Label: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE tablet, film coated, extended release

  • NDC Code(s): 0363-0094-67, 0363-0094-84
  • Packager: WALGREEN CO.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 12, 2021

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

  • Drug Facts

    Active ingredients (in each tablet)

    Fexofenadine HCl USP 60 mg
    Pseudoephedrine HCl USP 120 mg

  • Purpose

    Antihistamine
    Nasal decongestant

  • 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
    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • reduces swelling of nasal passages
    • temporarily relieves sinus congestion and pressure
    • temporarily restores freer breathing through the nose
  • Warnings

    Do not use

    • if you have ever had an allergic reaction to this product or any of its ingredients
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
    • if you have difficulty swallowing
  • Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • glaucoma
    • high blood pressure
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • 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)
    • the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).
  • Stop use and ask a doctor if

    • an allergic reaction to this product occurs. Seek medical help right away.
    • symptoms do not improve within 7 days or are accompanied by a fever
    • you get nervous, dizzy, or sleepless

    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 (1-800-222-1222) right away.

  • Directions

    • do not divide, crush, chew or dissolve the tablet; swallow tablet whole

     adults and children 12 years of age and over
     take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets 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

    • safety sealed: do not use if carton is opened or if individual blister units are torn or opened. 
    • store at 20-25°C (68-77°F).
    • Meets USP dissolution test 7
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid

    Questions or Comments?

    call 1-855-274-4122

    IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information.

    DISTRIBUTED BY:
    WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    walgreens.com
    ©2021 Walgreen Co.
    MADE IN INDIA

    Code: TS/DRUGS/22/2009

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton

    Walgreens

    Compare to the active ingredients in
    Allegra-D® 12 Hour
    Allergy & Congestion Tablets††

    NDC 0363-0094-67

    NON-DROWSY
    Allergy Relief D12
    ALLERGY & CONGESTION

    Fexofenadine HCl USP 60 mg / Antihistamine
    Pseudoephedrine HCl USP 120 mg / Nasal decongestant

    12 HOUR
    Extended-Release Tablets USP

    Indoor & Outdoor Allergies

    • Nasal and sinus congestion due to colds or allergies
    • Relief of sneezing; runny nose; itchy, watery eyes
      and itchy nose or throat due to allergies    


    20 EXTENDED-RELEASE TABLETS

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton




  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
    fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0094
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorYELLOW (White to Off White Layer and Yellow to Pale Yellow) Scoreno score
    ShapeCAPSULE (Bincovex) Size19mm
    FlavorImprint Code Z;79
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0094-672 in 1 CARTON10/30/2017
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0094-843 in 1 CARTON10/30/2017
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20911610/30/2017
    Labeler - WALGREEN CO. (008965063)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(0363-0094) , MANUFACTURE(0363-0094)