Label: FEXOFENADINE HYDROCHLORIDE tablet

  • NDC Code(s): 62207-623-41, 62207-623-45, 62207-623-57, 62207-623-71
  • Packager: Granules India Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 8, 2024

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  • Active ingredient (in each tablet)

    Fexofenadine HCl USP, 180 mg

  • Purpose

    Antihistamine

  • Uses

    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 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 overtake 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 individual blister units are torn or opened
    • store between 20º and 25ºC (68º and 77ºF)
    • protect from excessive moisture
  • Inactive ingredients

    ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D & C Red 33, ferrosoferric oxide, FD & C blue 1, FD & C yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, 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 180 mg - 24s Container Label

    NDC 62207-623-41

    NON-DROWSY

    Fexofenadine HCl

    Tablets USP, 180 mg

    Allergy

    Antihistamine

    INDOOR / OUTDOOR ALLERGY
    RELIEF 24HR

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Nose or Throat

    24 GELCAPS

    Gel Coated Tablets

    *Compare to the active ingredient in

    Allegra ® Allergy 24 HOUR

    fexo-container-label

  • PRINCIPAL DISPLAY PANEL 180 mg -24s Container Carton

    NDC 62207-623-41
    NON-DROWSY


    Fexofenadine HCl
    Tablets, USP

    180 mg

    Allergy

    Antihistamine
    INDOOR / OUTDOOR ALLERGY
    RELIEF 24 HR

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Nose or Throat

    24 GELCAPS
    Gel Coated Tablets

    *Compare to the active ingredient in Allegra ®

    Allergy 24 HOUR


    fexo-container-carton

  • PRINCIPAL DISPLAY PANEL 180 mg - Blister Carton

    NDC 62207-623-71
    NON-DROWSY


    Fexofenadine HCl Tablets USP, 180 mg

    Allergy


    Antihistamine


    INDOOR / OUTDOOR ALLERGY
    RELIEF 24 HR

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Nose or Throat

    70 (7x10) GELCAPS

    Gel Coated Tablets


    *Compare to the active ingredient in ALLEGRA ® ALLERGY 24 HOUR

    fexo-blister-carton

  • PRINCIPAL DISPLAY PANEL 180 mg - Blister Foil

    NDC 62207-623-71
    Fexofenadine HCl
    Tablet USP, 180 mg
    Allergy

    Antihistamine (GELCAP)
    Mfg. by: Granules India Limited
    Made in India

    M.L.No.: 37/RR/AP/2003/F/R 24 HR
    Push tablet through foil

    LOT#
    EXP. DATE:

    fexo-blister foil

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-623
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SHELLAC (UNII: 46N107B71O)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    Colorgray (WHITE BAND IN THE MIDDLE) Scoreno score
    ShapeOVAL (capsule shaped) Size20mm
    FlavorImprint Code G18
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-623-717 in 1 CARTON01/02/2024
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:62207-623-4124 in 1 CONTAINER; Type 0: Not a Combination Product01/02/2024
    3NDC:62207-623-5790 in 1 CONTAINER; Type 0: Not a Combination Product01/02/2024
    4NDC:62207-623-45225 in 1 CONTAINER; Type 0: Not a Combination Product01/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107501/02/2024
    Labeler - Granules India Limited (915000087)
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