Otc - Purpose
PURPOSE
Homeopathic treatment of chronic nicotinism
Tbx-free
FDA Label NDC 69305-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Men�s Institute Llc for the product Tbx-free (NDC 69305-002). 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 - purpose, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, inactive ingredient, other, otc - active ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Incase of overdose, get medical help or contact your poison control center right away
Indications & Usage
Use
Smoking cessation treatment
Dosage & Administration
DIRECTIONS
•Adults 18 years or older
•Begin using 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:
Day 1-2 Day 3-5 Day 6-12 Day 13-19 Day 20-30 Day 31 + Take 8 strips per day Take 6 strips per day Take 5 strips per day Take 4 strips per day Take 2 stips per day Take 1-4 strips per day as needed It is important to complete treatment: most will see best result after using TBX-FREE for 60-90 days
Warnings
WARNING
- 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)
- If pregnant or breast feeing, 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.
Inactive Ingredient
INACTIVE INGREDIENTS
Pullulan, Natural mint extract, Sugar, Menthol, Licorice, Sucralose
Other
OTHER INFORMATION
•protect from excessive moisture and heat
•store between 15° to 25° C (59° to 77° F)
- Do not use if tamper-evident seal is broken
- Phenylketonurics: Contains Phenylalanine .22 mg Per Strip
QUESTIONS OR COMMENTS?
1-800-404-4686
Otc - Active Ingredient
ACTIVE INGREDIENT
Laburnum anagyroides 1X
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