Label: FEXOFENADINE HCL tablet

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

Drug Label Information

Updated August 1, 2023

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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?

    Repackaged and Distributed By:

    Remedy Repack, Inc.

    625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

  • PRINCIPAL DISPLAY PANEL

    DRUG: Fexofenadine HCL

    GENERIC: Fexofenadine HCL

    DOSAGE: TABLET

    ADMINSTRATION: ORAL

    NDC: 70518-3789-0

    COLOR: pink

    SHAPE: CAPSULE

    SCORE: No score

    SIZE: 18 mm

    IMPRINT: J;44

    PACKAGING: 30 in 1 BOTTLE, PLASTIC

    ACTIVE INGREDIENT(S):

    • FEXOFENADINE HYDROCHLORIDE 180mg in 1

    INACTIVE INGREDIENT(S):

    • SILICON DIOXIDE
    • HYPROMELLOSE 2910 (6 MPA.S)
    • LIGHT MINERAL OIL
    • MAGNESIUM STEARATE
    • CELLULOSE, MICROCRYSTALLINE
    • POLYETHYLENE GLYCOL 6000
    • POLYSORBATE 80
    • STARCH, CORN
    • FERRIC OXIDE RED
    • FERRIC OXIDE YELLOW
    • SODIUM STARCH GLYCOLATE TYPE A POTATO
    • TALC
    • TITANIUM DIOXIDE

    Remedy_Label

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HCL 
    fexofenadine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-3789(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:70518-3789-030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20409707/13/2023
    Labeler - REMEDYREPACK INC. (829572556)
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