Label: ALLERGY RELIEF NON DROWSY- fexofenadine hcl tablet, film coated

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

Drug Label Information

Updated May 19, 2022

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

  • Active ingredient(s)

    Fexofenadine HCl 60mg

  • Purpose

    Antihistamine

  • Use(s)

    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
  • 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.

    Pregnancy/Breastfeeding

    ask a health professional before use.

    Keep out of reach of children

    In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults and children 12 years of age and over: take one 60 mg caplet with water every 12 hours; do not take more than 2 caplets 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



  • Other information

    •  store at room temperature 20°– 25°C (68°– 77°F)
    •  protect from excessive moisture
    • do not use if imprinted seal under safety cap is broken or missing
  • 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, pregelatinized starch, purified water, titanium dioxide

  • Questions

    Questions or comments?
    Call 1-888-952-0050
    Monday through Friday 9AM - 5PM

  • Principal Display Panel

    Fexo 60mg

    Fexo 60mg


  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF  NON DROWSY
    fexofenadine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-437
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorpink (Peach) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code G5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-437-98200 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107505/18/2022
    Labeler - Allegiant Health (079501930)