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See all Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride brands

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Dosage form: tablet, extended release
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg, PSEUDOEPHEDRINE HYDROCHLORIDE 120mg
Labeler: Perrigo New York Inc
NDC code: 45802-721

Medically reviewed by Drugs.com. Last updated on Nov 22, 2023.

Perrigo Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 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.

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

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Compare to Zyrtec-D® active ingredients

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Extended Release Tablets

5 mg/120 mg

Antihistamine / Nasal Decongestant

12 Hour Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat or Nose

Sinus Pressure

Nasal Congestion

actual size

Original Prescription Strength

Indoor & Outdoor Allergies

12 Extended Release Tablets

Allergy & Congestion

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
cetirizine hcl, pseudoephedrine hcl tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem 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, UNSPECIFIED 
HYPROMELLOSE, UNSPECIFIED 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
TALC 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorWHITE (one side white one side light yellow) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code5029;5;120
Contains    
Packaging
#Item CodePackage Description
1NDC:45802-721-6224 BLISTER PACK in 1 CARTON
11 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:45802-721-5312 BLISTER PACK in 1 CARTON
21 TABLET, EXTENDED RELEASE 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)

 
Perrigo New York Inc

See all Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.