Label: FEXOFENADINE HYDROCHLORIDE tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 16, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Fexofenadine HCl USP 180 mg

  • INACTIVE INGREDIENT

    anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregalatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, yellow iron oxide

  • DOSAGE & ADMINISTRATION

    • adults & 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
  • INDICATIONS & USAGE

    temporarily relieves these symptoms due to hay fever or other 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

    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

    Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    Overdose Warning: Taking more than directed can cause serious health problems. Incase of overdose, get medical help or contact a Poison Control Center right away.

  • PURPOSE

    Antihistamine

  • OTHER SAFETY INFORMATION

    • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
    • protect from excessive moisture
    • each tablet contains: sodium 8.2 mg
    • this product meets the requirements of USP Dissolution Test 2

    Tamper Evident: Do not use if package is opened or if blister unite is torn broken or shows any signs of tampering.

  • PRINCIPAL DISPLAY PANEL

    CT13429

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-134
    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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code SG;202
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-134-293 in 1 BLISTER PACK; Type 0: Not a Combination Product07/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107507/22/2019
    Labeler - Strive Pharmaceuticals Inc (080028013)