TBX-Free: Homeopathic Product Information

TBX-FREE- laburnum anagyroides flowering top strip
Advanced Men’s Institute LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

PURPOSE

Homeopathic treatment of chronic nicotinism

KEEP OUT OF REACH OF CHILDREN

Incase of overdose, get medical help or contact your poison control center right away

Use

Smoking cessation treatment

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

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 INGREDIENTS

Pullulan, Natural mint extract, Sugar, Menthol, Licorice, Sucralose

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

ACTIVE INGREDIENT

Laburnum anagyroides 1X

label
(click image for full-size original)

TBX-FREE
laburnum anagyroides strip
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69305-002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABURNUM ANAGYROIDES FLOWERING TOP (LABURNUM ANAGYROIDES FLOWERING TOP) LABURNUM ANAGYROIDES FLOWERING TOP 1 [hp_X] in 10 [hp_X]
Inactive Ingredients
Ingredient Name Strength
MINTLACTONE
SUCROSE
LICORICE
PULLULAN
MENTHOL, UNSPECIFIED FORM
SUCRALOSE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69305-002-01 120 [hp_X] in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 04/19/2016
Labeler — Advanced Men’s Institute LLC (079526408)
Establishment
Name Address ID/FEI Operations
Dalian Jixin 079526408 manufacture (69305-002)

Revised: 01/2018 Advanced Men’s Institute LLC

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