Label: TBX-FREE- laburnum anagyroides strip
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Contains inactivated NDC Code(s)
NDC Code(s): 71750-001-01 - Packager: Aavishkar Oral Strips Pvt. Ltd.
- 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)
- ACTIVE INGREDIENT
- PURPOSE
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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.
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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
- INDICATIONS & USAGE
- INACTIVE 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: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)