TBX-Free: Homeopathic Product Information

TBX-FREE- laburnum anagyroides pollen strip
Aavishkar Oral Strips Pvt. Ltd.

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.

Active ingredient — Laburnum anagyroides 1x

PURPOSE

Homeopathic treatment of chronic nicothism

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.

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

Smoking cessation treatment

INACTIVE INGREDIENTS

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

label
(click image for full-size original)

TBX-FREE
laburnum anagyroides strip
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71750-001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABURNUM ANAGYROIDES POLLEN (LABURNUM ANAGYROIDES POLLEN) LABURNUM ANAGYROIDES POLLEN 1 [hp_X]
Inactive Ingredients
Ingredient Name Strength
MINT
SUCRALOSE
MENTHOL
SUCROSE
PULLULAN
LICORICE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71750-001-01 120 STRIP in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 01/11/2018
Labeler — Aavishkar Oral Strips Pvt. Ltd. (872196103)
Establishment
Name Address ID/FEI Operations
Aavishkar Oral Strips Pvt. Ltd. 872196103 manufacture (71750-001)

Revised: 01/2018 Aavishkar Oral Strips Pvt. Ltd.

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