Label: FEXOFENADINE HYDROCHLORIDE tablet

  • NDC Code(s): 68210-0122-1, 68210-0122-3
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 7, 2023

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  • Drug Facts

  • Active ingredient (in each tablet)

    Fexofenadine HCl 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

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

  • ASK DOCTOR

    Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a
    different dose.

  • WHEN USING

    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

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek
    medical help right away. You may report side effects to FDA at 1-800-FDA-1088.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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 age do not use
     adults 65 years of age and older ask a doctor
     consumers with kidney disease ask a doctor

  • Drug Facts (continued)

  • OTHER SAFETY INFORMATION

    Other information  safety sealed: do not use if printed foil inner
    seal on bottle is torn or missing  store between 20º and 25ºC (68º
    and 77ºF)  protect from excessive moisture

  • INACTIVE INGREDIENT

    Inactive ingredients colloidal silicone dioxide, croscarmellose sodium, hypromellose,
    magnesium stearate, microcrystalline cellulose, polyethylene
    glycol/macrogol, povidone, pregelatinized starch, red iron oxide,
    silica, titanium dioxide, yellow iron oxide.

  • QUESTIONS

    Questions or comments? call +1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Spirit Pharmaceuticals LLC,
    Ronkonkoma, NY 11779

    ORG 03/19

    Manufactured by:
    Unique Pharmaceutical
    Laboratories
    (A Div. of J. B. Chemicals &
    Pharmaceuticals Ltd.)
    Mumbai 400 030, India
    Mfg. Lic. No.: G/1430

  • PRINCIPAL DISPLAY PANEL

    Valumeds™

    NDC 68210-0122-1
    non-drowsy
    FEXOFENADINE
    HYDROCHLORIDE
    TABLETS USP
    180 mg
    antihistamine

    24 Hour

    indoor & outdoor allergy relief
    • sneezing • runny nose
    • itchy, watery eyes
    • itchy nose or throat

    100 tablets

    Actual Size 

    image description

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0122
    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
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code 180
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0122-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2019
    2NDC:68210-0122-31 in 1 CARTON09/18/2020
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21013703/21/2019
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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