Label: TBX-FREE- cytisine strip
- NDC Code(s): 69461-001-01
- Packager: Dalian Jixin Electronic Information Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Updated November 20, 2015
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
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.Close
- INDICATIONS & USAGE
Smoking cessation treatment
- DOSAGE & ADMINISTRATION
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.Close
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
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
- INGREDIENTS AND APPEARANCE
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)