Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 62756-542-15, 62756-542-16, 62756-542-27, 62756-542-28, view more
    62756-542-29, 62756-542-30, 62756-542-94, 62756-542-95, 62756-543-15, 62756-543-16, 62756-543-27, 62756-543-28, 62756-543-29, 62756-543-30, 62756-543-94, 62756-543-95, 62756-545-15, 62756-545-16, 62756-545-27, 62756-545-28, 62756-545-29, 62756-545-30, 62756-545-94, 62756-545-95
  • Packager: Sun Pharmaceutical Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 26, 2018

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

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-542
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPINKScoreno score
    ShapeROUND (circular) Size6mm
    FlavorImprint Code 542
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62756-542-1530 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
    2NDC:62756-542-16100 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
    3NDC:62756-542-271 in 1 CARTON02/06/2012
    35 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:62756-542-942 in 1 CARTON02/06/2012
    45 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:62756-542-289 in 1 CARTON02/06/2012
    55 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:62756-542-955 in 1 CARTON02/06/2012
    66 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:62756-542-2910 in 1 CARTON02/06/2012
    76 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:62756-542-3015 in 1 CARTON02/06/2012
    86 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09156702/06/2012
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-543
    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
    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
    ColorPINKScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 543
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62756-543-1530 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
    2NDC:62756-543-16100 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
    3NDC:62756-543-271 in 1 CARTON02/06/2012
    35 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:62756-543-942 in 1 CARTON02/06/2012
    45 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:62756-543-289 in 1 CARTON02/06/2012
    55 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:62756-543-955 in 1 CARTON02/06/2012
    66 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:62756-543-2910 in 1 CARTON02/06/2012
    76 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:62756-543-3015 in 1 CARTON02/06/2012
    86 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09156702/06/2012
    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
    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
    ColorPINKScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code 545
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62756-545-1530 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
    2NDC:62756-545-16100 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
    3NDC:62756-545-271 in 1 CARTON02/06/2012
    35 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:62756-545-942 in 1 CARTON02/06/2012
    45 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:62756-545-289 in 1 CARTON02/06/2012
    55 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:62756-545-955 in 1 CARTON02/06/2012
    66 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:62756-545-2910 in 1 CARTON02/06/2012
    76 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:62756-545-3015 in 1 CARTON02/06/2012
    86 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09156702/06/2012
    Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited650445203ANALYSIS(62756-542, 62756-543, 62756-545) , LABEL(62756-543) , MANUFACTURE(62756-542, 62756-543, 62756-545) , PACK(62756-543)