Otc - Active Ingredient
nicotine
Sefudun Quit Smoking Nicotine Patches
FDA Label NDC 83804-107
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Shandian Jingling Technology Co., Ltd. for the product Sefudun Quit Smoking Nicotine Patches (NDC 83804-107). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Stop smoking aid
Otc - Keep Out Of Reach Of Children
Used patches have enough nicotine to poison children and petsif swallowed, get medical help or conlact a poison control centerfight away, Save pouch to use for patch disposal. Dispose af theused patches by folding sticky ends together and putting in pouch,
Indications & Usage
Use reduices withdrawal symploms, including nicotine cravingassociated with guitting smokind
Warnings
if you are precnant or breast.feeding, only use this medicine onthe advice of your heaith care provider.Smoking can seribusly harm your child. Try to stop smoking withoutusing anvnicotine replacement medicine, This medicine is believedto be safer than smoking. However, the risks to your child from thismedicine are not fully known
Dosage & Administration
if you are under 18 years of age, ask a doctor before use. Before usino this product, read the enclosed self-help guide forcomplete directions and other infolmation.
Begin usio the patch on your quit day.
if you smoke more than 10 cigarettes per day, use the foilowingschedule below:
Weeks 1-4
Step 1
Use one 21 mgpatch / day
Weeks 5-6
Step 2
Use one 14 mgpatch / day
Weeks 7-8
Step 3
Use one 7 mgpatch day
Inactive Ingredient
methacrylic acid copolymer
POLYESTER-5 (TG-38)
ACRYLIC ACID
Package Label.Principal Display Panel
Label2 (Label2)
Label1 (Label1)
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