Cetirizine Hydrochloride Tablet, Orally Disintegrating
FDA Label NDC 69842-234

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Cetirizine Hydrochloride (NDC 69842-234). 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, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2021 CVS/pharmacy
CVS.com® 1-800-SHOP CVS  

Made in India

Code: AP/DRUGS/04/2016


Package Label-Principal Display Panel -10 Mg (24 Orally Disintegrating Tablets) Blister Carton

CVSHealth®
Compare to the active
ingredient of Zyrtec® Allergy*
Indoor & Outdoor Allergies
NDC 69842-234-76
Original Prescription Strength
Allergy
CETIRIZINE HYDROCHLORIDE
ORALLY DISINTEGRATING TABLETS,
USP 10 mg
Antihistamine
Dissolve Tabs
24 HOUR
24 HOUR Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

    • 24 Orally Disintegrating Tablets
    10 mg each
    Melts In Your Mouth
    ORANGE FLAVOR
    Actual Size

    Package Label-principal Display Panel -10 mg (12 Orally Disintegrating Tablets) Blister Carton (Cetirizine Fig1)

    Package Label-principal Display Panel -10 mg (12 Orally Disintegrating Tablets) Blister Carton (Cetirizine Fig1)

* Please review the disclaimer below.