Label: FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated

  • NDC Code(s): 62207-889-49, 62207-889-51, 62207-889-60, 62207-891-49, view more
    62207-891-51, 62207-891-58
  • Packager: Granules India Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 13, 2023

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  • Active ingredient (in each tablet)

    Fexofenadine HCl USP, 60 mg (for 60 mg)

    Fexofenadine HCl USP, 180 mg (for 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 immediatelyif 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
    • wheezing or problems breathing
    • drooling

    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 preventhives 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 a 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

    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 (for 60 mg)
    take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg) 
     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 foil printed with granules logo under bottle cap is opened or torn.
    • store between 20º and 25ºC (68º and 77ºF)
    • protect from excessive moisture
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide.

  • Questions or comments?

    Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

    Manufactured By:
    Granules India Limited    
    Hyderabad-500 081, India

     

    MADE IN INDIA

    Distributed By:
    Granules USA, Inc.
    Parsippany, NJ 07054

  • PRINCIPAL DISPLAY PANEL 60 mg - 10s Container Label

    NDC 62207-889-51                    New!

                                      NON-DROWSY

    Fexofenadine HCl

    Tablets, USP 60 mg

    Hives

    Antihistamine

    REDUCES HIVES and            12 HR

    RELIEVES ITCHING

    due to hives

     

    10 Tablets

    *Compare to the active ingredient in

    Allegra ®Hives 12 HOUR 

    fexofenadine-60mg-10s-label

  • PRINCIPAL DISPLAY PANEL 60 mg - 10s Container Carton

    NDC 62207-889-51                 

                                                        New!

                                      NON-DROWSY

    Fexofenadine HCl

    Tablets, USP

    60 mg

     Hives

    Antihistamine

    REDUCES HIVES and            

    RELIEVES ITCHING

    due to hives

                                                 12 HR

    10 Tablets

    *Compare to the active ingredient in

    Allegra ® Hives 12 HOUR


    fexofenadine-60mg-10s-carton
  • PRINCIPAL DISPLAY PANEL 60 mg - Blister Carton

    NDC 62207-889-60               

                                                                                      New!

                                                                    NON-DROWSY

    Fexofenadine HCl Tablets USP, 60 mg

     Hives

    Antihistamine

    REDUCES HIVES and                           12 HR

    RELIEVES ITCHING

    due to hives

                                  

                                                                             72 (8 x 9) Tablets

    *Compare to the active ingredient in Allegra ® Hives 12 HOUR


    fexofenadine-60mg-blister-carton

  • PRINCIPAL DISPLAY PANEL 180 mg - 10s Container Label

    NDC 62207-891-51                    New!

                                      NON-DROWSY

    Fexofenadine HCl

    Tablets, USP 180 mg

    Hives

    Antihistamine

    REDUCES HIVES and           24 HR

    RELIEVES ITCHING

    due to hives

    10 Tablets

    *Compare to the active ingredient in

    Allegra ® Hives 24 HOUR 


    fexofenadine-180mg-10s-label

  • PRINCIPAL DISPLAY PANEL 180 mg - 10s Container Carton

    NDC 62207-891-51                 

                                                        New!

                                      NON-DROWSY

    Fexofenadine HCl

    Tablets, USP

    180 mg

    Hives

    Antihistamine

    REDUCES HIVES and             24 HR

    RELIEVES ITCHING

    due to hives

                                                  

    10 Tablets

    *Compare to the active ingredient in

    Allegra ® Hives 24 HOUR


    fexofenadine-180mg-10s-carton
  • PRINCIPAL DISPLAY PANEL 180 mg - Blister Carton

    NDC 62207-891-58                                              New!

                                                                NON-DROWSY

    Fexofenadine HCl Tablets USP, 180 mg

    Hives

    Antihistamine

     

    REDUCES HIVES and                         24 HR

    RELIEVES ITCHING

    due to hives

     

                                                                 70 (7 x 10) Tablets

    *Compare to the active ingredient in Allegra ® Hives 24 HOUR 


    fexofenadine-180mg-blister-carton

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE  
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-889
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (PEACH) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code G5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-889-511 in 1 CARTON11/07/2023
    110 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:62207-889-491000 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2023
    3NDC:62207-889-608 in 1 CARTON11/07/2023
    39 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107511/07/2023
    FEXOFENADINE HYDROCHLORIDE  
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-891
    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)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (PEACH) Scoreno score
    ShapeCAPSULE (CAPSULE) Size17mm
    FlavorImprint Code G6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-891-511 in 1 CARTON11/07/2023
    110 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:62207-891-491000 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2023
    3NDC:62207-891-587 in 1 CARTON11/07/2023
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107511/07/2023
    Labeler - Granules India Limited (915000087)
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