FEXOFENADINE HYDROCHLORIDE- fexofenadine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

FEXOFENADINE HYDROCHLORIDE

Composition:

FEXOFENADINE HYDROCHLORIDE 60 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FEXOFENADINE HYDROCHLORIDE- FEXOFENADINE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Fexofenadine hydrochloride USP, 60 mg
PURPOS E
Antihistamine
US ES
temporarily relieves these symptoms due to hay fever or other upper
respiratory allergies:
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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
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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
adults and children 12 years of age take one 60 mg tablet with water
every 12 hours; do not take more
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
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)
and over
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
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INACTIVE INGREDIENTS
Butylated hydroxyanisole, crospovidone, FD&C Blue No. 1 Aluminum Lake,
hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polydextrose, polyethylene glycol,
polysorbate 80, povidone, sodium lauryl sulfate, titanium dioxide and
triacetin.
QUESTIONS OR COMMENTS?
Call 1-877-446-3679 (1-877-4-INFO-RX)
Manufactured by: MYLAN PHARMACEUTICALS INC., Morgantown, WV 26505
U.S.A.
PRINCIPAL DISPLAY PANEL - 60 MG
NDC 0378-0781-91
_Non-Drowsy_
FEXOFENADINE HCL
TABLETS, USP
60 MG
ALLERGY
12 HR
ANTIHISTAMINE
INDOOR/OUTDOOR ALLERGY RELIEF
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RM-AR0781D3 60 TABLETS
DIRECTIONS
adults and children 12 years of a