Label: ALLERGY RELIEF- fexofenadine hydrochloride tablet

  • NDC Code(s): 57344-192-02, 57344-192-04, 57344-192-06
  • Packager: AAA Pharmaceutical, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 5, 2021

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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

    • each tablet contains: sodium 8.2 mg
    • store between 20-25°C (68-77°F)
    • protect from excessive moisture
    • this product meets the requirements of USP Dissolution Test 2
    • retain carton for complete product information and warnings
  • 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, yellow iron oxide

  • Questions or Comments?

    1-844-705-4384

  • PRINCIPAL DISPLAY PANEL

    RESTORE U

    NDC 57344-192-02

    COMPARE TO THE ACTIVE INGREDIENT IN ALLEGRA® ALLERGY 24 HOUR

    NON-DROWSY

    Allergy Relief

    Fexofenadine Hydrochloride Tablets, 180 mg / Antihistamine

    Indoor and Outdoor Allergies – Original Prescription Strength

    Relieves:  Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Nose or Throat

    24 HR

    Actual Size

    5 TABLETS

    image description

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-192
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVAL (Modified oval shape) Size17mm
    FlavorImprint Code SG;202
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57344-192-021 in 1 CARTON10/01/201810/31/2022
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:57344-192-041 in 1 CARTON06/01/201805/31/2021
    230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:57344-192-061 in 1 CARTON06/01/201802/28/2023
    345 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20450706/01/201802/28/2023
    Labeler - AAA Pharmaceutical, Inc. (181192162)
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