Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 11, 2019

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  • ACTIVE INGREDIENT(S)

    Fexofenadine HCl USP, 180 mg

  • PURPOSE

    Antihistamine

  • USE(S)

    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 aluminium 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 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 carton is opened or if individual blister units are torn or opened
    • store between 200 and 250C (680 and 770F)
    • protect from excessive moisture and light
  • INACTIVE INGREDIENTS

    anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide

  • QUESTIONS OR COMMENTS?

    call 1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-995-62

    Non-Drowsy
    Original Prescription Strength

    Fexofenadine HCl Tablets USP,
    180 mg/Antihistamine

    Allergy Relief

    Indoor and Outdoor Allergies
    Relief of:

    • Sneezing
    • Runny nose
    • Itchy, watery eyes
    • Itchy nose or throat                                                                    180 mg EACH  15 TABLETS

    fexo-180mg
  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-995
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorORANGE (Peach) Scoreno score
    ShapeCAPSULE (Bevel Edge, Biconvex) Size17mm
    FlavorImprint Code E;44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-995-623 in 1 CARTON09/30/2015
    1NDC:49035-995-605 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20203909/30/2015
    Labeler - Wal-Mart Stores, Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurolife Pharma, LLC829084461MANUFACTURE(49035-995)
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