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ZYRTEC-D Allergy Plus Congestion

Medically reviewed on September 29, 2017

Dosage form: tablet, film coated, extended release
Ingredients: Cetirizine Hydrochloride 5mg, Pseudoephedrine Hydrochloride 120mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-728

ZYRTEC-D
Allergy Plus Congestion

Drug Facts

Active ingredients (in each extended release tablet)Purpose
Cetirizine HCl 5 mgAntihistamine
Pseudoephedrine HCl 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
    • nasal congestion
  • 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 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)

Directions
  • do not break or chew tablet; swallow tablet whole
adults and children 12 years and overtake 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and overask a doctor
children under 12 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information
  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened or if blister unit is broken

Inactive ingredients

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

Questions?

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

Original Prescription Strength
NDC 50580-728-24

ZYRTEC-D®

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

ALLERGY + CONGESTION

INDOOR + OUTDOOR
ALLERGIES

12
HOUR
RELIEF OF

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

(Actual Size)

24
EXTENDED
RELEASE TABLETS

ZYRTEC-D  ALLERGY PLUS CONGESTION
cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-728
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride5 mg
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride120 mg
Inactive Ingredients
Ingredient NameStrength
silicon dioxide 
croscarmellose sodium 
hypromellose, unspecified 
lactose monohydrate 
magnesium stearate 
microcrystalline cellulose 
polyethylene glycol, unspecified 
titanium dioxide 
Product Characteristics
ColorWHITE (White to off white) Scoreno score
ShapeROUND (Biconvex) Size10mm
FlavorImprint CodeZyrtec;D
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-728-122 BLISTER PACK in 1 CARTON
16 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:50580-728-244 BLISTER PACK in 1 CARTON
26 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
3NDC:50580-728-254 BLISTER PACK in 1 CARTON
36 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02115001/01/2008
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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