Label: ALLERGY RELIEF- fexofenadine hydrochloride tablet

  • NDC Code(s): 36800-653-03, 36800-653-06, 36800-653-07, 36800-653-11, view more
    36800-653-14, 36800-653-16
  • Packager: TOPCO ASSOCIATES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • WARNINGS

    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

    • store between 20-25°C (68-77°F)
    • protect from excessive moisture
    • retain carton for complete product information and warnings
  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    TopCare® health

    NDC 36800-653-03

    COMPARE TO ALLEGRA® ALLERGY ACTIVE INGREDIENT*

    NON-DROWSY

    Allergy Relief

    FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg (ANTIHISTAMINE)

    24 HR

    INDOOR/OUTDOOR ALLERGY RELIEF

    • Sneezing

    • Runny Nose

    • Itchy, Watery Eyes

    • Itchy Nose or Throat

    15 TABLETS

    actual size

    image description

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-653
    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)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange ((PEACH)) Scoreno score
    ShapeOVAL (Capsule-shaped) Size17mm
    FlavorImprint Code G6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-653-031 in 1 CARTON09/10/2021
    115 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:36800-653-162 in 1 CARTON08/31/202106/30/2025
    230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:36800-653-14180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/202106/30/2025
    4NDC:36800-653-061 in 1 CARTON11/16/202111/30/2023
    445 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:36800-653-071 in 1 CARTON12/08/2022
    560 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:36800-653-111 in 1 CARTON12/08/2023
    6150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107508/31/2021
    Labeler - TOPCO ASSOCIATES LLC (006935977)
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