Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE OHM LABORATORIES 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 bottle
Route
ORAL
Applications
ANDA090142
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each chewable tablet) Cetirizine hydrochloride USP 10 mg
Inactive Ingredients
Inactive ingredients acesulfame potassium colloidal silicon dioxide compressible sugar crospovidone FD & C Blue No # 2 Aluminum Lake FD & C Red No # 40 Aluminum Lake guar gum magnesium oxide light powder magnesium stearate mannitol microcrystalline cellulose pregelatinized starch prosweet N & A flavor powder talc tutti frutti flavor
Strengths
10 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
Pill Appearance
Shape: round Color: purple Imprint: 344

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
64O047KTOA
Packaging

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton † Compare To the active ingredient of Children's Zyrtec ® NDC 51660-066-30 ohm ® Original Prescription Strength Cetirizine Hydrochloride Chewable Tablets 10 mg Antihistamine Allergy Tutti-frutti Flavor No Water Needed Indoor + Outdoor Allergies Actual Size 24 Hour Relief of: Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat or Nose 30 CHEWABLE TABLETS PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton † Compare To the active ingredient of Children's Zyrtec ® NDC 51660-066-30 ohm ® Original Prescription Strength Cetirizine Hydrochloride Chewable Tablets 10 mg Antihistamine Allergy Tutti-frutti Flavor No Water Needed Indoor + Outdoor Allergies Actual Size 24 Hour Relief of: Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat or Nose 30 CHEWABLE TABLETS PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle 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 may be taken with or without water chew or crush tablets completely before swallowing adults and children 6 years and over Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 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 inner safety seal is open or torn see side panel for lot number and expiration date

Questions

Questions? Call toll free 1-800-818-4555 weekdays


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