Label: ALLERGY RELIEF NON DROWSY- fexofenadine hcl tablet, coated

  • NDC Code(s): 41250-506-15, 41250-506-30, 41250-506-45, 41250-506-90
  • Packager: MEIJER, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 2, 2023

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  • Active ingredient (in each film-coated 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.

  • 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

    • each tablet contains: sodium 8 mg
    • store between 20-25ºC (68-77ºF)
    • protect from excessive moisture
    • this product meets the requirements of USP Dissolution Test 2
  • Inactive ingredients

    anhydrous lactose,colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide

  • Questions or comments?

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

  • Principal Display Panel

    COMPARE TO ALLEGRA® ALLERGY 24 HOUR ACTIVE INGREDIENT***

    NON-DROWSY

    24 HOUR RELIEF

    SNEEZING; RUNNY NOSE; ITCHY WATERY EYES; ITCHY THROAT OR NOSE

    Fexofenadine HCI Caplets | 180 mg | Antihistamine

    Indoor & Outdoor Allergies

    Original Prescription Strength

    PRESCRIPTION STRENGTH

    COATED 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.

    DIST. BY MEIJER

    DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

  • Product Label

    Fexofenadine HCl USP 180 mg

    MEIJER Non-Drowsy Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF  NON DROWSY
    fexofenadine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-506
    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)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code SG;202
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-506-301 in 1 CARTON03/31/2018
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:41250-506-1515 in 1 CARTON03/31/2018
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41250-506-451 in 1 CARTON03/31/2018
    345 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:41250-506-901 in 1 CARTON03/31/2018
    490 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20450703/31/2018
    Labeler - MEIJER, INC. (006959555)
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