FEXOFENADINE HYDROCHLORIDE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)

Tilgjengelig fra:

Mylan Institutional Inc.

INN (International Name):

FEXOFENADINE HYDROCHLORIDE

Sammensetning:

FEXOFENADINE HYDROCHLORIDE 60 mg

Administreringsrute:

ORAL

Resept typen:

OTC DRUG

Indikasjoner:

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.

Produkt oppsummering:

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

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

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