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Cetirizine hydrochloride and Pseudoephedrine hydrochloride

Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Labeler
Padagis Israel Pharmaceuticals Ltd
Label updated
2025-02-12
Retrieved
2026-09-07
Active ingredients
CETIRIZINE HYDROCHLORIDE · PSEUDOEPHEDRINE HYDROCHLORIDE
View original label and images on DailyMed ↗
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 overtake 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.adults 65 years and overask a doctorchildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor
 
 
 
 
 
 
 
 
Other information
  • •store between 20° to 25°C (68° to 77°F)
  • do not use if blister unit is broken or torn
  • •see side panel for lot number and expiration date
  • •meets USP Dissolution Test 2
Inactive ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Zyrtec-D® active ingredients

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Extended Release Tablets

5 mg/120 mg

Antihistamine / Nasal Decongestant

NASAL CONGESTION + SINUS PRESSURE

• Sneezing

• Itchy, Watery Eyes

• Runny Nose

• Itchy Nose or Throat

Indoor + Outdoor Allergies

12 HOUR RELIEF

Allergy + Sinus

Original Prescription Strength

actual size

24 Extended Release Tablets

Padagis®

[Image in the official label — see DailyMed source]

DailyMed Set ID: 3260111b-35da-4f95-8081-51eae4b1ef45 · Version 5
NDC: 45802-147