Label: ALLERGY RELIEF- fexofenadine hcl capsule, coated

  • NDC Code(s): 69168-413-03, 69168-413-06, 69168-413-30
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 23, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient(s)

    Fexofenadine HCl 180 mg

  • Purpose

    Antihistamine

  • Use(s)

    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

    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 caplet with water, once a 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

    • protect from excessive moisture
    • do not use if imprinted seal under safety cap is broken or missing [for bottle]
    • do not use if blister unit is torn or open [for blister]
  • Storage

    store at room temperature 20°– 25°C (68°– 77°F)

  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, ferrosoferric oxide (black iron oxide),
    hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate,
    microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide

  • Questions

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

  • Principal Display Panel

    Allergy Relief

    Allergy Relief

    Fexofenadine

    Fexofenadine


  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    fexofenadine hcl capsule, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-413
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScorescore with uneven pieces
    ShapeCAPSULESize18mm
    FlavorImprint Code G6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-413-033 in 1 CARTON; Type 0: Not a Combination Product03/22/2021
    2NDC:69168-413-06120 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2021
    3NDC:69168-413-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107503/22/2021
    Labeler - Allegiant Health (079501930)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!