TBX-FREE- laburnum anagyroides strip

TBX-Free by

Drug Labeling and Warnings

TBX-Free by is a Homeopathic medication manufactured, distributed, or labeled by Advanced Men’s Institute LLC, Dalian Jixin. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

PURPOSE

Homeopathic treatment of chronic nicotinism

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

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

ACTIVE INGREDIENT

ACTIVE INGREDIENT

Laburnum anagyroides 1X

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TBX-FREE 
laburnum anagyroides strip

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69305-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LABURNUM ANAGYROIDES FLOWERING TOP (UNII: A3V9296222) (LABURNUM ANAGYROIDES FLOWERING TOP - UNII:A3V9296222)	LABURNUM ANAGYROIDES FLOWERING TOP	1 [hp_X]  in 10 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
MINTLACTONE (UNII: X2T3I06CWR)
SUCROSE (UNII: C151H8M554)
LICORICE (UNII: 61ZBX54883)
PULLULAN (UNII: 8ZQ0AYU1TT)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69305-002-01	120 [hp_X] in 1 BOX; Type 0: Not a Combination Product	04/19/2016

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	Business Operations
Dalian Jixin		079526408	manufacture(69305-002)