotine may elevate blood pressure.
- If allergic to adhesive or with pre-existing skin conditions, higher risk of dermal reactions may occur.
- Stomach ulcer or diabetes.
- History of seizures.
Ask Doctor
Ask a doctor or pharmacist before use if you:
- are using non-nicotine smoking cessation drug .
- are taking prescription medications for depression or asthma, your dosage may require adjustment.
When Using
When using this product
- if you experience vivid dreams or other sleep disturbances, remove the patch at bedtime.
- Divide into four portions (7 mg each) before using for the first time. Non-smokers should not use this product.
Stop Use
Discontinue use and consult a physician if:
- Patch-induced erythema persists beyond 4 days,localized edema develops, or a cutaneous rash appears.
- irregular heartbeat or palpitations occur.
- Symptoms of nicotine overdose may include persistent nausea, vomiting, dizziness, weakness, and rapid heartbeat.
- You have symptoms of an allergic reaction (such as difficulty breathing or rash).
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN AND PETS.
Used patches contain enough nicotine to poison children and pets. If swallowed, seek medical help immediately or contact a Poison Control Center 1-800-222-1222 right away. Save the pouch for patch disposal. Dispose of used patches by folding the sticky ends together and placing them in the pouch.
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.
If you smoke more than 20 cigarettes per day, use the following schedule below:
Weeks 1 and 2
STEP 1+
use1½
patch/day
Weeks 3 and 6
STEP 1
use 1
patch/day
Weeks 7 and 8
STEP 2
use I/2
patch/day
Weeks 9 and 10
STEP 3
use I/4
patch/day
If you smoke more than 10 but not more than 20 cigarettes, start with Step 1, if you smoke 10 or less cigarettes per day, start with Step 2 for 4 weeks (Start with 1 patch or 3/4 patch for the first week), then on to Step 3 for 2 weeks. (Read the enclosed self–help guide for additional information.)
Apply one new patch every 24 hours on skin that is dry, clean and hairless.
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 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 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 healthcare provider.
Other Information
Store at room temperature
Inactive Ingredients
acrylate adhesive, aluminized polyester,cellulose paper, methacrylic acid copolymer.
Questions
After-sales service contact information:
For any product inquiries, contact us: [email protected]
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