FDA records indicate that there are no current recalls for this drug.
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Della One Plus Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
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- if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products
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- heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
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- high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
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- an allergy to adhesive tape or have skin problems because you are more likely to get rashes
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- using a non-nicotine stop smoking drug
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- taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.
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- do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch.
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- if you have vivid dreams or other sleep disturbances remove this patch at bedtime
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- skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash
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- irregular heartbeat or palpitations occur
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- you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness and rapid heartbeat
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.
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- if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products
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- 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.
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- an allergy to adhesive tape or have skin problems because you are more likely to get rashes
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- using a non-nicotine stop smoking drug
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- taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.
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- skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash
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- irregular heartbeat or palpitations occur
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- you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness and rapid heartbeat
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Della One Plus Manufacturers
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Delaval
Della One Plus | Walgreen Company
• if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User’s Guide for complete directions and other information • stop smoking completely when you begin using the patch • if you smoke more than 10 cigarettes per day, use according to the following 10 week schedule:STEP 1
STEP 2
STEP 3
Use one 21mg patch/day
Use one 14mg patch/day
Use one 7mg patch/day
Weeks 1-6
Weeks 7-8
Weeks 9-10
• if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg). Start with STEP 2 (14mg) for 6 weeks, then STEP 3 (7mg) for 2 weeks and then stop. • steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully. • apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use. • remove backing from patch and immediately press onto skin. Hold for 10 seconds. • wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User’s Guide for safety and handling. • you may wear the patch for 16 or 24 hours • if you crave cigarettes when you wake up, wear the patch for 24 hours • if you have vivid dreams or other sleep disturbances, you may remove 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 • 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 • stop using the patch at the end of 10 weeks. If you started with STEP 2, stop using the patch at the end of 8 weeks. If you still feel the need to use the patch, talk to your doctor.
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