Label: ALLERGY RELIEF tablet

  • NDC Code(s): 69168-450-80, 69168-450-82
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 17, 2024

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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

    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

    if an allergic reaction to this product occurs. Seek medical help right away.

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of reach of children

    In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults and children 12 years of age: take one 180 mg caplet with water, once a and over day; do not take more than 1 caplet 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 at room temperature 20°– 25°C (68°– 77°F)
    • protect from excessive moisture
    • do not use if imprinted seal under safety cap is broken or missing
  • 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/Comments

    Call 1-888-952-0050 Monday through Friday 9AM - 5PM

  • Principal Display Panel

    Allergy Relief

    Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    allergy relief tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-450
    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, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 44;J
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-450-80180 in 1 BOTTLE; Type 0: Not a Combination Product04/17/2024
    2NDC:69168-450-8290 in 1 BOTTLE; Type 0: Not a Combination Product04/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20409704/17/2024
    Labeler - Allegiant Health (079501930)
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