Label: FEXOFENADINE HCL tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 10, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)
    Fexofenadine HCl 180 mg
  • Purpose
    Antihistamine
  • 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
  • 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 ...
  • 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 ...
  • Other information
    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 - USPDissolution Test 2 - DO NOT USE ...
  • Inactive ingredients
    anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic ...
  • Questions?
    call toll free - 1-800-630-8895
  • SPL UNCLASSIFIED SECTION
    Distributed by: Advanced Rx LLC - 1942 NE 163rd St North Miami Beach, FL 33162 U.S.A.
  • Package/Label Principal Display Panel
    NDC 80513-506-01 - Compare to the active ingredient in Allegra - ®Allergy 24 Hour Tablets - * Non-Drowsy - Allergy Relief - Fexofenadine HCL 180 mg - INDOOR & OUTDOOR ALLERGY - 24-Hour Allergy ...
  • INGREDIENTS AND APPEARANCE
    Product Information