Label: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE tablet, film coated, extended release

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 28, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each extended-release tablet)Purpose
    Fexofenadine HCl, USP 60 mgAntihistamine
    Pseudoephedrine HCl, USP 120 mgNasal Decongestant
  • Uses

    • 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)

    Stop use and ask a 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 (1800-222-1222).

  • Directions

    • do not divide, crush, chew or dissolve the tablet; swallow tablet whole
    adults and children 12 years of age and overtake 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

    • 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)
    • USP dissolution test is pending.
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethyl cellulose, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid.

  • Questions or comments?

    Call toll-free 1-800-818-4555 weekdays

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    AmerisourceBergen
    1 West First Avenue
    Conshohocken, PA 19428

  • PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

    Compare to Allegra-D® active ingredients**

    Rx
    GOOD
    NEIGHBOR
    PHARMACY®

    NDC 46122-694-65

    Original Prescription Strength

    NON-DROWSY
    12 HOUR

    fexofenadine HCl 60 mg/antihistamine
    pseudoephedrine HCl 120 mg/nasal decongestant
    Extended-Release Tablets, USP

    Indoor & Outdoor Allergies

    Allergy & Congestion

    Relief of:

    • Nasal and Sinus Congestion Due to Colds or Allergies
    • Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or
      Throat Due to Allergies

    30 Extended-Release Tablets

    PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
    fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-694
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITE, YELLOWScoreno score
    ShapeCAPSULE (bilayer) Size17mm
    FlavorImprint Code 724
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-694-653 in 1 CARTON03/01/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09081803/01/2018
    Labeler - AmeriSource Bergen (007914906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited650445203ANALYSIS(46122-694) , MANUFACTURE(46122-694)
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