Label: TBX-FREE- cytisine strip
Contains inactivated NDC Code(s)
NDC Code(s): 69461-001-01
- Packager: Dalian Jixin Electronic Information Co., 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.
Updated November 20, 2015
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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)
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69461-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYTISINE (UNII: 53S5U404NU) (CYTISINE - UNII:53S5U404NU) CYTISINE 8 mg in 1 mg Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) MENTHOL (UNII: L7T10EIP3A) LICORICE (UNII: 61ZBX54883) PULLULAN (UNII: 8ZQ0AYU1TT) MINT (UNII: FV98Z8GITP) ASPARTAME (UNII: Z0H242BBR1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69461-001-01 110 mg in 1 BOX; Type 0: Not a Combination Product 11/20/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/20/2015 Labeler - Dalian Jixin Electronic Information Co., Ltd. (544903951) Establishment Name Address ID/FEI Business Operations Dalian Jixin Electronic Information Co., Ltd. 544903951 manufacture(69461-001)