Label: ALLERGY RELIEF- fexofenadine hydrochloride tablet, film coated

  • NDC Code(s): 56062-847-22, 56062-847-39, 56062-847-95
  • Packager: Publix Super Markets Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 21, 2022

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  • 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 (1-800-222-1222).

  • Directions

    adults and children 12 years of age and over

    take one 180 mg 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

    •
    do not use if printed blister unit is broken or torn
    •
    store between 68° -77°F (20° -25°C)
    •
    protect from excessive moisture
    •
    this product meets the requirements of USP Dissolution Test 2
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

  • Package/Label Principal Display Panel

    P

    24-HR

    allergy relief

    FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg

    ANTIHISTAMINE

    Indoor/outdoor allergy relief

    • Sneezing

    • Runny nose

    • Itchy, watery eyes

    • Itchy nose or throat

    NON-DROWSY

    ACTUAL SIZE

    15 TABLETS

    Compare to Allegra® Allergy active ingredient

    allergy relief image
  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-847
    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)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code L847
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-847-2215 in 1 CARTON01/14/2022
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:56062-847-391 in 1 CARTON01/21/2022
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:56062-847-951 in 1 CARTON01/21/2022
    345 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21297101/14/2022
    Labeler - Publix Super Markets Inc (006922009)
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