ZYRTEC D ALLERGY AND CONGESTION - cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, extended release 
Physicians Total Care, Inc.

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ZYRTEC-D®

Drug Facts

Active ingredients (in each extended release tablet)

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

Nasal decongestant

Uses

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

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

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 54868-5879-0
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 DRUGItem Code (Source)NDC:54868-5879(NDC:50580-728)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine5 mg
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine120 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
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:54868-5879-024 in 1 CARTON
11 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02115003/28/2008
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 5/2012
Document Id: 8e580ba8-f7c1-4ba1-9b4b-d6c7a21d12d5
Set id: 3c9d819d-0f3f-4c76-9770-cf004b10299a
Version: 1
Effective Time: 20120523
 
Physicians Total Care, Inc.