FDA Label for Quit Smoking Proven Patches
View Indications, Usage & Precautions
Quit Smoking Proven Patches Product Label
The following document was submitted to the FDA by the labeler of this product Jiashen International Trade Limited. 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.
Otc - Active Ingredient
Nicotine
Otc - Purpose
Stop smoking aid
Otc - When Using
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Warnings
If you are pregnant or breast-feeding, only use this medicine on the advice of your healthcare provider.Smoking can seriously harm your child.Try to stop smoking without using any nicotine replacement medicine.This medicine is believed to safer than smoking.However, the risks to your child from this medicine are not full known.
Otc - Ask Doctor
Ask a doctor or pharmacist before use ifyou are"usinga non-nicotine stop smoking drugtaking a prescription medicine for depression or asthma.Your prescription dose may need to be adjusted.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets.
Used patches have enough nicotine to poison children and pets.If swallowed, get medical help or contact a Poison Control Center right away.Save pouch to use for patch di posal.Dispose of the used patches by folding sticky ends together and putting in pouch.
Indications & Usage
Uses reduces withdrawal symptoms,includingnicotine craving,associated with quittingsmoking
*ifyou smoke 10 orless cigarettes per day, do not useSTEP 1 (21 mg). Start with STEP 2 (14 mg) for 6 weeks,then STEP 3 (7 mg) for 2 weeks and then stop.steps 2 and 3 allow you to gradually reduce yourlevel ofnicotine.Completingthe full program willincrease yourchances ofquittingsuccessfully.apply one new patch every 24 hours on skin that is dry, cleanand hairless. Save pouch for disposingofthe patch after use.remove backingfrom patch andimmediately press onto skin.Hold for 10 seconds.
Dosage & Administration
STEP1
Use one 21 mgpatch/day
Weeks 1-6
STEP 2
Use one 14 mg
patch/day
Weeks 7-8
STEP 3
Use one7mg
patch/day
Weeks9-10
Inactive Ingredient
Inactive ingredientsethylene vinylacetate-copolymer, polyisobutylene and high densitypolyethylene between clearpolyester backings
Package Label.Principal Display Panel
* Please review the disclaimer below.
