Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)
Aphena Pharma Solutions - Tennessee, LLC
ORAL
OTC DRUG
Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: - runny nose - itchy, watery eyes - sneezing - itching of the nose or throat
Abbreviated New Drug Application
FEXOFENADINE HYDROCHLORIDE- FEXOFENADINE HCL TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- MAJOR PHARMACEUTICALS ACTIVE INGREDIENT (IN EACH FILM-COATED TABLET) Fexofenadine HCL 180 mg PURPOS E Antihistamine US ES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat WARNINGS DO NOT USE if you have ever had an allergic reaction to this product or any of its ingredients. ASK A DOCTOR BEFORE USE IF YOU HAVE kidney disease. Your doctor should determine if you need a different dose. WHEN USING THIS PRODUCT do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) STOP USE AND ASK A DOCTOR IF an allergic reaction to this product occurs. Seek medical help right away. 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 (1-800-222-1222). DIRECTIONS adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor OTHER INFORMATION EACH TABLET CONTAIN: sodium 8 mg store between 20 to 25°C (68 to 77°F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 2 INACTIVE INGREDIENTS anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide QUESTIONS OR COMMENTS? Call: 1-800-616-2471 REPACKAGING INFORMATION Please reference the _HOW SUPPLIED_ section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distribut Baca dokumen lengkapnya