TBX-FREE- laburnum anagyroides strip

TBX-Free by

Drug Labeling and Warnings

TBX-Free by is a Homeopathic medication manufactured, distributed, or labeled by Aavishkar Oral Strips Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TBX-FREE 
laburnum anagyroides strip

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71750-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LABURNUM ANAGYROIDES POLLEN (UNII: JX345H5MPP) (LABURNUM ANAGYROIDES POLLEN - UNII:JX345H5MPP)	LABURNUM ANAGYROIDES POLLEN	1 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
MINT (UNII: FV98Z8GITP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MENTHOL (UNII: L7T10EIP3A)
SUCROSE (UNII: C151H8M554)
PULLULAN (UNII: 8ZQ0AYU1TT)
LICORICE (UNII: 61ZBX54883)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71750-001-01	120 in 1 BOX; Type 0: Not a Combination Product	01/12/2018

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	Business Operations
Aavishkar Oral Strips Pvt. Ltd.		872196103	manufacture(71750-001)