Cetirizine Hydrochloride

Cetirizine Hydrochloride cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE ANHYDROUS LACTOSE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM LAURYL SULFATE TITANIUM DIOXIDE TRIACETIN M;C37

CETIRIZINE HCl 10 mg TABLETS, USP Antihistamine Indoor & Outdoor Allergies TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. Other information • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] HOW SUPPLIED Cetirizine Hydrochloride Tablets, USP are available as follows: 10 mg - White, film-coated, round, biconvex, beveled edge, unscored tablets debossed with M on one side of the tablet and C37 on the other side. Overbagged with 10 film-coated tablets per bag, NDC 55154-5399-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India Code No.: MH/DRUGS/25/NKD/89 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. Distributed By: Cardinal Health Dublin, OH 43017 L48853561223 S-12769 10/21

Active ingredient (in each tablet) Cetirizine Hydrochloride, USP 10 mg

Purpose Antihistamine

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

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.

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.

Directions (24 Hour Relief) 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

<table width="100%"><col width="22%"/><col width="78%"/><tbody><tr><td styleCode="Rrule Botrule Toprule " valign="top"><paragraph>adults and children 6 years and over </paragraph></td><td styleCode="Botrule Toprule " valign="top"><paragraph>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.</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph>adults 65 years and over </paragraph></td><td styleCode="Botrule " valign="top"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph>children under 6 years of age </paragraph></td><td styleCode="Botrule " valign="top"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph>consumers with liver or kidney disease </paragraph></td><td styleCode="Botrule " valign="top"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>

Inactive ingredients Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

Questions? 1-800-848-0462 • Serious side effects associated with use of this product may be reported to this number.

Principal Display Panel NDC 55154-5399-0 CETIRIZINE HCl TABLETS, USP 10 mg 10 TABLETS 10mg bag label