Cetirizine Hydrochloride CETIRIZINE AMNEAL 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 and throat
FunFoxMeds box
Route
ORAL
Applications
ANDA090765
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT (in each 5 mL teaspoonful) Cetirizine HCl 5 mg
Inactive Ingredients
INACTIVE INGREDIENTS Sucrose Glycerin Propylene Glycol Methylparaben Propylparaben Sodium Acetate Glacial Acetic Acid Artificial Grape Flavor Purified Water. Questions? Call 1-877-835-5472 Monday through Friday 9AM – 5PM EST. *This product is not manufactured or distributed by McNeil-PPC Inc. distributor of Zyrtec ® . Zyrtec ® is a registered trademark of UCB Pharma S.A. Distributed by: Amneal Pharmaceuticals Glasgow KY 42141 Rev. 03-2015-01
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 And Throat
Pill Appearance
Color: yellow

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0365162005868
UNII
64O047KTOA
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1 mg/mL Label 1 mg/mL Carton

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1 mg/mL Label 1 mg/mL 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 and 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 and 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 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (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) TAMPER EVIDENT: DO NOT USE IF NECKBAND IMPRINTED “SEALED FOR YOUR PROTECTION” IS BROKEN OR MISSSING.

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 breastfeeding: if breast-feeding: not recommended if pregnant: ask a health professional before use
Purpose

PURPOSE Antihistamine

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN Keep out of reach of children . In case of overdose, get medical help of contact a Poison Control Center right away. (1-800-222-1222)


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