CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, film coated 
UDL Laboratories Ltd.

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Drug Facts

Active ingredient (in each tablet)

Cetirizine Hydrochloride 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.

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

Other information

• store between 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL - 10 mg

NDC 51079-597-20

CETIRIZINE
HYDROCHLORIDE
TABLETS
10 mg
antihistamine
100 Tablets (10 x 10)

Indoor & Outdoor Allergies

TAMPER EVIDENT: DO NOT USE IF BLISTER
UNITS ARE TORN, BROKEN OR SHOW ANY
SIGNS OF TAMPERING.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

S-9828 R1

Packaged and Distributed by:
UDL LABORATORIES, INC.
ROCKFORD, IL 61103

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

CETIRIZINE HYDROCHLORIDE  cetirizine hydrochloride   tablet, film coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 51079-597 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   SILICON DIOXIDE   HYPROMELLOSES   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYDEXTROSE   POLYETHYLENE GLYCOL   SODIUM LAURYL SULFATE   TITANIUM DIOXIDE   TRIACETIN

Product Characteristics Color WHITE Score no score Shape ROUND Size 8mm Flavor Imprint Code M;C37 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51079-597-20 100 BLISTER PACK In 1 BOX, UNIT-DOSE contains a BLISTER PACK (51079-597-01) 1 51079-597-01 1 TABLET In 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51079-597-20)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076677	02/09/2011

Labeler - UDL Laboratories Ltd. (039615992)

Revised: 11/2009UDL Laboratories Ltd.