Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)
Denton Pharma, Inc. dba Northwind Pharmaceuticals
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, FILM COATED DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS ---------- FEXOFENADINE HYDROCHLORIDE TABLETS, 60 MG DRUG FACTS ACTIVE INGREDIENT (IN EACH TABLET) Fexofenadine HCl 60 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 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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 do not use if carton is opened or printed foil under cap is broken or missing store between 20 -25 C (68 -77 F) protect from excessive moisture this product meets the requirements of USP _Dissolution Test 3_ INACTIVE INGREDIENTS colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide QUESTIONS OR COMMENTS? 1-800-719-9260 PRINCIPAL DISPLAY PANEL NDC: 70934-568-30 FEXOFENADINE HYDROCHLORIDE fexofenadine hcl tablet, film coated PRODUCT INFORMATION PRODUCT T Baca dokumen lengkapnya