CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE QUAGEN PHARMACEUTICALS 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
ANDA212266

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL) Cetirizine HCl 5 mg
Inactive Ingredients
Inactive ingredients Bubble Gum Syrup: anhydrous citric acid artificial bubble gum flavor propylene glycol purified water sodium benzoate sorbitol solution sucralose Grape Syrup: anhydrous citric acid artificial grape flavor propylene glycol purified water sodium benzoate sorbitol solution sucralose
Strengths
5 ml 5 mg
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 BOTTLE
UPC
0370752104067
UNII
64O047KTOA
Packaging

PRINCIPAL DISPLAY PANEL - Grape Flavor - Container Label Cetirizine Hydrochloride Oral Solution, 1 mgmL - Grape Flavor - Label; PRINCIPAL DISPLAY PANEL - Grape Flavor-Carton Label Cetirizine Hydrochloride Oral Solution, 1 mgmL - Grape Flavor - Container Label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - Grape Flavor - Container Label Cetirizine Hydrochloride Oral Solution, 1 mgmL - Grape Flavor - Label
  • PRINCIPAL DISPLAY PANEL - Grape Flavor-Carton Label Cetirizine Hydrochloride Oral Solution, 1 mgmL - Grape Flavor - Container Label

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. Side effects occur: You may report side effects to FDA at 1-800-FDA-1088. 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. Side effects occur: You may report side effects to FDA at 1-800-FDA-1088.

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) Protect from light do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing see bottom panel for lot number and expiration date

Questions

Questions? Call 1-888-344-9603 (toll-free)


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