Label: FEXOFENADINE HCL tablet

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

Drug Label Information

Updated June 11, 2019

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  • ACTIVE INGREDIENT(S), in each tablet

    Fexofenadine hydrochloride 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 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

    60 mg


    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
    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


    180 mg


    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 printed foil inner seal on the bottle is torn or missing.
    •  store between 20° and 25°C (68° and 77°F)
    •  protect from excessive moisture

  • INACTIVE INGREDIENTS

    Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

  • QUESTIONS OR COMMENTS

    call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418

  • Fexofenadine Hcl 180mg Tablet

    Label Image
  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HCL 
    fexofenadine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1217(NDC:69230-300)
    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)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code J;44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1217-130 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2019
    2NDC:71335-1217-215 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2019
    3NDC:71335-1217-360 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2019
    4NDC:71335-1217-490 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2019
    5NDC:71335-1217-55 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2019
    6NDC:71335-1217-6180 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2019
    7NDC:71335-1217-7100 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20409708/19/2016
    Labeler - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1217) , RELABEL(71335-1217)
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