Label: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE tablet, extended release

  • NDC Code(s): 51316-015-20, 51316-015-30
  • Packager: CVS Health Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 12, 2022

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

  • Active ingredient(s)

    Fexofenadine HCl USP, 60 mg

    Pseudoephedrine HCl USP, 120 mg

  • Purpose

    Antihistamine

    Nasal decongestant

  • 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
    • temporarily relives 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 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 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 individual blister units are torn or opened
    • store between 20° to 25°C (68° to 77°F) store between 20° to 25°C (68° to 77°F)
    • FDA approved dissolution test specifications differ from USP.
    • FDA approved organic impurities test procedure differs from USP Procedure 1.
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, ferric oxide (iron oxide yellow), HPMC 2910 / hypromellose (6 Cps), hydroxypropyl cellulose, hypromellose (methocel K100M DC2), macrogol (polyethylene glycol MW 400), macrogol (polyethylene glycol MW 8000), magnesium stearate, microcrystalline cellulose (avicel PH 101), microcrystalline cellulose (avicel PH102), pregelatinized starch.

  • Questions?

    Call 1-888-375-3784

  • Principal Display Panel

    Blister carton

    Carton

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
    fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-015
    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
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Hypromellose 2208 (100000 Mpa.S) (UNII: VM7F0B23ZI)  
    HYDROXYPROPYL CELLULOSE (45000 WAMW) (UNII: 8VAB711C5E)  
    Hypromellose 2910 (6 Mpa.S) (UNII: 0WZ8WG20P6)  
    Polyethylene Glycol 8000 (UNII: Q662QK8M3B)  
    Starch, Corn (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    Product Characteristics
    ColorWHITE (one white to off-white color layer and other light yellow to yellow color) Scoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-015-204 in 1 CARTON03/17/2023
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:51316-015-306 in 1 CARTON03/17/2023
    25 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21543406/03/2022
    Labeler - CVS Health Corp (062312574)