Childrens Cetirizine Hydrochloride Hives Relief Solution
FDA Label NDC 58602-036

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 Hives Relief (NDC 58602-036). 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, warnings, 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, 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

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.


Warnings


Severe Allergy Warning:

Get emergency help immediately if you have hives along with any of the following symptoms: 


  • trouble swallowing
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • drooling
  • wheezing or problems breathing

    • These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

    Not a Substitute for Epinephrine    . If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do Not Use

  • to prevent hives from any known cause such as: 
    • foods                   
    • insect stings
    • medicines                
    • latex or rubber gloves

      • because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. 


      • 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.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks

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 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)
  • Do not use if carton is opened, or if cap safety seal is broken or missing.

Inactive Ingredients


banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

Questions?


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

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


AUROHEALTH

NDC 58602-036-15

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

HIVES RELIEF

24
Hour relief      Reduces Itching          Reduces
                         Due to Hives               Hives
6 yrs &
older

4 fl oz (120 mL)

Grape Flavor


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 58602-036-15

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

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

Hives
Relief
6 yrs &
older

HIVES RELIEF



24 Hour relief
Reduces Itching          Reduces
Due to Hives                Hives

Grape 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.