Cetirizine Hydrochloride

Mylan Institutional Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purpose
• Cetirizine Hydrochloride Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding:
  • Keep out of reach of children.
• Directions (24 Hour Relief)
• Cetirizine Hydrochloride Other information
• Inactive ingredients
• Questions? 1-800-848-0462
• HOW SUPPLIED

FULL PRESCRIBING INFORMATION

CETIRIZINE HCl
10 mg TABLETS

Antihistamine

Indoor & Outdoor Allergies

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

Active ingredient (in each tablet)

Cetirizine Hydrochloride, USP 10 mg

Purpose

Antihistamine

Cetirizine Hydrochloride 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 (24 Hour Relief)

Cetirizine Hydrochloride Other information

• •store between 20° to 25°C (68° to 77°F)

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.
  

HOW SUPPLIED

Cetirizine Hydrochloride Tablets 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.

NDC 51079-597-20 - Unit dose blister packages
of 100 (10 cards of 10 tablets each).

Store between 20° to 25°C (68° to 77°F).

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-9827 R5
5/13

PRINCIPAL DISPLAY PANEL - 10 mg

NDC 51079-597-20

CETIRIZINE HCl
TABLETS
10 mg
Antihistamine
100 Tablets (10 x 10)

Indoor & Outdoor Allergies

24 Hour Relief (See Uses section of enclosed leaflet)
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 U.S.A

S-9828 R3

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.