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:

Proficient Rx LP

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 HCL TABLET, FILM COATED
PROFICIENT RX LP
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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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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. (1-800-222-1222)
DIRECTIONS
adults and children 12 years of age
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)
and 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
OTHER INFORMATION
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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 PANEL
Compare to Allegra® Allergy active ingredient
Fexofenadine Hydrochloride Tablets, 60 mg
Antihistamine
Non-Drowsy
Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat
Original Prescription Strength
12 Hour
60 mg Each
Actual Size
Indoor & Outdoor Allergies
Allergy
Repackaged by:
Proficient Rx LP
Thousand Oaks, C