WAL ZYR- cetirizine hydrochloride tablet, film coated

Wal Zyr by

Drug Labeling and Warnings

Wal Zyr by is a Otc medication manufactured, distributed, or labeled by Walgreen Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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. (1-800-222-1222)

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 20-25°C (68-77°F)
• do not use if blister unit is broken or torn

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Principal Display Panel

ORIGINAL PRESCRIPTION STRENGTH

Wal-Zyr™

Compare to Zyrtec® active ingredient

24 HOUR ALLERGY

CETIRIZINE HYDROCHLORIDE TABLETS 10 mg / ANTIHISTAMINE

24 HOUR

TABLETS

INDOOR & OUTDOOR ALLERGIES

24-hour relief of sneezing; runny nose; itchy, watery eyes & itchy throat or nose

24 HOUR

ACTUAL SIZE

5 TABLETS 10 mg EACH

INGREDIENTS AND APPEARANCE

WAL ZYR 
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0495
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0495-13	5 in 1 CARTON	01/31/2008
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0363-0495-06	1 in 1 CARTON	11/06/2013
2		70 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0363-0495-39	1 in 1 CARTON	08/14/2008
3		30 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0363-0495-47	1 in 1 CARTON	05/02/2008
4		150 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 0363-0495-66	14 in 1 CARTON	01/09/2008
5		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 0363-0495-72	1 in 1 CARTON	01/27/2008	09/20/2015
6		60 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 0363-0495-75	1 in 1 CARTON	01/27/2008
7		90 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 0363-0495-87	1 in 1 CARTON	01/21/2010
8		300 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 0363-0495-95	1 in 1 CARTON	01/05/2009
9		45 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 0363-0495-58	1 in 1 CARTON	08/08/2016
10		40 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078336	01/09/2008

Labeler - Walgreen Company (008965063)