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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 13, 2019

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  • Active ingredients

    (in each extended-release 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)
  • Stop use and ask 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 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

    •
    do not use if carton is opened or if individual blister units are torn or opened.
    •
    store between 20° to 25°C (68° to 77°F)
    •
    USP dissolution test is pending.
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethyl cellulose, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid.

  • Questions or comments?

    call toll free 1-800-818-4555 weekdays

  • PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

    NON-DROWSY
    ORIGINAL PRESCRIPTION STRENGTH

    Walgreens

    Wal-Fex® D

    ALLERGY & CONGESTION

    FEXOFENADINE HCl 60 mg / ANTIHISTAMINE
    PSEUDOEPHEDRINE HCl 120 mg / NASAL DECONGESTANT

    12 HOUR
    EXTENDED-RELEASE TABLETS, USP

    INDOOR & OUTDOOR ALLERGIES

    • Nasal and Sinus Congestion Due to Colds or Allergies
    • Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy
      Nose or Throat Due to Allergies

    30
    EXTENDED-RELEASE
    TABLETS

    DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

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

    NDC 0363-2110-30

    12
    HOUR

    ACTUAL SIZE

    PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack 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:0363-2110
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITE, YELLOWScoreno score
    ShapeCAPSULE (bilayer) Size17mm
    FlavorImprint Code 724
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-2110-2020 in 1 BLISTER PACK; Type 0: Not a Combination Product04/17/2018
    2NDC:0363-2110-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product04/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09081804/17/2018
    Labeler - walgreens (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited650445203ANALYSIS(0363-2110) , MANUFACTURE(0363-2110)
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