Otc - Active Ingredient
Active Ingredient
Cytisine 8mg
Tbx-free
FDA Label NDC 69461-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dalian Jixin Electronic Information Co., Ltd. for the product Tbx-free (NDC 69461-001). 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, dosage & administration, warnings, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Treatment of chronic nicotinism
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
In case of overdose, get medical help or contact a poison control center right away.
Indications & Usage
Use
Smoking cessation treatment
Dosage & Administration
DIRECTIONS
Adults 18 years or over
Begin using TBX-Free on your quit day
It is important to complete treatment. If you feel you need to use TBX-Free to keep from smoking, talk to your health care provider.
Warnings
Warnings
Do not use: in conjunction with another smoking cessation product; if you are taking prescription medication for depression or asthma; if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor or pharmacist before use if you have: heart disease or an irregular heartbeat; high blood pressure; stomach ulcers; diabetes; allergies to other medication
Stop use and speak to a doctor if any of the following occur: mouth, teeth, or jaw problems, irregular heartbeat or palpitations; you develop symptoms of an allergic reaction (such as difficulty breathing or a rash)
Inactive Ingredient
Inactive Ingredients
pullulan, natural mint extract, sugar, menthol, licorice, aspartame
Other Safety Information
OTHER SAETY INFORMATION
Protect from excessiv moisture and heat
Store between 15° and 25° C (59° to 77 ° F)
QUESTIONS OR COMMENTS
1-800-965-1594
Package Label.Principal Display Panel
Tbx Label (Label)
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