Label: FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI- fexofenadine hcl and pseudoephedrine hci tablet, extended release

  • NDC Code(s): 0363-0448-14, 0363-0448-31
  • Packager: Walgreens Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 4, 2015

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

  • Active ingredient(s)

    Fexofenadine HCl USP, 60 mg

    Pseudoephedrine HCl USP,120 mg

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  • Purpose

    Antihistamine

    Nasal decongestant

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  • Use(s)

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • nasal congestion
    • itchy, watery eyes
    • itching of the nose or throat
    • reduces swelling of nasal passages
    • temporarily relieves sinus congestion and pressure
    • temporarily restores freer breathing through the nose
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  • 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 takeas 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

    Pregnancy/Breastfeeding

    ask a health professional before use.

    Keep out of reach of children

    In case of overdose, get medical help or contacta Poison Control Center right away.

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  • 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

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  • Other information

    • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
    • this product meets the requirements of USP dissolution test 3.
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  • Storage

    • store between 20° to 25°C (68° to 77°F)
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  • Inactive ingredients

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

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  • Questions or comments?

    call toll-free 1-888-375-3784

    Manufactured by:

    Dr. Reddy’s Laboratories Limited

    Bachupally - 500 090 INDIA

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  • Principal Display Panel

    cartonBlister carton 30's (6x5 unit-dose)

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  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI 
    fexofenadine hcl and pseudoephedrine hci tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0448
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 60 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color WHITE (off white to pale yellow one layer and light red to red other layer) Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code R;195
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0448-31 6 in 1 CARTON
    1 5 in 1 BLISTER PACK; Type 6: Drug/Biologic Combination
    2 NDC:0363-0448-14 4 in 1 CARTON
    2 5 in 1 BLISTER PACK; Type 6: Drug/Biologic Combination
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076667 07/17/2015
    Labeler - Walgreens Company (008965063)
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