Label: ALLEGRA ALLERGY- fexofenadine hydrochloride tablet, coated

  • NDC Code(s): 41167-4122-0, 41167-4122-2, 41167-4122-5, 41167-4122-6, view more
    41167-4122-7, 41167-4122-9
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated August 30, 2021

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

  • SPL UNCLASSIFIED SECTION

    Allegra Allergy® Gelcaps  24 HOUR

    Drug Facts

  • Active ingredient

    (in each tablet)

    Fexofenadine HCI 180 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

    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 carton is opened or if individual blister units are torn or opened
    • store between 20º and 25ºC (68º and 77ºF) 
    • protect from excessive moisture
  • Inactive ingredients

    croscarmellose sodium, D&C red 28, D&C red 33, FD&C blue 1, gelatin, hydroxypropylcellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, PEG-135, pharmaceutical ink, pregelatinized starch, titanium dioxide

  • Questions or comments?

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

    The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection.
    Dist. By: Chattem, Inc., a Sanofi Company, Chattanooga, TN 37409-0219 ©2014

  • PRINCIPAL DISPLAY PANEL

    NDC 41167-4122-0
    Allegra® 
    ALLERGY
    fexofenadine HCI tablet
    180 mg/antihistamine
    24 HR
    8 GELCAPS 

    NDC 41167-4122-0
Allegra® 
ALLERGY
fexofenadine HCI tablet
180 mg/antihistamine
24 HR
8 GELCAPS

  • INGREDIENTS AND APPEARANCE
    ALLEGRA ALLERGY 
    fexofenadine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4122
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorpurple (White band in the middle) Scoreno score
    ShapeOVAL (Caplet) Size20mm
    FlavorImprint Code AG;AG
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-4122-51 in 1 CARTON12/17/2014
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41167-4122-61 in 1 CARTON12/17/2014
    232 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:41167-4122-92 in 1 CARTON12/17/201406/23/2019
    3NDC:41167-4122-740 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:41167-4122-21 in 1 CARTON12/17/2014
    460 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:41167-4122-01 in 1 CARTON12/17/2014
    58 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02087212/17/2014
    Labeler - Chattem, Inc. (003336013)