Label: CRCLE FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet

  • NDC Code(s): 57483-230-01, 57483-240-02
  • Packager: Innovus Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 8, 2023

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  • Active ingredient 

    Fexofenadine HCl USP 60 mg (for 60 mg)

    Fexofenadine HCl USP 180 mg (for 180 mg)

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose 
    • sneezing 
    • itchy, watery eyes
    •  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 a 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 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 imprinted foil 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?

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

  • PRINCIPAL DISPLAY PANEL

    C'rcle Allergy Relief

    Fexofenadine HCl Tablets, USP 60 mg

    Antihistamine

    100 Tablets

    Fexofenadine 60 mg

    NDC 57483-240-02

    C'rcle Allergy Relief

    Fexofenadine HCl Tablets, USP 180 mg

    Antihistamine

    150 Tablets

    Fexofenadine 180 mg

  • INGREDIENTS AND APPEARANCE
    CRCLE FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-230
    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:57483-230-01100 in 1 CONTAINER; Type 0: Not a Combination Product04/28/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107512/18/2020
    CRCLE FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-240
    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
    ShapeOVAL (capsule shaped) Size17mm
    FlavorImprint Code G6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57483-240-02150 in 1 CONTAINER; Type 0: Not a Combination Product04/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107512/18/2020
    Labeler - Innovus Pharmaceuticals, Inc. (962507187)
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