CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE- cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, extended release 
Perrigo New York Inc

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Perrigo Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Drug Facts

Active ingredient (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.

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)

Inactive ingredients

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, yellow iron oxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Zyrtec-D® active ingredients

Original Prescription Strength

Cetirizine Hydrochloride and

Pseudoephedrine Hydrochloride

Extended Release Tablets, 5mg/120mg

Antihistamine/Nasal Decongestant

Allergy & Congestion

12 Hour Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat or Nose

Sinus Pressure

Nasal Congestion

Indoor & Outdoor Allergies

Actual Size

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Carton Image 1

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Carton Image 1

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Carton Image 2

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Carton Image 2

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
cetirizine hcl, pseudoephedrine hcl tablet, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:45802-721
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
TALC 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorWHITE (one side white one side light yellow) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code 5029;5;120
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45802-721-624 in 1 CARTON
16 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07717004/10/2008
Labeler - Perrigo New York Inc (078846912)

Revised: 3/2012
 
Perrigo New York Inc