WAL-ZYR CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution

Wal-Zyr by

Drug Labeling and Warnings

Wal-Zyr by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceutical Industries Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each 5 mL pre-filled vial)

Cetirizine Hydrochloride 5 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

• medicine should be dispensed directly into mouth using the enclosed pre-filled vial(s).

• adults and children 6 years and over: 1 pre-filled (5 mL) or 2 pre-filled vials (10 mL) once daily depending upon severity of symptoms; do not take more than 2 pre-filled vials (10 mL) in 24 hours.
• adults 65 years and over: 1 pre-filled vial (5 mL) once daily; do not take more than 1 pre-filled vial (5 mL) in 24 hours.
• children under 6 years of age: ask a doctor
• Consumer with liver or kidney disease: ask a doctor

Other information

• store between 20° to 25°C (68° to 77°F)
• Do not use if pouch is torn or damaged. Do not use if twist-off cap is removed or separated from vial.
• See side panel for lot number and expiration date

Inactive ingredients

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucrose.

Questions?

Call 1-866-923-4914

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DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 10 Vial Carton

Well at
Walgreens

WALGREENS PHARMACIST RECOMMENDEDǂ

NDC: 0363-2088-05

NEW
children's
Wal-Zyr™

Cetirizine Hydrochloride
Oral Solution
1 mg/mL / Antihistamine

Allergy

● Alcohol free ● Gluten free
● 6 years & older

Relieves:

● Sneezing ● Runny nose
● Itchy, watery eyes
● Itchy throat or nose

INDOOR &
OUTDOOR
ALLERGIES

24 HOUR
SYMPTOM
RELIEF

DYE
FREE

GRAPE FLAVOR

10
PRE-FILLED INDIVIDUAL VIALS

Compare to Children's Zyrtec®
active ingredientǂǂ

0.17 FL OZ (5 mL) EACH

INGREDIENTS AND APPEARANCE

WAL-ZYR   CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-2088
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24)	Cetirizine Hydrochloride	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
acetic acid (UNII: Q40Q9N063P)
glycerin (UNII: PDC6A3C0OX)
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium acetate anhydrous (UNII: NVG71ZZ7P0)
sucrose (UNII: C151H8M554)

Product Characteristics
Color	YELLOW (colorless to slightly yellow)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-2088-05	10 in 1 CARTON
1		1 in 1 POUCH
1		5 mL in 1 VIAL, SINGLE-DOSE
2	NDC: 0363-2088-08	1 in 1 CARTON
2		120 mL in 1 BOTTLE
3	NDC: 0363-2088-02	1 in 1 CARTON
3		240 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090182	04/22/2008

Labeler - Walgreen Company (008965063)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceutical Industries Ltd.		600072078	MANUFACTURE(0363-2088)