Label: ALLEGRA ALLERGY- fexofenadine hydrochloride tablet, film coated

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

Drug Label Information

Updated April 14, 2022

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Fexofenadine HCl 180 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. 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 agedo not use
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask a doctor
  • Other information

    • safety sealed: do not use if the individual blister unit is 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 blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

  • Questions or comments?

    call toll-free 1-800-633-1610 or www.allegra.com

  • SPL UNCLASSIFIED SECTION

    Product Repackaged and Distributed
    with permission of manufacturer by:
    Select Corporation Carrollton, TX 75007

  • PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Blister Pack

    Allegra®
    ALLERGY
    fexofenadine HCl tablet
    180 mg/antihistamine
    24HR

    NON-DROWSY

    INDOOR / OUTDOOR
    ALLERGY RELIEF

    2111920120.A

    ✓
    Sneezing
    ✓
    Runny Nose
    ✓
    Itchy, Watery Eyes
    ✓
    Itchy Nose or Throat

    1 TABLET
    Actual Size

    PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Blister Pack
  • INGREDIENTS AND APPEARANCE
    ALLEGRA ALLERGY 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-190(NDC:41167-4131)
    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)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    brown iron oxide (UNII: 1N032N7MFO)  
    Product Characteristics
    ColorORANGE (peach) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 06;E
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-190-031 in 1 BLISTER PACK12/08/2021
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02087212/08/2021
    Labeler - Select Corporation (053805599)
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!