Your browser does not support JavaScript! WAL-ZYR CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [WALGREEN COMPANY]
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WAL-ZYR CETIRIZINE HYDROCHLORIDE (cetirizine hydrochloride) solution
[Walgreen Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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 over1 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 over1 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 ageask a doctor
Consumer with liver or kidney diseaseask 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

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

PRINCIPAL DISPLAY PANEL - 10 Vial Carton
WAL-ZYR   CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-2088
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
acetic acid 
glycerin 
methylparaben 
propylene glycol 
propylparaben 
water 
sodium acetate anhydrous 
sucrose 
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-2088-0510 in 1 CARTON
11 in 1 POUCH
15 mL in 1 VIAL, SINGLE-DOSE
2NDC:0363-2088-081 in 1 CARTON
2120 mL in 1 BOTTLE
3NDC:0363-2088-021 in 1 CARTON
3240 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09018204/22/2008
Labeler - Walgreen Company (008965063)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(0363-2088)

Revised: 1/2013
 
Walgreen Company

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