Childrens Cetirizine Hydrochloride Allergy CETIRIZINE HYDROCHLORIDE AUROHEALTH LLC FDA Approved 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
FunFoxMeds bottle
Route
ORAL
Applications
ANDA090750

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL) Cetirizine hydrochloride USP 5 mg
Inactive Ingredients
Inactive ingredients cherry mint flavor glacial acetic acid glycerin methylparaben propylene glycol propylparaben purified water sodium acetate trihydrate sucrose
Strengths
5 ml 5 mg
Quantities
120 ml
Treats Conditions
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
Pill Appearance
Color: yellow

Identifiers & Packaging

Container Type BOTTLE
UPC
0358602028244
UNII
64O047KTOA
Packaging

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 24 Hour relief of Sneezing Runny Nose Itchy, Watery Itchy Throat Dye-Free Eyes or Nose Alcohol-Free ALLERGY Indoor & Outdoor Allergies 2 yrs & older 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 Carton (120 mL) AUROHEALTH NDC 58602-028-24 *Compare to 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 Itchy Throat Dye-Free Eyes or Nose Alcohol-Free Cherry Flavor 4 fl oz (120 mL) Dosing cup included PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)

Package Descriptions
  • 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 24 Hour relief of Sneezing Runny Nose Itchy, Watery Itchy Throat Dye-Free Eyes or Nose Alcohol-Free ALLERGY Indoor & Outdoor Allergies 2 yrs & older 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 Carton (120 mL) AUROHEALTH NDC 58602-028-24 *Compare to 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 Itchy Throat Dye-Free Eyes or Nose Alcohol-Free Cherry Flavor 4 fl oz (120 mL) Dosing cup included PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
Warnings 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)
Purpose

Purpose Antihistamine

Do Not Use

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.

When Using

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 & Ask a Doctor

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Keep Out of Reach of Children

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)

Storage & Handling

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

Questions

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


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