Label: TBX-FREE- cytisine strip

  • 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.

Drug Label Information

Updated November 20, 2015

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  • 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

    TBX LABEL

  • INGREDIENTS AND APPEARANCE
    TBX-FREE 
    cytisine strip
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69461-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYTISINE (UNII: 53S5U404NU) (CYTISINE - UNII:53S5U404NU) CYTISINE8 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    MENTHOL (UNII: L7T10EIP3A)  
    LICORICE (UNII: 61ZBX54883)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    MINT (UNII: FV98Z8GITP)  
    ASPARTAME (UNII: Z0H242BBR1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69461-001-01110 mg in 1 BOX; Type 0: Not a Combination Product11/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/20/2015
    Labeler - Dalian Jixin Electronic Information Co., Ltd. (544903951)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalian Jixin Electronic Information Co., Ltd.544903951manufacture(69461-001)
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