TBX-FREE (LABURNUM ANAGYROIDES) STRIP [ADVANCED MEN’S INSTITUTE LLC]

TBX-FREE (LABURNUM ANAGYROIDES) STRIP [ADVANCED MEN’S INSTITUTE LLC]
PDF | XML

NDC 69305-002-01
Set ID 322009fc-0379-6320-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Advanced Men’s Institute LLC
Generic Name
Product Class
Product Number
Application Number
  • PURPOSE

    PURPOSE

    Homeopathic treatment of chronic nicotinism

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    Incase of overdose, get medical help or contact your poison control center right away

  • INDICATIONS & USAGE

    Use

    Smoking cessation treatment

  • DOSAGE & ADMINISTRATION

    DIRECTIONS
    •Adults 18 years or older
    •Begin using 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:
      • Day 1-2Day 3-5Day 6-12Day 13-19Day 20-30Day 31 +
        Take 8 strips per dayTake 6 strips per dayTake 5 strips per dayTake 4 strips per dayTake 2 stips per dayTake 1-4 strips per day as needed
        It is important to complete treatment: most will see best result after using TBX-FREE for 60-90 days

  • WARNINGS

    WARNING

    • 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)
    • If pregnant or breast feeing, 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.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Pullulan, Natural mint extract, Sugar, Menthol, Licorice, Sucralose

  • SPL UNCLASSIFIED SECTION

    OTHER INFORMATION
    •protect from excessive moisture and heat
    •store between 15° to 25° C (59° to 77° F)

    • Do not use if tamper-evident seal is broken
    • Phenylketonurics: Contains Phenylalanine .22 mg Per Strip

    QUESTIONS OR COMMENTS?

    1-800-404-4686

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    Laburnum anagyroides 1X

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    TBX-FREE 
    laburnum anagyroides strip
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69305-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LABURNUM ANAGYROIDES FLOWERING TOP (UNII: A3V9296222) (LABURNUM ANAGYROIDES FLOWERING TOP - UNII:A3V9296222) LABURNUM ANAGYROIDES FLOWERING TOP1 [hp_X]  in 10 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    MINTLACTONE (UNII: X2T3I06CWR)  
    SUCROSE (UNII: C151H8M554)  
    LICORICE (UNII: 61ZBX54883)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69305-002-01120 [hp_X] in 1 BOX; Type 0: Not a Combination Product04/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/19/2016
    Labeler - Advanced Men’s Institute LLC (079526408)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalian Jixin079526408manufacture(69305-002)

Related Drugs