TBX-FREE- cytisine strip

TBX-Free by

Drug Labeling and Warnings

TBX-Free by is a Homeopathic medication manufactured, distributed, or labeled by Dalian Jixin Electronic Information Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Cytisine 8mg

PURPOSE

Purpose
Treatment of chronic nicotinism

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a poison control center right away.

INDICATIONS & USAGE

Use
Smoking cessation treatment

DOSAGE & ADMINISTRATION

DIRECTIONS

Adults 18 years or over

Begin using TBX-Free on your quit day

It is important to complete treatment. If you feel you need to use TBX-Free to keep from smoking, talk to your health care provider.

WARNINGS

Warnings
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)

INACTIVE INGREDIENT

Inactive Ingredients
pullulan, natural mint extract, sugar, menthol, licorice, aspartame

OTHER SAFETY INFORMATION

OTHER SAETY INFORMATION

Protect from excessiv moisture and heat

Store between 15º and 25º C (59º to 77 º F)

QUESTIONS OR COMMENTS

1-800-965-1594

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TBX-FREE 
cytisine strip

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69461-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYTISINE (UNII: 53S5U404NU) (CYTISINE - UNII:53S5U404NU)	CYTISINE	8 mg  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
MENTHOL (UNII: L7T10EIP3A)
LICORICE (UNII: 61ZBX54883)
PULLULAN (UNII: 8ZQ0AYU1TT)
MINT (UNII: FV98Z8GITP)
ASPARTAME (UNII: Z0H242BBR1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69461-001-01	110 mg in 1 BOX; Type 0: Not a Combination Product	11/20/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/20/2015

Labeler - Dalian Jixin Electronic Information Co., Ltd. (544903951)

Establishment
Name	Address	ID/FEI	Business Operations
Dalian Jixin Electronic Information Co., Ltd.		544903951	manufacture(69461-001)