DOSAGE & ADMINISTRATION SECTION.


Directions. adults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours; do not take more than tablets in 24 hourschildren under 12 years of agedo not useadults 65 years of age and olderask doctorconsumers with kidney diseaseask doctor.

INULLCTIVE INGREDIENT SECTION.


Inactive ingredients. Butylated hydroxyanisole, crospovidone, FD&C Blue No. Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.

INDICATIONS & USAGE SECTION.


Uses. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:orunny nose osneezing oitchy, watery eyesoitching of the nose or throat. orunny nose osneezing oitchy, watery eyes. oitching of the nose or throat.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredient (in each tablet). Fexofenadine hydrochloride USP, 60 mg.

OTC - ASK DOCTOR SECTION.


Ask doctor before use if you have. kidney disease. Your doctor should determine if you need different dose.

OTC - DO NOT USE SECTION.


Do not use. if you have ever had an allergic reaction to this product or any of its ingredients.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children.. In case of overdose, get medical help or contact Poison Control Center right away.

OTC - PREGNULLNCY OR BREAST FEEDING SECTION.


If pregnant or breast-feeding,. ask health professional before use.

OTC - PURPOSE SECTION.


Purpose. Antihistamine.

OTC - QUESTIONS SECTION.


Questions or comments. Call 1-877-446-3679 (1-877-4-INFO-RX) Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

OTC - STOP USE SECTION.


Stop use and ask doctor if. an allergic reaction to this product occurs. Seek medical help right away.

OTC - WHEN USING SECTION.


When using this product. odo not take more than directedodo not take at the same time as aluminum or magnesium antacidsodo not take with fruit juices (see Directions). odo not take more than directed. odo not take at the same time as aluminum or magnesium antacids. odo not take with fruit juices (see Directions).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 60 mg. NDC 0378-0781-91Non-DrowsyFexofenadine HClTablets, USP60 mgAllergy12 HRAntihistamineIndoor/Outdoor Allergy ReliefoSneezingoRunny Nose oItchy, Watery Eyes oItchy Nose or ThroatRM-AR0781D3 60 Tablets Directionsadults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours; do not take more than tablets in 24 hourschildren under 12 years of agedo not useadults 65 years of age and olderask doctorconsumers with kidney diseaseask doctor. oSneezing. oRunny Nose oItchy, Watery Eyes oItchy Nose or Throat. Fexofenadine Hydrochloride Tablets 60 mg Bottle Label Front. Fexofenadine HCl Tablet, USP 60 mg Bottle Lable Back of Front Layer. Fexofenadine Hydrochloride Tablets 60 mg Bottle Label Back.

SPL UNCLASSIFIED SECTION.


Other information. oTamper Evident: do not use if foil seal under cap is missing, open or brokenostore between 20 to 25C (68 to 77F)oprotect from excessive moistureoMeets USP Dissolution Test 2. oTamper Evident: do not use if foil seal under cap is missing, open or broken. ostore between 20 to 25C (68 to 77F). oprotect from excessive moisture. oMeets USP Dissolution Test 2.

WARNINGS SECTION.


Warnings. Do not use. if you have ever had an allergic reaction to this product or any of its ingredients.. Ask doctor before use if you have. kidney disease. Your doctor should determine if you need different dose.. When using this product. odo not take more than directedodo not take at the same time as aluminum or magnesium antacidsodo not take with fruit juices (see Directions). odo not take more than directed. odo not take at the same time as aluminum or magnesium antacids. odo not take with fruit juices (see Directions). Stop use and ask doctor if. an allergic reaction to this product occurs. Seek medical help right away.. If pregnant or breast-feeding,. ask health professional before use.. Keep out of reach of children.. In case of overdose, get medical help or contact Poison Control Center right away.