pilldic.Your medicine dictionary
Text size
← US medicines
US · Over-the-counter medicine

Cetirizine HCl and Pseudoephedrine HClER

Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Labeler
Physicians Total Care, Inc.
Label updated
2010-06-07
Retrieved
2026-09-07
Active ingredients
CETIRIZINE HYDROCHLORIDE · PSEUDOEPHEDRINE HYDROCHLORIDE
View original label and images on DailyMed ↗
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
    • itchy, watery eyes
    • nasal congestion
    • sneezing
    • itching of the nose or throat
  • 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
  • Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
  • DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN (for blister package only).

보관·기타 정보

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, D & C yellow aluminum lake, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, and titanium dioxide.

Questions or comments?

1-800-525-8747

Label information

Sandoz Inc.

Princeton, NJ 08540

05-2010M



Relabeling of Additional Barcode by:
Physicians Total Care, Inc.
Tulsa, OK     74146

Label information

HOW SUPPLIED:


30 Tablets, Bottles              NDC 54868-5884-1

60 Tablets, Bottles              NDC 54868-5884-0

24 Tablets, Blister Pack      NDC 54868-5884-2

5 mg/120 mg Label

Cetirizine HCl and

Pseudoephedrine HCl

Extended Release Tablets

5 mg/120 mg

antihistamine/

nasal decongestant

Indoor & Outdoor Allergies

ALLERGY & CONGESTION

12 hour Relief of

Runny Nose Itchy, Watery Eyes Sinus Pressure

Sneezing Itchy Throat or Nose Nasal Congestion

[Image in the official label — see DailyMed source]

DailyMed Set ID: c8b28b1a-d7de-42d0-96bf-a1e04253892f · Version 2
NDC: 54868-5884