Label: EQUATE ALLERGY RELIEF- fexofenadine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 19, 2023

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  • Active ingredient(s)

    Fexofenadine hydrochloride USP, 180 mg

  • Purpose

    Antihistamine

  • Use(s)

    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

    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

    Ask a doctor or pharmacist 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 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

    • Safety Sealed: do not use if carton is opened or if printed foil inner seal on the bottle is torn or missing.
    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
  • Inactive ingredients

    Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

  • Questions

    call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418

  • Principal Display Panel

    Fexofenadine Hydrochloride Tablets, USP 180 mg 30 ct Container Label

    Principal Display Panel

    Fexofenadine Hydrochloride Tablets, USP 180 mg 30ct Carton Label

    Principal Display Panel

    Fexofenadine Hydrochloride Tablets, USP 180 mg 2x30 ct Carton Label

    Principal Display Panel

    Fexofenadine Hydrochloride Tablets, USP 180 mg 120 ct Carton Label

    Principal Display PanelPrincipal Display Panel

  • INGREDIENTS AND APPEARANCE
    EQUATE ALLERGY RELIEF 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-366(NDC:69230-300)
    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)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code J;44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-366-541 in 1 CARTON04/14/2011
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49035-366-592 in 1 CARTON04/14/2011
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:49035-366-021 in 1 CARTON04/14/2011
    3120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20409704/14/2011
    Labeler - Walmart Inc. (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Legacy Pharmaceutical Packaging, LLC143213275repack(49035-366) , relabel(49035-366)
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