CETIRIZINE HYDROCHLORIDE  - cetirizine tablet 
REMEDYREPACK INC.

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OTC - ACTIVE INGREDIENT

(in each tablet)
Cetirizine HCl 5 mg

OTC - PURPOSE

Antihistamine

USES

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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     runny nose

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     sneezing

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     itchy, watery eyes

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     itching of the nose or throat

WARNINGS

Do not use if you have ever had an allergic reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

OTC - ASK DOCTOR

liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - ASK DOCTOR/PHARMACIST

before use if you are taking tranquilizers or sedatives.

OTC - WHEN USING

drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

OTC - STOP USE

if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING

if breast-feeding: not recommended if pregnant: ask a health professional before use.

OTC - 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	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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide.

HOW SUPPLIED

Cetirizine Hydrochloride Tablets, USP 5 mg  are supplied as white to off-white,square tablets, debossed “APO 5mg” on obverse and plain on the reverse.

They are available as follows:

Bottles of 100:   NDC 60505-2632-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: CETIRIZINE HYDROCHLORIDE
GENERIC: CETIRIZINE HYDROCHLORIDE
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 49349-088-02
STRENGTH:5 mg
COLOR: white
SHAPE: SQUARE
SCORE: No score
SIZE: 6 mm
IMPRINT: APO;5
QTY: 30

CETIRIZINE HYDROCHLORIDE  cetirizine hydrochloride   tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49349-088 (60505-2632-1) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE (CETIRIZINE) CETIRIZINE 5 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN   HYPROMELLOSES   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   POVIDONE   TITANIUM DIOXIDE   POLYETHYLENE GLYCOL

Product Characteristics Color white Score no score Shape SQUARE (TABLET) Size 6mm Flavor Imprint Code APO;5 Contains

Packaging # NDC Package Description Multilevel Packaging 1 49349-088-02 30 TABLET In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075659	11/23/2010

Labeler - REMEDYREPACK INC. (829572556)

Revised: 11/2010REMEDYREPACK INC.