Label: ALLERGY RELIEF- fexofenadine hcl capsule, coated

  • NDC Code(s): 69168-416-03, 69168-416-06, 69168-416-30
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 27, 2020

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  • Active ingredient (in each tablet)

    Fexofenadine HCl 180mg

  • 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

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

    Pregnancy/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 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 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

    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

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

  • Principal Display Panel

    Allergy Relief

    Allergy Relief


  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    fexofenadine hcl capsule, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-416
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code SG;202
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-416-06120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/14/2020
    2NDC:69168-416-033 in 1 CARTON; Type 0: Not a Combination Product08/14/2020
    3NDC:69168-416-3030 in 1 BOTTLE; Type 0: Not a Combination Product08/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20450712/26/2014
    Labeler - Allegiant Health (079501930)
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