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

do not use if blister unit is broken or torn (Blister Only)
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

corn starch, FD&C blue no. 1, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Zyrtec® active ingredient

Indoor & Outdoor Allergies

Original Prescription Strength

All Day Allergy

Cetirizine Hydrochloride Tablets, 10 mg

Antihistamine

24 Hour Relief of:

Sneezing

Runny Nose

Itchy Throat or Nose

Itchy, Watery Eyes

Actual Size

All Day Allergy Tablets Carton

LEADER ALL DAY ALLERGY
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	37205-825
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
No Inactive Ingredients Found

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	4H2
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	37205-825-74	1 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
1		14 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (37205-825-74)
2	37205-825-65	1 BOTTLE In 1 PACKAGE	contains a BOTTLE
2		30 TABLET In 1 BOTTLE	This package is contained within the PACKAGE (37205-825-65)
3	37205-825-75	1 BOTTLE In 1 PACKAGE	contains a BOTTLE
3		90 TABLET In 1 BOTTLE	This package is contained within the PACKAGE (37205-825-75)
4	37205-825-70	1 BOTTLE In 1 PACKAGE	contains a BOTTLE
4		45 TABLET In 1 BOTTLE	This package is contained within the PACKAGE (37205-825-70)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078336	01/16/2008

Labeler - Cardinal Health (097537435)

Revised: 05/2009Cardinal Health