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#

ProductTBX-Free
Active ingredientLABURNUM ANAGYROIDES FLOWERING TOP
Label structure9 sections

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 1-2Day 3-5Day 6-12Day 13-19Day 20-30Day 31 +
      Take 8 strips per dayTake 6 strips per dayTake 5 strips per dayTake 4 strips per dayTake 2 stips per dayTake 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

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69305-002-012020-01-31C16284748780-19d75b9d0-3d39-f424-e053-dadaa90a57ceTBX-Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69305-002-01TBX-Free120 [hp_X] in 1 BOXSTRIP1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69305-002TBX-FREE (LABURNUM ANAGYROIDES) STRIP [ADVANCED MEN’S INSTITUTE LLC]5Legacy NDC, 1 package rows20180119_322009fc-0379-6320-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69305-00269305-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
629b4c3c-9b62-2e80-e053-2991aa0aaaac322009fc-0379-6320-e054-00144ff8d46c2018-01-12WarningsExact identifier
spl id: 629b4c3c-9b62-2e80-e053-2991aa0aaaac
spl set id: 322009fc-0379-6320-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.