Zyrtec-D 12 Hour

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

More Zyrtec-D 12 Hour resources

• Zyrtec-D 12 Hour Side Effects (in more detail)
• Zyrtec-D 12 Hour Dosage
• Zyrtec-D 12 Hour Use in Pregnancy & Breastfeeding
• Zyrtec-D 12 Hour Drug Interactions
• Zyrtec-D 12 Hour Support Group
• 1 Review for Zyrtec-D2 Hour - Add your own review/rating

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