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  5. Label Information: Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride

FDA Label for Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING:
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 MG/120 MG (12 X 2) BLISTER CARTON

Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Aurohealth Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

* Please review the disclaimer below.