Label: FEX-ALLERGY RELIEF- fexofenadine hcl tablet

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

Drug Label Information

Updated September 29, 2020

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

View All Sections
  • Active Ingredient

    Fexofenadine hydrochloride USP, 180 mg

  • Purpose

    Antihistamine

  • Uses:

    • 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
  • Do not use:

    Do not use

    if you have ever had an allergic reaction to this product or any of its ingredients.

  • 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)
  • ASK A DOCTOR BEFORE USE IF

    Kidney disease. Your doctor should determine if you need a different dose.

  • STOP USE AND ASK A DOCTOR IF

    an allergic reaction to this product occurs. Seek medical help right away.

  • If pregnant or breast-feeding

    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 tablets in 24 hours.
    children under 12 years of agedo not use
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask a doctor

  • OTHER INFORMATION

    • store at 20°-25°C (68°-77°F)
    • protect from excessive moisture
    • this product meets the requirement of USP dissolution test 2.

  • INACTIVE INGREDIENTS

    colloidal silicon dioxide, corn starch,croscarmellose sodium, magnesium stearate,mannitol and microcrystalline cellulose, opadry pink 03B54504 containing FD and C red No.40, iron oxide black,hypromellose,polyethylene glycol, titanium dioxide.

  • QUESTIONS OR COMMENTS?

    Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

  • 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 (1-800-222-1222) right away.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    FEX-ALLERGY RELIEF 
    fexofenadine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-061
    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
    MANNITOL (UNII: 3OWL53L36A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code J;44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-061-9090 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20409709/21/2020
    Labeler - Pioneer Life Sciences, LLC (014092742)
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!