Otc - Active Ingredient
Active ingredient - Laburnum anagyroides 1x
Tbx-free
FDA Label NDC 72041-001
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 Holyone Bio-technologyco Ltd for the product Tbx-free (NDC 72041-001). 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, dosage & administration, warnings, otc - keep out of reach of children, indications & usage, 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
PURPOSE
Homeopathic treatment of chronic nicothism
Dosage & Administration
Directions and Use
- For adults 18 years or older
- For best results use TBX-FREE on your quit day
- It is important to complete treatment. If you feel you need to use TBX-FREE for a longer period to keep from smoking, talk to your health care provider.
- Reduce nicotine cravings associated with smoking cessation
- If you smoke over 20 cigarettes a day, take 4 strips a day as needed
- If you smoke under 20 cigarettes a day, use TBX-FREE as recommended below.
Warnings
Do not use: In conjunction with another smoking cessation product; if you are taking prescription medication for depression or asthma; 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 doctor of pharmacist before use if you have: heart disease or an irregular hearbeat; high blood pressure; stomach ulcers; diabetes; allergies to other medications
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.
If pregnant or breast feeding, ask a health professional before use
Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
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
Smoking cessation treatment
Inactive Ingredient
INACTIVE INGREDIENTS
Licorice, menthol, natural mint extract, pullulan, sucralose, sugar
* Please review the disclaimer below.
