Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE MYLAN PHARMACEUTICALS 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 tablet) Cetirizine hydrochloride USP 5 mg
Inactive Ingredients
Inactive ingredients Anhydrous lactose colloidal silicon dioxide hypromellose magnesium stearate microcrystalline cellulose polydextrose polyethylene glycol sodium lauryl sulfate titanium dioxide and triacetin
Strengths
5 mg
Quantities
100 tablets
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: white Imprint: M;C37

Identifiers & Packaging

Container Type BOTTLE
UNII
64O047KTOA
Packaging

PRINCIPAL DISPLAY PANEL - 5 mg Allergy NDC 0378-3635-01 Cetirizine HCl Tablets, USP Allergy 5 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat RMX-AR3635A 100 Tablets Tamper Evident: do not use if foil seal under cap is missing, open or broken. Cetirizine Hydrochloride Tablets 5 mg - Front Layer - Bottle Label Cetirizine Hydrochloride Tablets 5 mg - Back of Front Layer - Bottle Label Cetirizine Hydrochloride Tablets 5 mg - Base Layer - Bottle Label; PRINCIPAL DISPLAY PANEL - 10 mg Allergy NDC 0378-3637-01 Cetirizine HCl Tablets, USP Allergy 10 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat RMX-AR3637A 100 Tablets Tamper Evident: do not use if foil seal under cap is missing, open or broken. Active Ingredient (in each tablet) Cetirizine hydrochloride USP, 10 mg Directions adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet 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 Cetirizine Hydrochloride Tablets 10 mg - Front Layer - Bottle Label Cetirizine Hydrochloride Tablets 10 mg - Back of Front Layer - Bottle Label Cetirizine Hydrochloride Tablets 10 mg - Base Layer - Bottle Label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 5 mg Allergy NDC 0378-3635-01 Cetirizine HCl Tablets, USP Allergy 5 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat RMX-AR3635A 100 Tablets Tamper Evident: do not use if foil seal under cap is missing, open or broken. Cetirizine Hydrochloride Tablets 5 mg - Front Layer - Bottle Label Cetirizine Hydrochloride Tablets 5 mg - Back of Front Layer - Bottle Label Cetirizine Hydrochloride Tablets 5 mg - Base Layer - Bottle Label
  • PRINCIPAL DISPLAY PANEL - 10 mg Allergy NDC 0378-3637-01 Cetirizine HCl Tablets, USP Allergy 10 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat RMX-AR3637A 100 Tablets Tamper Evident: do not use if foil seal under cap is missing, open or broken. Active Ingredient (in each tablet) Cetirizine hydrochloride USP, 10 mg Directions adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet 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 Cetirizine Hydrochloride Tablets 10 mg - Front Layer - Bottle Label Cetirizine Hydrochloride Tablets 10 mg - Back of Front Layer - Bottle Label Cetirizine Hydrochloride Tablets 10 mg - Base Layer - Bottle 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 adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours 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.
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.

Questions

Questions? Call 1-877-446-3679 (1-877-4-INFO-RX) Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505


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