Label: ALLEGRA HIVES 24HR- fexofenadine hydrochloride tablet, film coated

  • NDC Code(s): 41167-4126-3, 41167-4126-4, 41167-4126-8
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 13, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Allegra Hives 24HR tablet 180 mg

    Drug Facts

  • Active ingredient (in each tablet)

    Fexofenadine HCl 180 mg

  • Purpose

    Antihistamine

  • Uses

    reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

  • Warnings

    Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

    ■ trouble swallowing ■ dizziness or loss of consciousness ■ swelling of tongue 

    ■ swelling in or around mouth ■ trouble speaking ■ wheezing or problems breathing ■ drooling

    These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

    Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

    Do not use

    ■ to prevent hives from any known cause such as:

    ■ foods ■ insect stings ■ medicines ■ latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

    ■ 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.

    ■ hives that are an unusual color, look bruised or blistered

    ■ hives that do not itch

    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.

    ■ symptoms do not improve after 3 days of treatment

    ■ the hives have lasted more than 6 weeks

    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

    ■(if blister) safety sealed: do not use if carton is opened or if individual blister units are torn or opened

    ■(on the carton if bottle) safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing

    ■(if bottle) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing

    ■ 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

  • PRINCIPAL DISPLAY PANEL

    Allegra
    Hives
    fexofenadine HCI tablet
    180 mg/antihistamine
    24 HR
    5 TABLETS

    Allegra
Hives
fexofenadine HCI tablet
180 mg/antihistamine
24 HR
5 TABLETS

  • PRINCIPAL DISPLAY PANEL

    Allegra
    Hives
    fexofenadine HCI tablet
    180 mg/antihistamine
    24 HR
    30 TABLETS

    Allegra
Hives
fexofenadine HCI tablet
180 mg/antihistamine
24 HR
30 TABLETS

  • INGREDIENTS AND APPEARANCE
    ALLEGRA HIVES 24HR 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4126
    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)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (peach) Scoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 018;E
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-4126-81 in 1 CARTON06/06/2022
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-4126-31 in 1 CARTON06/06/2022
    215 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:41167-4126-41 in 1 CARTON06/06/2022
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02087206/06/2022
    Labeler - Chattem, Inc. (003336013)