Label: 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.

View All Sections
  • Active ingredient(s)

    Fexofenadine HCl USP, 180 mg

    Pseudoephedrine HCl USP, 240 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 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)
    • 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 24 hours on an empty stomach; do not take more than 1 tablet 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° - 25°C (68° - 77°F)
    • this product meets the requirements of USP Dissolution Test 4
  • 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.

  • Questions?

    Call 1-888-375-3784

    Manufactured by:

    Dr. Reddy’s Laboratories Limited

    Bachupally - 500 090 INDIA.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

    Blister carton label : 10's

    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:55111-557
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE240 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code RDY;572
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55111-557-071 in 1 CARTON08/24/2011
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:55111-557-352 in 1 CARTON08/24/2011
    25 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:55111-557-293 in 1 CARTON08/24/2011
    35 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07904308/24/2011
    Labeler - Dr.Reddy's Laboratories Limited (650562841)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr.Reddy's Laboratories Limted (FTO III)918608162analysis(55111-557) , manufacture(55111-557)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!