Your browser does not support JavaScript! ZYRTEC-D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]
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RxNorm Names

ZYRTEC-D ALLERGY AND CONGESTION (cetirizine hydrochloride and pseudoephedrine hydrochloride) tablet, extended release
[McNeil Consumer Healthcare Div McNeil-PPC, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

Drug Facts

Active ingredients (in each extended release tablet)

Cetirizine HCl 5 mg

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 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 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)

Principal Display Panel
ZYRTEC-D  ALLERGY AND CONGESTION
cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-728
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine5 mg
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine120 mg
Product Characteristics
ColorWHITE (White to off white) Scoreno score
ShapeROUND (Biconvex) Size10mm
FlavorImprint Code Zyrtec;D
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-728-122 in 1 CARTON
16 in 1 BLISTER PACK
2NDC:50580-728-244 in 1 CARTON
26 in 1 BLISTER PACK
3NDC:50580-728-254 in 1 CARTON
36 in 1 BLISTER PACK
4NDC:50580-728-5012 in 1 CARTON
41 in 1 BLISTER PACK
5NDC:50580-728-5224 in 1 CARTON
51 in 1 BLISTER PACK
6NDC:50580-728-6824 in 1 CARTON
61 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02115001/01/2008
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 10/2009
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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