PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL - 180 mg NDC 0378-0782-93 Non-Drowsy Fexofenadine HCl Tablets, USP 180 mg Allergy 24 HR Antihistamine Indoor/Outdoor Allergy Relief Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat RM-AR0782H330 Tablets Directions adults and children 12 years of age and over take one 180 mg 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
OTC - ACTIVE INGREDIENT SECTION.
Active ingredient (in each tablet) Fexofenadine hydrochloride USP, 60 mg
INDICATIONS & USAGE SECTION.
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
DOSAGE & ADMINISTRATION SECTION.
Directions adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take 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
SPL UNCLASSIFIED SECTION.
Other information Tamper Evident: do not use if foil seal under cap is missing, open or broken store between 20 to 25C (68 to 77F) protect from excessive moisture Meets USP Dissolution Test 2
INACTIVE INGREDIENT SECTION.
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.
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.
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.
OTC - PURPOSE SECTION.