Label: FEXOFENADINE HYDROCHLORIDE tablet

  • NDC Code(s): 51316-800-08, 51316-800-15, 51316-800-30, 51316-800-45, view more
    51316-800-70, 51316-800-90
  • Packager: CVS PHARMACY, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 16, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Fexofenadine HCl, USP 180 mg

  • Purpose

    Antihistamine

  • 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
  • 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 (1-800-222-1222).

  • 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 agedo not use
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask a doctor
  • Other information

    • safety sealed: do not use if carton is opened or if inner safety seal is torn or missing
    • store between 20° to 25°C (68° to 77°F)
    • protect from excessive moisture
  • Inactive ingredients

    croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide

  • Questions or comments?

    Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    CVS Pharmacy, Inc.
    One CVS Drive
    Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton

    CVS Health®

    Compare to the active ingredient in
    Allegra® Allergy 24 Hour Tablets*

    NDC 51316-800-70

    Allergy Relief

    FEXOFENADINE HYDROCHLORIDE
    TABLETS, USP 180 mg
    Antihistamine

    INDOOR/OUTDOOR
    ALLERGY RELIEF

    24
    HOUR

    • Sneezing
    • Runny nose
    • Itchy, watery eyes
    • Itchy nose or throat

    Non-Drowsy

    Package Contains
    One Bottle

    70 TABLETS

    Actual Size

    PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-800
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 545
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-800-901 in 1 CARTON09/20/2022
    190 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:51316-800-701 in 1 CARTON09/20/2022
    270 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:51316-800-451 in 1 CARTON09/20/2022
    345 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:51316-800-301 in 1 CARTON09/20/2022
    430 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:51316-800-151 in 1 CARTON09/20/2022
    515 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:51316-800-081 in 1 CARTON09/20/2022
    6180 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09156709/20/2022
    Labeler - CVS PHARMACY, INC (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited650445203MANUFACTURE(51316-800)
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