Childrens Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE SUN PHARMACEUTICAL INDUSTRIES, INC. 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 box
Route
ORAL
Applications
ANDA090182

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL) Cetirizine HCl 5 mg
Inactive Ingredients
Inactive ingredients artificial grape flavor glacial acetic acid glycerin propylene glycol purified water sodium acetate anhydrous sodium benzoate sucralose
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

Identifiers & Packaging

Container Type BOX
UPC
0351672214784
UNII
64O047KTOA
Packaging

120 mL Carton Compare to the active ingredient in Children's Zyrtec ® * NDC 51672-2147-8 Carton

Package Descriptions
  • 120 mL Carton Compare to the active ingredient in Children's Zyrtec ® * NDC 51672-2147-8 Carton

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 older 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 each 5mL contains: sodium 4 mg do not use if carton is opened or if imprinted safety seal is broken or missing see bottom panel for lot number and expiration date store between 20° to 25°C (68° to 77°F)

Questions

Questions? Call 1-866-923-4914


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