Drug Facts
Active ingredient (in each tablet)
Cetirizine hydrochloride USP 10 mg
Childrens Cetirizine Hydrochloride Tablet, Orally Disintegrating
FDA Label NDC 58602-856
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 Childrens Cetirizine Hydrochloride (NDC 58602-856). 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
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
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
2572 Brunswick Pike
Lawrenceville, NJ 08648
Made in India
Code: AP/DRUGS/04/2016
Package Label-Principal Display Panel -10 Mg (12 Orally Disintegrating Tablets) Blister Carton
AUROHEALTH
NDC 58602-856-75
*Compare to the active
ingredient of Children's Zyrtec® Allergy
Original Prescription Strength
Children's
Cetirizine Hydrochloride
Orally Disintegrating Tablets, USP 10 mg
Antihistamine
Allergy
Dissolve Tabs
6 yrs. & older
Indoor + Outdoor Allergies
24 Hour Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Melts In Your Mouth
ORANGE FLAVOR
Actual Size
12 Package Label-principal Display Panel -10 mg (12 Orally Disintegrating Tablets) Blister Carton (Cetirizine Fig1)
Orally
Disintegrating
Tablets
10 mg each 
* Please review the disclaimer below.
