Label: FEXOFENADINE HCL tablet

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

Drug Label Information

Updated December 16, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient (in each tablet)

    Fexofenadine HCl USP, 60 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    ■ runny nose ■ itchy, watery eyes ■ sneezing ■ 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.

  • 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 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

  • Other information

    ■ safety sealed: do not use if carton is opened or if individual blister units are torn or opened ■ store between 20° and 25°C (68° and 77°F) ■ protect from excessive moisture

  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose
    monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide

  • Questions or comments?

    contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

  • PDP

    Fexo 60mg

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HCL 
    fexofenadine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9765
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    Colororange ((PEACH)) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code G5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9765-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product02/27/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107502/27/2024
    Labeler - Walgreens (008965063)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!