TBX-FREE (CYTISINE) STRIP [DALIAN JIXIN ELECTRONIC INFORMATION CO., LTD.]

TBX-FREE (CYTISINE) STRIP [DALIAN JIXIN ELECTRONIC INFORMATION CO., LTD.]
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NDC 69461-001-01
Set ID 24fdfded-5d47-07a4-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Dalian Jixin Electronic Information Co., Ltd.
Generic Name
Product Class
Product Number
Application Number
  • 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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