Childrens Cetirizine Hydrochloride Allergy Solution
FDA Label NDC 58602-028

16 label sections · Submitted to the FDA by Aurohealth Llc · 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 Allergy (NDC 58602-028). 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 active ingredient (in each 5 ml), 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

Active Ingredient (In Each 5 Ml)


Cetirizine hydrochloride USP 5 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
  •  in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.

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


  • use only with enclosed dosing cup
  • find right dose on chart below
  • mL = milliliter

    • adults and children 6 years and over
    		 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
    adults 65 years and over
    		 5 mL once daily; do not take more than 5 mL in 24 hours.
    children 2 to under 6 years of age
    		 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
    children under 2 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 cap safety seal is broken or missing.
  • see bottom panel for lot number and expiration date

Inactive Ingredients


cherry mint flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate trihydrate, sucrose

Questions?


call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Package Label-Principal Display Panel - 1 Mg/Ml (120 Ml Bottle)


AUROHEALTH

NDC 58602-028-24

Children’s
Cetirizine Hydrochloride
Oral Solution USP 1 mg/mL
antihistamine
ALLERGY

Indoor &
Outdoor
Allergies
2 yrs &
older

24 Hour
relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
Dye-Free Alcohol-Free

Cherry Flavor
4 fl oz (120 mL)

Package Label-principal Display Panel (1 mg/mL (120 mL Bottle))

Package Label-principal Display Panel (1 mg/mL (120 mL Bottle))


Package Label-Principal Display Panel - 1 Mg/Ml Carton (120 Ml)



AUROHEALTH

NDC 58602-028-24

*Compare to the active ingredient
in Children’s ZYRTEC®

Children’s
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine

ALLERGY

Indoor &
Outdoor
Allergies


 2 yrs &
older



24 Hour
relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
Dye-Free Alcohol-Free



 Cherry Flavor
 4 fl oz (120 mL)


Dosing cup
included


Package Label-principal Display Panel (1 mg/mL Carton (120 mL))

Package Label-principal Display Panel (1 mg/mL Carton (120 mL))


* Please review the disclaimer below.