ZYRTEC description, usages, side effects, indications, overdosage, supplying and lots more!

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ZYRTEC

Physicians Total Care, Inc.

ZYRTEC-D


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 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

ZYRTEC 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 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)

ZYRTEC

ZYRTEC

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54868-5879(NDC:50580-728)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 5 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 120 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to off white) 10 mm Zyrtec;D ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:54868-5879-0 24 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021150 2008-03-28


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Be sure to consult your doctor before taking any medication!
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