Label: FEXOFENADINE HCL tablet

  • NDC Code(s): 71399-8042-1, 71399-8042-3
  • Packager: Akron Pharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 20, 2024

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  • ACTIVE INGREDIENT(S), in each tablet

    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

    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

    60 mg

    adults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
    children under 12 years of agedo not use
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask a doctor

    180 mg

    adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
    children under 12 years of agedo not use
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask 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

    anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch(maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide titanium dioxide and yellow iron oxide.

  • HOW SUPPLIED SECTION

    Fexofenadine Hydrochloride Tablets, USP 180 mg 30 CT 

    NDC: 71399-8042-3

    Fexofenadine Hydrochloride Tablets, USP 180 mg 100 CT

    NDC: 71399-8042-1

  • QUESTIONS OR COMMENTS

    Call weekdays 8.30 AM to 4.30 PM EST Please Call 1(877) 225-6999

    Manufactured for:
    Akron Pharma, Inc.
    Fairfield, NJ 07004
    Manufactured in U.S.A

  • PRINCIPAL DISPLAY PANEL

    30CT

    100CT

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HCL 
    fexofenadine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-8042
    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
    ShapeCAPSULESize18mm
    FlavorImprint Code SG;202
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-8042-330 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2024
    2NDC:71399-8042-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20450709/09/2020
    Labeler - Akron Pharma Inc. (067878881)
    Establishment
    NameAddressID/FEIBusiness Operations
    ScieGen Pharmaceuticals LLC079391286manufacture(71399-8042)
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