Label: TBX-FREE- laburnum anagyroides strip
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Contains inactivated NDC Code(s)
NDC Code(s): 69305-002-01 - Packager: Advanced Men’s Institute LLC
- 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 January 12, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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:
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Day 1-2 Day 3-5 Day 6-12 Day 13-19 Day 20-30 Day 31 + Take 8 strips per day Take 6 strips per day Take 5 strips per day Take 4 strips per day Take 2 stips per day Take 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
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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
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TBX-FREE
laburnum anagyroides stripProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69305-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LABURNUM ANAGYROIDES FLOWERING TOP (UNII: A3V9296222) (LABURNUM ANAGYROIDES FLOWERING TOP - UNII:A3V9296222) LABURNUM ANAGYROIDES FLOWERING TOP 1 [hp_X] in 10 [hp_X] Inactive Ingredients Ingredient Name Strength MINTLACTONE (UNII: X2T3I06CWR) SUCROSE (UNII: C151H8M554) LICORICE (UNII: 61ZBX54883) PULLULAN (UNII: 8ZQ0AYU1TT) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69305-002-01 120 [hp_X] in 1 BOX; Type 0: Not a Combination Product 04/19/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/19/2016 Labeler - Advanced Men’s Institute LLC (079526408) Establishment Name Address ID/FEI Business Operations Dalian Jixin 079526408 manufacture(69305-002)
