TBX-Free
- Manufacturer
- Advanced Men’s Institute LLC | Dalian Jixin
- Effective date
- 2018-01-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 02:09:10
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
PURPOSE
Homeopathic treatment of chronic nicotinism
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN
Incase of overdose, get medical help or contact your poison control center right away
INDICATIONS & USAGE SECTION
Use
Smoking cessation treatment
DOSAGE & ADMINISTRATION SECTION
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 SECTION
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 SECTION
INACTIVE INGREDIENTS
Pullulan, Natural mint extract, Sugar, Menthol, Licorice, Sucralose
SPL UNCLASSIFIED SECTION
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 SECTION
ACTIVE INGREDIENT
Laburnum anagyroides 1X
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69305-002-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3d39-f424-e053-dadaa90a57ce | TBX-Free |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69305-002-01 | TBX-Free | 120 [hp_X] in 1 BOX | STRIP | 120 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- TBX-Free
- Laburnum anagyroides
- LABURNUM ANAGYROIDES FLOWERING TOP
- MINTLACTONE
- SUCROSE
- LICORICE
- PULLULAN
- MENTHOL, UNSPECIFIED FORM
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69305-002 | 69305-002-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LABURNUM ANAGYROIDES FLOWERING TOP | A3V9296222 | ACTIB |
| MINTLACTONE | X2T3I06CWR | IACT |
| SUCROSE | C151H8M554 | IACT |
| LICORICE | 61ZBX54883 | IACT |
| PULLULAN | 8ZQ0AYU1TT | IACT |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 629b4c3c-9b62-2e80-e053-2991aa0aaaac | 322009fc-0379-6320-e054-00144ff8d46c | 2018-01-12 | Warnings | 629b4c3c-9b62-2e80-e053-2991aa0aaaac 322009fc-0379-6320-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
