Label: BERKLEY JENSEN ALLERGY RELIEF- fexofenadine hydrochloride tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 27, 2023

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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 package is opened or printed foil under cap is broken or missing
    •
    store between 20°-25°C (68°-77°F)
    •
    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

  • Questions or comments?

    1-800-934-1204

  • Principal Display Panel - Label

    berkley jensen®

    24 HR

    NON-DROWSY

    ALLERGY RELIEF

    FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg

    ANTIHISTAMINE

    24 HOUR

    INDOOR/OUTDOOR ALLERGY RELIEF

    SNEEZING ● RUNNY NOSE

    ITCHY, WATERY EYES ● ITCHY NOSE OR THROAT

    150 TABLETS | 180mg EACH

    allergy relief label
  • Principal Display Panel - Package

    Compare to the active ingredient in Allegra® Allergy 24 HR

    berkley jensen®

    24 HR

    NON-DROWSY

    ALLERGY RELIEF

    FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg

    ANTIHISTAMINE

    24 HOUR

    INDOOR/OUTDOOR

    ALLERGY RELIEF

    • SNEEZING

    • RUNNY NOSE

    • ITCHY, WATERY EYES

    • ITCHY NOSE OR THROAT

    ACTUAL SIZE

    100% MONEY-BACK GUARANTEE

    150 TABLETS 180mg EACH

    allergy relief package image 1
    allergy relief package image 2
  • INGREDIENTS AND APPEARANCE
    BERKLEY JENSEN ALLERGY RELIEF 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-847
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    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:68391-847-471 in 1 CARTON02/27/2022
    1150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21297102/27/2022
    Labeler - BJWC (159082692)
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