Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride Tablet, Film Coated, Extended Release
FDA Label NDC 58602-703

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride (NDC 58602-703). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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

Code: AP/DRUGS/04/2016


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
Allergy & Sinus
INDOOR & OUTDOOR
ALLERGIES
12 HOUR RELIEF

NASAL CONGESTION & SINUS  PRESSURE

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy  Nose or Throat

    • (Actual Size) 

    24 EXTENDED-RELEASE TABLETS

    Package Label-principal Display Panel -5 mg/120 mg (12 X 2) Blister Carton (Cetirizine Pseudo Fig1)

    Package Label-principal Display Panel -5 mg/120 mg (12 X 2) Blister Carton (Cetirizine Pseudo Fig1)

* Please review the disclaimer below.