TBX-FREE (LABURNUM ANAGYROIDES) STRIP [AAVISHKAR ORAL STRIPS PVT. LTD.]

TBX-FREE (LABURNUM ANAGYROIDES) STRIP [AAVISHKAR ORAL STRIPS PVT. LTD.]
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NDC 71750-001-01
Set ID 6297737d-6fd7-156d-e053-2991aa0ad9eb
Category HUMAN OTC DRUG LABEL
Packager Aavishkar Oral Strips Pvt. Ltd.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active ingredient - Laburnum anagyroides 1x

  • PURPOSE

    PURPOSE

    Homeopathic treatment of chronic nicothism

  • DOSAGE & ADMINISTRATION

    Directions and Use

    • For adults 18 years or older
    • For best results use TBX-FREE on your quit day
    • It is important to complete treatment. If you feel you need to use TBX-FREE for a longer period to keep from smoking, talk to your health care provider.
    • Reduce nicotine cravings associated with smoking cessation
    • If you smoke over 20 cigarettes a day, take 4 strips a day as needed
    • If you smoke under 20 cigarettes a day, use TBX-FREE as recommended below.
  • WARNINGS

    Do not use: In conjunction with another smoking cessation product; if you are taking prescription medication for depression or asthma; 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 doctor of pharmacist before use if you have: heart disease or an irregular hearbeat; high blood pressure; stomach ulcers; diabetes; allergies to other medications

    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.

    If pregnant or breast feeding, ask a health professional before use

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

  • 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

    Smoking cessation treatment

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Licorice, menthol, natural mint extract, pullulan, sucralose, sugar

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    TBX-FREE 
    laburnum anagyroides strip
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71750-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LABURNUM ANAGYROIDES POLLEN (UNII: JX345H5MPP) (LABURNUM ANAGYROIDES POLLEN - UNII:JX345H5MPP) LABURNUM ANAGYROIDES POLLEN1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    MINT (UNII: FV98Z8GITP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MENTHOL (UNII: L7T10EIP3A)  
    SUCROSE (UNII: C151H8M554)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    LICORICE (UNII: 61ZBX54883)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71750-001-01120 in 1 BOX; Type 0: Not a Combination Product01/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/11/2018
    Labeler - Aavishkar Oral Strips Pvt. Ltd. (872196103)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aavishkar Oral Strips Pvt. Ltd.872196103manufacture(71750-001)

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