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Zyrtec-D 12 Hour

Generic Name: cetirizine hydrochloride and pseudoephedrine hydrochloride
Dosage Form: tablet, extended release

ZYRTEC-D®

Drug Facts

Active ingredients (in each extended release tablet)

Cetirizine HCl 5 mg

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

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
    • 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 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

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

Inactive ingredients

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

Questions?

call 1-800-343-7805

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)

ZYRTEC-D  ALLERGY AND CONGESTION
cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product Type HUMAN OTC DRUG 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
1 NDC:50580-728-12 2 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 6 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
2 NDC:50580-728-24 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 6 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
3 NDC:50580-728-25 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
3 6 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
4 NDC:50580-728-50 12 BLISTER PACK (BLISTER PACK) in 1 CARTON
4 1 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
5 NDC:50580-728-52 24 BLISTER PACK (BLISTER PACK) in 1 CARTON
5 1 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
6 NDC:50580-728-68 24 BLISTER PACK (BLISTER PACK) in 1 CARTON
6 1 TABLET, EXTENDED RELEASE (TABLET) 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)
Revised: 10/2009
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc



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