PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Package Label - 30 Count Bottle MAJOR NDC 0904-6711-46 Original Prescription Strength FEXOFENADINE HYDROCHLORIDE Tablets USP, 180 mg / Antihistamine ALLERGY Indoor & Outdoor Allergies Non-Drowsy 24 HOUR 30 TABLETS 180 mg EACH
OTC - ACTIVE INGREDIENT SECTION.
Active ingredient (in each tablet) Fexofenadine HCl USP, 180 mg
INDICATIONS & USAGE SECTION.
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
DOSAGE & ADMINISTRATION SECTION.
Directions adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than1 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
SPL UNCLASSIFIED SECTION.
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 25C (68 and 77F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 4
INACTIVE INGREDIENT SECTION.
Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titantium dioxide
OTC - QUESTIONS SECTION.
Questions? call 1-888-375-3784
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 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.