OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT(in each tablet)Cetirizine HCl 10 mg

OTC - 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 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

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

HOW SUPPLIEDCetirizine Hydrochloride Tablets, USP 10 mg are supplied as white to off-white,square tablets, debossed APO 10mg on obverse andplain on the reverse. page 2 of 3 They are available as follows:Bottles of 100: NDC 60505-2633-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: CETIRIZINE HYDROCHLORIDE
GENERIC: CETIRIZINE HYDROCHLORIDE
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 49349-105-02
STRENGTH:10 mg
COLOR: white
SHAPE: SQUARE
SCORE: No score
SIZE: 6 mm
IMPRINT: APO;10;MG
QTY: 30

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	49349-105 (60505-2633-1)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE (CETIRIZINE)	CETIRIZINE	10 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;10;MG
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	49349-105-02	30 TABLET In 1 BLISTER PACK	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075659	12/01/2010

Labeler - REMEDYREPACK INC. (829572556)

Revised: 12/2010REMEDYREPACK INC.