Label: ALLERGY RELIEF- fexofenadine hcl tablet, coated

  • NDC Code(s): 21130-064-15, 21130-064-30
  • Packager: Safeway, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 19, 2020

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

  • 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 right away (1-800-222-1222).

  • 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 printed safety sealed under cap is missing or broken or if individual blister units are torn or opened
    • store between 20º and 25ºC (68º and 77ºF)
    • protect from excessive moisture


  • Inactive ingredients

    colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide

  • Questions or comments?

    call 1-888-723-3929 Monday- Friday 7AM- 6PM PST

  • Principal Display Panel

    COMPARE TO Allegra® Allergy 24 Hr active ingredient*

    24 Hour | Original Prescription Strength

    Allergy Relief

    FEXOFENADINE HCL USP 180 mg

    Antihistamine Tablets

    • Relief of: Runny nose, sneezing, itchy nose or throat, itchy & watery eyes
    • For indoor and 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

    BETTER LIVING BRANDS LLC

    P.O. BOX 99, PLEASANTON, CA 94566-0009

    www.betterlivingbrandsLLC.com

  • Product Label

    Fexofenadine HCL USP 180 mg

    SIGNATURE CARE Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    fexofenadine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-064
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code J;44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-064-1515 in 1 CARTON10/01/2019
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:21130-064-301 in 1 BOX10/01/2019
    230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20409710/01/2019
    Labeler - Safeway, Inc. (009137209)