Label: FEXOFENADINE HCL tablet

  • NDC Code(s): 16714-899-01, 16714-899-02
  • Packager: NorthStar RxLLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 30, 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

     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
  • Other information

            • Tamper-Evident: Do not use if printed foil seal under cap is 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?

    Call 1-800-206-7821

    Manufactured for:
    Northstar Rx LLC
    Memphis, TN 38141.

    Manufactured by:
    Hetero Labs Limited,
    Unit V, Polepally, Jadcherla,
    Mahabubnagar - 509 301, India.

    Mfg. Lic. No.: 50/MN/AP/2009/F/R

    Issued: 04/2019

  • PRINCIPAL DISPLAY PANEL


    Fexofenadine Hydrochloride Tablets USP, 180 mg - 30s container label


    fexofenadinehcl30slabel


    Fexofenadine Hydrochloride Tablets USP, 180 mg - 30s container carton


    fexofenadinehcl30scarton


    Fexofenadine Hydrochloride Tablets USP, 180 mg - 100s container label



    fexofenadinehcl100slabel


    Fexofenadine Hydrochloride Tablets USP, 180 mg - 100s container carton



    fexofenadinehcl100scarton

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HCL 
    fexofenadine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16714-899
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    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)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code J;44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16714-899-011 in 1 CARTON02/18/2019
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:16714-899-021 in 1 CARTON02/18/2019
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20409702/18/2019
    Labeler - NorthStar RxLLC (830546433)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hetero Labs Limited Unit V650452530ANALYSIS(16714-899) , MANUFACTURE(16714-899)
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