Label: ZYRTEC-D ALLERGY AND CONGESTION - cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, extended release 

  • Label RSS
  • NDC Code(s): 50580-728-12, 50580-728-24, 50580-728-25, 50580-728-50, view more
    50580-728-52, 50580-728-68
  • Packager: McNeil Consumer Healthcare Div McNeil-PPC, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/09

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredients (in each extended release tablet)

    Cetirizine HCl 5 mg

    Pseudoephedrine HCl 120 mg

    Close
  • Purpose

    Antihistamine

    Nasal decongestant

    Close
  • 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
      • nasal congestion
    • reduces swelling of nasal passages
    • temporarily relieves sinus congestion and pressure
    • temporarily restores freer breathing through the nose
    Close
  • Warnings

    Do not use

    • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
    • 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.

    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • diabetes
    • glaucoma
    • high blood pressure
    • trouble urinating due to an enlarged prostate gland
    • liver or kidney disease. Your doctor should determine if you need a different dose.

    Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

    When using this product

    • do not use more than directed
    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • an allergic reaction to this product occurs. Seek medical help right away.
    • you get nervous, dizzy, or sleepless
    • symptoms do not improve within 7 days or are accompanied by fever

    If pregnant or breast-feeding:

    • if breast-feeding: not recommended
    • if pregnant: 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. (1-800-222-1222)

    Close
  • Directions

    • do not break or chew tablet; swallow tablet whole
    adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
    adults 65 years and over ask a doctor
    children under 12 years of age ask a doctor
    consumers with liver or kidney disease ask a doctor
    Close
  • Other information

    • store between 20° to 25°C (68° to 77°F)
    • do not use if individual blister unit is open or torn
    • see back panel for lot number and expiration date
    Close
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

    Close
  • Questions?

    call 1-800-343-7805

    Close
  • PRINCIPAL DISPLAY PANEL

    NDC 50580-728-52
    Original Prescription Strength

    ZYRTEC-D®

    Cetirizine HCl 5 mg/antihistamine
    Pseudoephedrine HCl 120 mg/nasal decongestant
    Extended Release Tablets

    Indoor & Outdoor Allergies

    ALLERGY & CONGESTION

    12
    hour

    Relief of
    • Sneezing
    • Runny Nose
    • Sinus Pressure
     
    • Itchy, Watery Eyes
    • Itchy Throat or Nose
    • Nasal Congestion

    24
    Extended
    Release
    Tablets

    (individual Blisters)

    Principal Display Panel
    Close
  • INGREDIENTS AND APPEARANCE
    ZYRTEC-D  ALLERGY AND CONGESTION
    cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50580-728
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Cetirizine Hydrochloride (Cetirizine) Cetirizine 5 mg
    Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine 120 mg
    Product Characteristics
    Color WHITE (White to off white) Score no score
    Shape ROUND (Biconvex) Size 10mm
    Flavor Imprint Code Zyrtec;D
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-728-12 2 in 1 CARTON
    1 6 in 1 BLISTER PACK
    2 NDC:50580-728-24 4 in 1 CARTON
    2 6 in 1 BLISTER PACK
    3 NDC:50580-728-25 4 in 1 CARTON
    3 6 in 1 BLISTER PACK
    4 NDC:50580-728-50 12 in 1 CARTON
    4 1 in 1 BLISTER PACK
    5 NDC:50580-728-52 24 in 1 CARTON
    5 1 in 1 BLISTER PACK
    6 NDC:50580-728-68 24 in 1 CARTON
    6 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021150 01/01/2008
    Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)
    Close