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  5. Label Information: Cetirizine Hydrochloride

FDA Label for Cetirizine 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. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING:
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 MG (24 ORALLY DISINTEGRATING TABLETS) BLISTER CARTON

Cetirizine 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 ingredient (in each tablet)

Cetirizine hydrochloride USP 10 mg


Purpose



Antihistamine


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

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.


Ask A Doctor Before Use If You Have



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



  • 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.


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



Tablet melts in mouth. Can be taken with or without water.

adults and children 6 years and over
one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 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). Avoid high humidity.
  • do not use if carton or blister unit is opened or broken 
  • see side panel for lot number and expiration date

Inactive Ingredients



betadex, citric acid anhydrous, colloidal silicon dioxide, crospovidone, dl-alpha-tocopherol, hydroxypropyl cellulose, magnesium stearate, maize maltodextrin, mannitol, microcrystalline cellulose, natural flavourings, sodium bicarbonate, sodium starch glycolate and sucralose.

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 -10 Mg (24 Orally Disintegrating Tablets) Blister Carton



Healthy Living™
NDC 58602-860-76
*Compare to the active
ingredient of Zyrtec® Allergy
Original Prescription Strength
Cetirizine Hydrochloride
Orally Disintegrating Tablets, USP 10 mg
Antihistamine
Allergy
Dissolve Tabs
Melts In Your Mouth
ORANGE FLAVOR
Indoor + Outdoor Allergies 
24 Hour Relief of:

* Please review the disclaimer below.