TBX-FREE- cytisine strip 
Dalian Jixin Electronic Information Co., Ltd.

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.

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Active Ingredient

Cytisine 8mg

Purpose
Treatment of chronic nicotinism

KEEP OUT OF REACH OF CHILDREN

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

Use
Smoking cessation treatment

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

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

TBX LABEL

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)

Revised: 11/2015
Document Id: 24fdfded-5d48-07a4-e054-00144ff8d46c
Set id: 24fdfded-5d47-07a4-e054-00144ff8d46c
Version: 2
Effective Time: 20151120
 
Dalian Jixin Electronic Information Co., Ltd.