FEXOFENADINE HYDROCHLORIDE- fexofenadine hcl 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:

Carilion Materials Management

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Product summary:

Product: 68151-1452 NDC: 68151-1452-7 1 TABLET, FILM COATED in a PACKAGE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FEXOFENADINE HYDROCHLORIDE- FEXOFENADINE HCL TABLET, FILM COATED
CARILION MATERIALS MANAGEMENT
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PERRIGO 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:
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•
•
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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
•
•
•
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 take one 60 mg tablet with
water every 12 hours; do not take
runny nose
itchy, watery eyes
sneezing
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)
over
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
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•
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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
HOW SUPPLIED
Product: 68151-1452
NDC: 68151-1452-7 1 TABLET, FILM COATED in a PACKAGE
FEXOFENADINE HCL 60 MG TAB
FEXOFENADINE HYDROCHLORIDE
fexofenadine hcl tablet, film coated
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8