FEXOFENADINE HYDROCHLORIDE tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

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Herunterladen Fachinformation (SPC)
03-02-2012

Wirkstoff:

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

Verfügbar ab:

Dispensing Solutions, Inc.

INN (Internationale Bezeichnung):

FEXOFENADINE HYDROCHLORIDE

Zusammensetzung:

FEXOFENADINE HYDROCHLORIDE 180 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

OTC DRUG

Anwendungsgebiete:

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

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

                                FEXOFENADINE HYDROCHLORIDE - FEXOFENADINE HYDROCHLORIDE TABLET, FILM
COATED
DISPENSING SOLUTIONS, INC.
----------
MAJOR PHARMACEUTICALS FEXOFENADINE HYDROCHLORIDE TABLETS, 180 MG DRUG
FACTS
ACTIVE INGREDIENT (IN EACH 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
take one 180 mg tablet with water once a day; do not take more than
age and over
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
do not use if blister unit is broken or torn (Use for Blister
Configurations Only)
do not use if printed foil under cap is broken or missing (Use for
Bottle Configurations Only)
store at 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
PACKAGE/LABEL PRINCIPAL DISPLAY
                                
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