- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
-
WARNINGS
Warnings
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
TBX-FREE
cytisine stripProduct 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)