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

  • NDC Code(s): 55111-557-07, 55111-557-29, 55111-557-35
  • Packager: Dr.Reddy's Laboratories Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 5, 2018

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

  • Active ingredient(s)

    Fexofenadine HCl USP, 180 mg

    Pseudoephedrine HCl USP, 240 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
    • 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
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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 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.

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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 24 hours on an empty stomach; do not take more than 1 tablet 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
    • store between 20° - 25°C (68° - 77°F)
    • this product meets the requirements of USP Dissolution Test 4
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  • Inactive ingredients

    acetyltributyl citrate, colloidal silicon dioxide, copovidone, croscarmellose sodium, ethylcellulose, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide.

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  • Questions?

    Call 1-888-375-3784

    Manufactured by:

    Dr. Reddy’s Laboratories Limited

    Bachupally - 500 090 INDIA.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

    Blister carton label : 10's

    carton

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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:55111-557
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 180 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 240 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    COPOVIDONE (UNII: D9C330MD8B)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 21mm
    Flavor Imprint Code RDY;572
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55111-557-07 1 in 1 CARTON 08/24/2011
    1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:55111-557-35 2 in 1 CARTON 08/24/2011
    2 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:55111-557-29 3 in 1 CARTON 08/24/2011
    3 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079043 08/24/2011
    Labeler - Dr.Reddy's Laboratories Limited (650562841)
    Establishment
    Name Address ID/FEI Business Operations
    Dr.Reddy's Laboratories Limted (FTO III) 918608162 analysis(55111-557) , manufacture(55111-557)
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