País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)
Mylan Institutional Inc.
FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE 60 mg
ORAL
OTC DRUG
Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: - runny nose - sneezing - itchy, watery eyes - itching of the nose or throat if you have kidney disease. Your doctor should determine if you need a different dose. an allergic reaction to this product occurs. Seek medical help right away.
Fexofenadine Hydrochloride Tablets, USP are available containing 60 mg or 180 mg of fexofenadine hydrochloride, USP. The 60 mg tablets are blue film-coated, round, biconvex, beveled edge, unscored tablets debossed with M over 753 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-547-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each). The 180 mg tablets are blue film-coated, caplet-shaped, biconvex, beveled edge, unscored tablets debossed with M 755 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-548-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from excessive moisture. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-11117 R4 12/16
Abbreviated New Drug Application
FEXOFENADINE HYDROCHLORIDE- FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED MYLAN INSTITUTIONAL INC. ---------- DRUG FACTS _Non-Drowsy_ INDOOR/OUTDOOR ALLERGY RELIEF TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. ACTIVE INGREDIENT (IN EACH TABLET) Fexofenadine hydrochloride USP PURPOSE Antihistamine USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes 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. _DIRECTIONS - 60 MG (12 HOUR RELIEF)_ 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 _DIRECTIONS - 180 MG (24 HOUR RELIEF)_ 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 TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. STORE AT 20° TO 25°C (68° TO 77°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] PROTECT FROM EXCESSIVE MOISTURE INACTIVE INGREDIENTS Butylated hyd Leia o documento completo