Label: ALLEGRA ALLERGY- fexofenadine hydrochloride tablet

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

Drug Label Information

Updated September 23, 2016

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

  • 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 desease. 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 over  take one 180mg 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

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

    colloidal silicone 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

  • Package Labeling:

    Allegra Allergy

  • INGREDIENTS AND APPEARANCE
    ALLEGRA ALLERGY 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-173(NDC:67751-033)
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (peach) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 018
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-173-011 in 1 CARTON09/23/2016
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02087209/23/2016
    Labeler - Navajo Manufacturing Company Inc. (091917799)