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:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

FEXOFENADINE HYDROCHLORIDE

Composition:

FEXOFENADINE HYDROCHLORIDE 180 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FEXOFENADINE HCL- FEXOFENADINE HCL TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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FEXOFENADINE HYDROCHLORIDE TABLETS USP, 180 MG
ALLERGY
_ALLERGY_
_ACTIVE INGREDIENT (IN EACH FILM-COATED TABLET)_
Fexofenadine HCl USP, 180 mg
_PURPOSE_
Antihistamine
_USES_
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.
DIRECTIONS
adults and children 12 years of
age and over
take one 180mg 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_
safety sealed: do not use if carton is opened or if printed foil inner
seal on bottle is torn or missing
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
each tablet contains: sodium 8.2 mg
this product meets the requirements of USP Dissolution Test 2
INACTIVE INGREDIENTS
anhydrous lactose, colloidal silicon dioxide, corn starch,
croscarmellose sodium, lactose monohydrate,
pregelatinized starch (maize), stearic acid, opadry pink 03B84893
containing hypromellose,
polyethylene glycol, red iron oxide, titanium dioxide and yellow iron
oxide.
QUESTIONS OR COMMENTS?
Call 1-888-588-1418
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