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FDA > Zyrtec-D 12 Hour

Zyrtec-D 12 Hour

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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

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 NDC Product Code (Source) 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
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Biconvex) Size 10mm
Flavor Imprint Code Zyrtec;D
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 50580-728-12 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK
1 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (50580-728-12)
2 50580-728-24 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK
2 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (50580-728-24)
3 50580-728-25 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK
3 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (50580-728-25)
4 50580-728-50 12 BLISTER PACK In 1 CARTON contains a BLISTER PACK
4 1 TABLET In 1 BLISTER PACK This package is contained within the CARTON (50580-728-50)
5 50580-728-52 24 BLISTER PACK In 1 CARTON contains a BLISTER PACK
5 1 TABLET In 1 BLISTER PACK This package is contained within the CARTON (50580-728-52)
6 50580-728-68 24 BLISTER PACK In 1 CARTON contains a BLISTER PACK
6 1 TABLET In 1 BLISTER PACK This package is contained within the CARTON (50580-728-68)

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



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