Label: ALLERGY RELIEF- fexofenadine hcl tablet, coated

  • NDC Code(s): 59726-801-03, 59726-801-12, 59726-801-15, 59726-801-30, view more
    59726-801-70
  • Packager: P & L Development, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 16, 2023

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  • Active ingredient (in each  tablet)

    Fexofenadine HCl USP, 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 (1-800-222-1222) right away.

  • 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

    • store between 20-25ºC (68-77ºF)
    • protect from excessive moisture


  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow,  lactose monohydrate, polyethylene glycol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide

  • Questions or comments?

    call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredient in Allegra® Allergy 24 Hour*

    allergy relief

    fexofenadine HCl tablets USP, 180 mg

    antihistamine

    for indoor and outdoor allergies

    non-drowsy

    24 hour relief of

    • runny nose
    • sneezing,
    • itchy, watery eyes
    • itchy nose or throat
    • for indoor & outdoor allergies
    • non-drowsy

    caplets**

    (**capsule-shaped tablets)

    *This product is not manufactured or distributed by Chattem, Inc., distributor of Allegra® Allergy 24 Hour.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by: PL Developments

    200 Hicks Street, Westbury, NY 11590

  • Product Label

    Fexofenadine HCl USP, 180 mg

    READYinCASE Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    fexofenadine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-801
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorpink (Peach) Scoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code G6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59726-801-033 in 1 CARTON08/20/2021
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:59726-801-12120 in 1 CARTON08/20/2021
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:59726-801-1515 in 1 CARTON08/20/2021
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:59726-801-701 in 1 BOX08/20/2021
    470 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:59726-801-301 in 1 BOX08/20/2021
    530 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20450708/20/2021
    Labeler - P & L Development, LLC (800014821)
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