Label: FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI tablet, extended release

  • NDC Code(s): 43598-823-14, 43598-823-31, 43598-823-35
  • Packager: Dr. Reddy's Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 9, 2019

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  • 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)
    • this product meets the requirements of USP dissolution test 3.
  • Inactive ingredients

    corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose and triethyl citrate.

  • Questions?

    Call 1-888-375-3784

    Distributed by:

    Dr. Reddy’s Laboratories, Inc.

    Princeton, NJ 08540

    Made in India

  • Principal Display Panel

    Blister carton

    carton

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI 
    fexofenadine hcl and pseudoephedrine hci tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-823
    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
    MANNITOL (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorWHITE (buff white to pale yellow color and other layer light red to red color) Scoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code R;195
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43598-823-144 in 1 CARTON07/18/2019
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:43598-823-316 in 1 CARTON07/18/2019
    25 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:43598-823-352 in 1 CARTON10/31/2019
    35 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07666707/18/2019
    Labeler - Dr. Reddy's Laboratories Inc. (802315887)
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