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Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Labeler
Aurohealth LLC
Label updated
2026-08-25
Retrieved
2026-09-07
Active ingredients
CETIRIZINE HYDROCHLORIDE · PSEUDOEPHEDRINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Drug Facts

Active ingredients (in each extended release tablet)

Cetirizine HCl USP 5 mg
Pseudoephedrine HCl  USP 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
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
  • in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.
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 carton is opened or if individual blister units are torn or broken
Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose.

Questions or comments?
call 1-855-274-4122
(Monday - Friday 8:30 AM to 5:00 PM EST)

Distributed by: AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg/120 mg (12 x 2) Blister Carton

AUROHEALTH

NDC 58602-703-09

*Compare to the active
ingredients of Zyrtec-D®

Original Prescription Strength

Cetirizine Hydrochloride and
Pseudoephedrine Hydrochloride
Extended-Release Tablets, USP
5 mg/120 mg

Antihistamine/Nasal Decongestant

Indoor & Outdoor
Allergies

ALLERY + SINUS

NASAL CONGESTION + SINUS PRESSURE

12 Hour
relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Actual Size
24
EXTENDED-RELEASE TABLETS

[Image in the official label — see DailyMed source]

DailyMed Set ID: 26f2c3c1-a2f2-474a-950a-8cfe07f289fa · Version 4
NDC: 58602-703