Label: FEXOFENADINE HYDROCHLORIDE tablet

  • NDC Code(s): 55111-782-01, 55111-782-30, 55111-782-78, 55111-782-79, view more
    55111-782-90, 55111-783-01, 55111-783-24, 55111-783-28, 55111-783-30, 55111-783-60, 55111-783-78, 55111-783-79, 55111-783-90, 55111-784-01, 55111-784-05, 55111-784-07, 55111-784-15, 55111-784-18, 55111-784-23, 55111-784-28, 55111-784-29, 55111-784-30, 55111-784-35, 55111-784-40, 55111-784-43, 55111-784-45, 55111-784-59, 55111-784-75, 55111-784-78, 55111-784-79, 55111-784-90
  • Packager: Dr. Reddy's Laboratories Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 22, 2022

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  • Active ingredient(s)

    Fexofenadine HCl USP, 30 mg

    Fexofenadine HCl USP, 60 mg

    Fexofenadine HCl USP, 180 mg

  • Purpose

    Antihistamine

  • Use(s)

    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 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.

  • Directions

    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 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 printed foil inner seal on bottle is torn or missing
    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
    • this product meets the requirements of USP Dissolution Test 4

  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide

  • Questions?

    Call 1-888-375-3784

  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

    Bottle label:

    container180mg

  • PRINCIPAL DISPLAY PANEL

    Fexofenadine HCl Tablets, 30 mg Carton:

    carton30mg

  • PRINCIPAL DISPLAY PANEL

    Fexofenadine HCl Tablets USP, 60 mg Carton:

    carton60mg

  • PRINCIPAL DISPLAY PANEL

    Fexofenadine HCl Tablets USP, 180 mg Carton Label:

    carton

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-782
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    magnesium stearate (UNII: 70097M6I30)  
    mannitol (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    polyethylene glycol 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize4mm
    FlavorImprint Code 192;R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55111-782-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2011
    2NDC:55111-782-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2011
    3NDC:55111-782-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2011
    4NDC:55111-782-7810 in 1 CARTON01/03/2011
    4NDC:55111-782-7910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07650201/03/2011
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-783
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    magnesium stearate (UNII: 70097M6I30)  
    mannitol (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    polyethylene glycol 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize5mm
    FlavorImprint Code 193;R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55111-783-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2011
    2NDC:55111-783-6060 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2011
    3NDC:55111-783-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2011
    4NDC:55111-783-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2011
    5NDC:55111-783-7810 in 1 CARTON01/03/2011
    5NDC:55111-783-7910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:55111-783-282 in 1 CARTON12/01/2020
    66 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:55111-783-244 in 1 CARTON12/01/2020
    76 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07650201/03/2011
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-784
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize7mm
    FlavorImprint Code 194;R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55111-784-301 in 1 CARTON01/03/2011
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55111-784-432 in 1 CARTON01/03/2011
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:55111-784-401 in 1 CARTON01/03/2011
    340 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:55111-784-451 in 1 CARTON01/03/2011
    445 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:55111-784-592 in 1 CARTON01/03/2011
    560 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:55111-784-751 in 1 CARTON01/03/2011
    670 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:55111-784-901 in 1 CARTON01/03/2011
    790 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:55111-784-011 in 1 CARTON01/03/2011
    8100 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:55111-784-151 in 1 CARTON01/03/2011
    9150 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:55111-784-181 in 1 CARTON01/03/2011
    10180 in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:55111-784-051 in 1 CARTON01/03/2011
    11500 in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:55111-784-231 in 1 CARTON01/03/2011
    122 in 1 BLISTER PACK; Type 0: Not a Combination Product
    13NDC:55111-784-071 in 1 CARTON01/03/2011
    135 in 1 BLISTER PACK; Type 0: Not a Combination Product
    14NDC:55111-784-352 in 1 CARTON12/01/2021
    145 in 1 BLISTER PACK; Type 0: Not a Combination Product
    15NDC:55111-784-293 in 1 CARTON01/03/2011
    155 in 1 BLISTER PACK; Type 0: Not a Combination Product
    16NDC:55111-784-7810 in 1 CARTON01/03/2011
    16NDC:55111-784-7910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    17NDC:55111-784-283 in 1 CARTON01/03/2011
    1715 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07650201/03/2011
    Labeler - Dr. Reddy's Laboratories Limited (650562841)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Reddy's Laboratories Limited (FTO III)918608162analysis(55111-784, 55111-782, 55111-783) , manufacture(55111-784, 55111-782, 55111-783)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reed-Lane, Inc.001819879pack(55111-782, 55111-783, 55111-784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Quality Packaging Specialists International, LLC080629831pack(55111-784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Reddy's Laboratories Louisiana, LLC830397282pack(55111-784)
    Establishment
    NameAddressID/FEIBusiness Operations
    DR. REDDY'S LABORATORIES LIMITED 860037244analysis(55111-783) , manufacture(55111-783) , pack(55111-783, 55111-784)
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