CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, film coated
Major Pharmaceuticals

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Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl 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° and 25°C (68° - 77°F)

Inactive ingredients

Lactose Monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol, and titanium dioxide.

Questions or comments?

To Report an Adverse Event call 1-800-616-2417

Distributed By

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150, USA

PRINCIPAL DISPLAY PANEL - 10 mg

MAJOR PHARMACEUTICALS. NDC0904-5852

Cetirizine 10 mg

Cetirizine Hydrochloride Tablets

Antihistamine/Original Prescription Strength

Indoor & Outdoor Allergies

24 hour

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Keep the Carton. It contains important information. See end panel for expiration date.

*This product is not manufactured or distrubuted by McNeil-PPC, Inc., distributor of Zyrtec®. Zyrtec® is a registered trademark of UCB Pharma, S.A. All Day Allergy Carton

All Day Allergy Carton

All Day Allergy 100 Ct Bottle Label

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-5852(NDC:60505-2633)
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
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
MAGNESIUM STEARATE
HYPROMELLOSES
POLYDEXTROSE
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE	Score	no score
Shape	RECTANGLE (pillow-shaped)	Size	9mm
Flavor		Imprint Code	10MG;APO
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0904-5852-41	14 TABLET, FILM COATED (14 TABLET) in 1 BOTTLE	None
2	NDC:0904-5852-43	45 TABLET, FILM COATED (45 TABLET) in 1 BOTTLE	None
3	NDC:0904-5852-46	30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE	None
4	NDC:0904-5852-60	100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE	None
5	NDC:0904-5852-89	90 TABLET, FILM COATED (90 TABLET) in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078317	12/27/2007

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Operations
Legacy Pharmaceutical Packaging		143213275	RELABEL, REPACK

Revised: 02/2012 Major Pharmaceuticals