Label: CHILDRENS ALLEGRA ALLERGY- fexofenadine hydrochloride tablet, orally disintegrating

  • NDC Code(s): 41167-4232-1, 41167-4232-6
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated August 29, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (in each tablet)

    Fexofenadine HCI 30 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itchy, water 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 (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

    • place 1 tablet on tongue; tablet disintegrates, with or without water
    adults and children 12 years of age and overtake 2 tablets every 12 hours on an empty stomach; do not take more than 4 tablets in 24 hours
    children 6 to under 12 years of agetake 1 tablet every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
    children under 6 years of agedo not use
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask a doctor
  • Other information

    • phenylketonurics: contains phenylalanine 3.8 mg per tablet
    • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
    • store between 20º and 25ºC (68º and 77ºF)
    • use tablet immediately after opening individual blister
    • contains lactose
  • Inactive ingredients

    aspartame, crospovidone, flavors, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, silicon dioxide

  • Questions or comments?

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

    Dist. By: Chattem, Inc, a Sanofi Company,

    Chattanooga, TN 37409-0219 ©2015

  • PRINCIPAL DISPLAY PANEL

    NDC 41167-4232-1
    NON-DROWSY
    Children’s
    Allegra    ® 
    Allergy
    fexofenadine HC    l orally disintegrating
    tablet 30     mg/antihistamine
    Indoor and Outdoor Aller    gies
    Orange Cream flavor
    12 Orally Disintegrating Tablets

    PRINCIPAL DISPLAY PANEL NDC 41167-4232-1 NON-DROWSY Children’s Allegra® Allergy fexofenadine HCl orally disintegrating tablet 30 mg/antihistamine Indoor and Outdoor Allergies Orange Cream flavor 12 Orally Disintegrating Tablets

  • PRINCIPAL DISPLAY PANEL

    NDC 41167-4232-6
    NON-DROWSY
    Children’s
    Allegra    ® 
    Allergy
    fexofenadine HC    l orally disintegrating
    tablet 30     mg/antihistamine
    Indoor and Outdoor Aller    gies
    Orange Cream flavor
    24 Orally Disintegrating Tablets

    PRINCIPAL DISPLAY PANEL NDC 41167-4232-6 NON-DROWSY Children’s Allegra® Allergy fexofenadine HCl orally disintegrating tablet 30 mg/antihistamine Indoor and Outdoor Allergies Orange Cream flavor 24 Orally Disintegrating Tablets

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLEGRA ALLERGY 
    fexofenadine hydrochloride tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4232
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorORANGE (Orange Cream) Imprint Code e;311;AV
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-4232-12 in 1 CARTON01/02/2014
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-4232-64 in 1 CARTON01/02/2014
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02190901/02/2014
    Labeler - Chattem, Inc. (003336013)
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