Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 27, 2022

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  • Active ingredient (in each tablet)


    For 180 mg:
     Fexofenadine HCl, USP 180 mg

  • Purpose


    Antihistamine

  • Uses

    reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

  • Warnings


    Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

    • trouble swallowing
    • dizziness or loss of consciousness
    • swelling of tongue
    • swelling in or around mouth
    • trouble speaking
    • drooling
    • wheezing or problems breathing

    These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

    Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

  • Do not use

    • to prevent hives from any known cause such as:
      • foods
      • insect stings
      • medicines
      • latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
    • 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.
    • hives that are an unusual color, look bruised or blistered
    • hives that do not itch
  • 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.
    • symptoms do not improve after 3 days of treatment
    • the hives have lasted more than 6 weeks
  • 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.

  • Directions


    For 180 mg: 



    adults and children 12 years of age and over
    		take 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
  • Other information

    • safety sealed; do not use if inner safety seal is open or torn
    • 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?


    Call toll free 1-800-818-4555 weekdays.

  • Principal Display Panel


    For 180 mg : Label

    NDC 62756-545-15

    Fexofenadine Hydrochloride Tablets, USP

    180 mg

    HIVES

    (24 Hour)

    Reduces HIVES and Relieves ITCHING due to hives


    Antihistamine

    ORIGINAL PRESCRIPTION STRENGTH

    NON-DROWSY

    30 Tablets

    180 mg each

    Actual Size



    bottle



  • Principal Display Panel


    For 180 mg : Carton

    NDC 62756-545-15

    Fexofenadine Hydrochloride Tablets, USP

    180 mg

    HIVES

    (24 Hour)

    Reduces HIVES and Relieves ITCHING due to hives

     
    Antihistamine

    NON-DROWSY

    30 Tablets

    180 mg each

    Actual Size



    bottle-carton

  • Principal Display Panel


    For 180 mg : Blister Pack

    NDC 62756-545-15

    ORIGINAL PRESCRIPTION STRENGTH
     
    NON-DROWSY

    Fexofenadine Hydrochloride Tablets, USP

    180 mg

    HIVES

    (24 Hour)

    Reduces HIVES and Relieves ITCHING due to hives

     
    Antihistamine

    5 (1 x 5) Tablets

    180 mg each

    Actual Size

    DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN



    blister

  • Principal Display Panel

    For 180 mg : Blister Foil
    Fexofenadine Hydrochloride Tablets, USP

    24 Hour

    180 mg

    HIVES

    Antihistamine

    Mfg. by: Sun Pharmaceutical Ind. Ltd., India.



    foil
  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-545
    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
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code 545
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62756-545-271 in 1 CARTON06/30/2022
    1NDC:62756-545-315 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:62756-545-942 in 1 CARTON06/30/2022
    2NDC:62756-545-315 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:62756-545-253 in 1 CARTON06/30/2022
    3NDC:62756-545-315 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:62756-545-1530 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
    5NDC:62756-545-1745 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
    6NDC:62756-545-1870 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
    7NDC:62756-545-1990 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
    8NDC:62756-545-20150 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
    9NDC:62756-545-21180 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
    10NDC:62756-545-22300 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09156706/30/2022
    Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited650445203ANALYSIS(62756-545) , MANUFACTURE(62756-545)
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