Label: FEXOFENADINE HCL tablet, film coated

  • NDC Code(s): 68210-4148-4
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 8, 2023

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  • Drug Facts

  • 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

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

  • ASK DOCTOR

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

  • WHEN USING

    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

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek
    medical help right away. You may report side effects to FDA at 1-800-FDA-1088.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

     adults and children 12 years of age and overtake 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

  • Drug Facts (continued)

  • OTHER SAFETY INFORMATION

    Other information  safety sealed: do not use if printed foil inner
    seal on bottle is torn or missing  store between 20º and 25ºC (68º
    and 77ºF)  protect from excessive moisture

  • INACTIVE INGREDIENT

    Inactive ingredients colloidal silicone dioxide, croscarmellose sodium, hypromellose,
    magnesium stearate, microcrystalline cellulose, polyethylene
    glycol/macrogol, povidone, pregelatinized starch, red iron oxide,
    silica, titanium dioxide, yellow iron oxide.

  • QUESTIONS

    Questions or comments? call +1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    Allergy Relief
    Fexofenadine HCl Tablets, 180 mg - Antihistamine

    Indoor & Outdoor Allergies
    • Sneezing • Runny Nose
    • Itchy, Watery Eyes • Itchy Throat Or Nose

    Non-Drowsy

    4 tablets

    image description

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HCL 
    fexofenadine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4148
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (ORANGE (PEACH)) Scoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code 180
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4148-41 in 1 CARTON04/28/2021
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21013704/28/2021
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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