Home > Drugs A-Z > FEXOFENADINE HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE (Sun Pharmaceutical Industries Limited)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 100 TABLET, FILM COATED in 1 BOTTLE (62756-542-88) Label Information
TABLET, FILM COATED 30 TABLET, FILM COATED in 1 BOTTLE (62756-542-15) Label Information
TABLET, FILM COATED 100 TABLET, FILM COATED in 1 BOTTLE (62756-542-16) Label Information
TABLET, FILM COATED 30 TABLET, FILM COATED in 1 BOTTLE (62756-542-83) Label Information

Complete FEXOFENADINE HYDROCHLORIDE Information

  • Active ingredient (in each tablet)


    For 30 mg:
    Fexofenadine HCl, USP 30 mg

    For 60 mg:
    Fexofenadine HCl, USP 60 mg

    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 30 mg:


    adults and children 12 years of age and over
    take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours
    children 6 to under 12 years of age
    take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
    children under 6 years of age
    do not use
    adults 65 years of age and older
    ask a doctor
    consumers with kidney disease
    ask a doctor

    For 60 mg:


    adults and children 12 years of age and over
    take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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

    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


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


  • Questions?


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


  • Principal Display Panel


    For 30 mg Hives Relief:



    NDC 62756-542-16
    Children's
    Fexofenadine Hydrochloride Tablets, USP
    30 mg
    HIVES
    (12 Hour)
    Antihistamine

    Relief of ITCHING Due to Hives
    100 Tablets 30 mg each
    SUN PHARMA 



    30mg-hives-relief-1

    30mg-hives-relief-2


    30mg-hives-relief-3

    30mg-hives-relief-4

    30mg-hives-relief-5

    30mg-hives-relief-6

    30mg-hives-relief-7

    30mg-hives-relief-8

    30mg-hives-relief-9


    For 60 mg Hives Relief:

    NDC 62756-543-16 Fexofenadine Hydrochloride Tablets, USP
    60 mg
    HIVES
    (12 Hour)
    Antihistamine

    Relief of ITCHING Due to Hives
    100 Tablets 60 mg each
    SUN PHARMA


    60mg-hives-relief-1

    60mg-hives-relief-2

    60mg-hives-relief-3


    For 180 mg Hives Relief:



    NDC 62756-545-16
    Fexofenadine Hydrochloride Tablets, USP
    180 mg
    HIVES
    (24 Hour)
    Antihistamine
    Relief of ITCHING Due to Hives
    100 Tablets 180 mg each
    SUN PHARMA


    180mg-hives-relief-1

    180mg-hives-relief-2

    180mg-hives-relief-3

  • Principal Display Panel

    For 30 mg Hives Relief:

    NDC 62756-542-27
    ORIGINAL PRESCRIPTION STRENGTH
    NON-DROWSY
    Children's
    Fexofenadine Hydrochloride Tablets, USP
    30 mg
    HIVES
    (12 Hour)
    Antihistamine
    Relief of ITCHING Due to Hives
    Ages 6 years and Older
    5 (1 x 5)Tablets 30 mg each
    SUN PHARMA
    DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
    30mg-hives-sb


  • Principal Display Panel

    For 60 mg Hives Relief:

    NDC 62756-543-27
    ORIGINAL PRESCRIPTION STRENGTH
    NON-DROWSY
    Fexofenadine Hydrochloride Tablets, USP
    60 mg
    HIVES
    (12 Hour)
    Antihistamine
    Relief of ITCHING Due to Hives
    5 (1 x 5)Tablets 60 mg each
    SUN PHARMA
    DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
    60mg-hives-sb


  • Principal Display Panel

    For 180 mg Hives Relief:

    NDC 62756-545-27
    ORIGINAL PRESCRIPTION STRENGTH
    NON-DROWSY
    Fexofenadine Hydrochloride Tablets, USP
    180 mg
    HIVES
    (24 Hour)
    Antihistamine
    Relief of ITCHING Due to Hives
    5 (1 x 5)Tablets 180 mg each
    SUN PHARMA
    DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
    180mg-hives-sb


  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62756-542
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    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
    Color PINK Score no score
    Shape ROUND (circular) Size 6mm
    Flavor Imprint Code 542
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62756-542-15 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/06/2012
    2 NDC:62756-542-16 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/06/2012
    3 NDC:62756-542-27 1 in 1 CARTON 02/06/2012
    3 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4 NDC:62756-542-94 2 in 1 CARTON 02/06/2012
    4 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5 NDC:62756-542-28 9 in 1 CARTON 02/06/2012
    5 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6 NDC:62756-542-95 5 in 1 CARTON 02/06/2012
    6 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7 NDC:62756-542-29 10 in 1 CARTON 02/06/2012
    7 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8 NDC:62756-542-30 15 in 1 CARTON 02/06/2012
    8 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091567 02/06/2012
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62756-543
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 60 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    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
    Color PINK Score no score
    Shape OVAL Size 12mm
    Flavor Imprint Code 543
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62756-543-15 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/06/2012
    2 NDC:62756-543-16 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/06/2012
    3 NDC:62756-543-27 1 in 1 CARTON 02/06/2012
    3 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4 NDC:62756-543-94 2 in 1 CARTON 02/06/2012
    4 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5 NDC:62756-543-28 9 in 1 CARTON 02/06/2012
    5 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6 NDC:62756-543-95 5 in 1 CARTON 02/06/2012
    6 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7 NDC:62756-543-29 10 in 1 CARTON 02/06/2012
    7 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8 NDC:62756-543-30 15 in 1 CARTON 02/06/2012
    8 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091567 02/06/2012
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62756-545
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 180 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    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
    Color PINK Score no score
    Shape CAPSULE Size 17mm
    Flavor Imprint Code 545
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62756-545-15 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/06/2012
    2 NDC:62756-545-16 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/06/2012
    3 NDC:62756-545-27 1 in 1 CARTON 02/06/2012
    3 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4 NDC:62756-545-94 2 in 1 CARTON 02/06/2012
    4 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5 NDC:62756-545-28 9 in 1 CARTON 02/06/2012
    5 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6 NDC:62756-545-95 5 in 1 CARTON 02/06/2012
    6 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7 NDC:62756-545-29 10 in 1 CARTON 02/06/2012
    7 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8 NDC:62756-545-30 15 in 1 CARTON 02/06/2012
    8 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091567 02/06/2012
    Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
    Establishment
    Name Address ID/FEI Business Operations
    Sun Pharmaceutical Industries Limited 650445203 ANALYSIS(62756-542, 62756-543, 62756-545) , LABEL(62756-543) , MANUFACTURE(62756-542, 62756-543, 62756-545) , PACK(62756-543)