Label: ALLEGRA-D ALLERGY AND CONGESTION- fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release

  • NDC Code(s): 41167-4320-3, 41167-4320-5, 41167-4320-7
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 3, 2011

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    (in each tablet)

    Fexofenadine HCl 180 mg

  • Purpose

    Antihistamine

  • Active ingredients

    (in each tablet)

    Pseudoephedrine HCl 240 mg

  • Purpose

    Nasal 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)
    • the tablet coating may be seen in the stool (this is normal). Continue to take as directed (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.

  • 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

    • each tablet contains: sodium 33 mg
    • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
    • store between 20º and 25ºC (68º and 77ºF)
  • Inactive ingredients

    acetone, black iron oxide, cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, glycerol triacetate, hypromellose, isopropyl alcohol, magnesium stearate, methyl alcohol, methylene chloride, microcrystalline cellulose, polyethylene glycol, propylene glycol, povidone, sodium chloride, talc, titanium dioxide, water

  • Questions or comments?

    call toll-free 1-800-633-1610 or www.allegra.com

  • PRINCIPAL DISPLAY PANEL

    NDC 41167-4320-7
    NON-DROWSY
    Allegra-D®
    ALLERGY & CONGESTION
    fexofenadine HCl 180 mg/antihistamine
    pseudoephedrine HCl 240 mg/nasal decongestant
    Extended Release Tablets
    15 Tablets

    PRINCIPAL DISPLAY PANEL
NDC 41167-4320-7
NON-DROWSY
Allegra-D®
ALLERGY & CONGESTION
fexofenadine HCi 180 mg/antihistamine
pseudoephedrine HCi 240 mg/nasal decongestant
Extended Release Tablets
15 Tablets

  • INGREDIENTS AND APPEARANCE
    ALLEGRA-D ALLERGY AND CONGESTION 
    fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4320
    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
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIACETIN (UNII: XHX3C3X673)  
    ACETONE (UNII: 1364PS73AF)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    METHYLENE CHLORIDE (UNII: 588X2YUY0A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize19mm
    FlavorImprint Code 308;AV
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-4320-31 in 1 CARTON03/03/201103/01/2019
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-4320-52 in 1 CARTON03/03/2011
    25 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41167-4320-73 in 1 CARTON03/03/2011
    35 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02170403/03/2011
    Labeler - Chattem, Inc. (003336013)