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

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each chewable tablet) For 5 mg: Cetirizine hydrochloride USP 5 mg For 10 mg: 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
5 mg 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 UNKNOWN
UPC
0347335344837 0347335343830
UNII
64O047KTOA
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL For 5 mg Allergy: Original Prescription Strength NDC 47335-343-83 Cetirizine Hydrochloride Chewable Tablets 5 mg ALLERGY Antihistamine Indoor + Outdoor Allergies Actual Size Tutti-frutti Flavor 6 yrs & older 30 CHEWABLE TABLETS SUN PHARMACEUTICAL INDUSTRIES LTD. spl-cetirizine-5mg-allergy-1 spl-cetirizine-5mg-allergy-2 spl-cetirizine-5mg-allergy-3 spl-cetirizine-5mg-allergy-4 spl-cetirizine-5mg-allergy-5 spl-cetirizine-5mg-allergy-6 spl-cetirizine-5mg-allergy-7; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL For 10 mg Allergy: Original Prescription Strength NDC 47335-344-83 Cetirizine Hydrochloride Chewable Tablets 10 mg ALLERGY Antihistamine Indoor + Outdoor Allergies Actual Size Tutti-frutti Flavor 6 yrs & older 30 CHEWABLE TABLETS SUN PHARMA spl-cetirizine-10mg-allergy-1 spl-cetirizine-10mg-allergy-22 spl-cetirizine-10mg-allergy-33

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL For 5 mg Allergy: Original Prescription Strength NDC 47335-343-83 Cetirizine Hydrochloride Chewable Tablets 5 mg ALLERGY Antihistamine Indoor + Outdoor Allergies Actual Size Tutti-frutti Flavor 6 yrs & older 30 CHEWABLE TABLETS SUN PHARMACEUTICAL INDUSTRIES LTD. spl-cetirizine-5mg-allergy-1 spl-cetirizine-5mg-allergy-2 spl-cetirizine-5mg-allergy-3 spl-cetirizine-5mg-allergy-4 spl-cetirizine-5mg-allergy-5 spl-cetirizine-5mg-allergy-6 spl-cetirizine-5mg-allergy-7
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL For 10 mg Allergy: Original Prescription Strength NDC 47335-344-83 Cetirizine Hydrochloride Chewable Tablets 10 mg ALLERGY Antihistamine Indoor + Outdoor Allergies Actual Size Tutti-frutti Flavor 6 yrs & older 30 CHEWABLE TABLETS SUN PHARMA spl-cetirizine-10mg-allergy-1 spl-cetirizine-10mg-allergy-22 spl-cetirizine-10mg-allergy-33

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 For 5 mg: adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours. adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For 10 mg: 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
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 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 top layer for lot number and expiration date


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