Wal-Zyr: Package Insert and Label Information

WAL-ZYR- cetirizine hydrochloride tablet
Walgreen Company

10 mg-Bottle-label-45count10 mg-Carton-label-45count

Active ingredients (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 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 one10 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 liveror kidney disease ask a doctor

Other information

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

Inactive ingredients

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

Questions

1-800-706-5575

* This product is not manufactured or distributed by McNeil-PPC, Inc., distributor ofZyrtec®.

Principal Display Panel — 10 mg-Bottle-label-45count

OTC Medicine

Walgreens

Wal-ZyrTM

NDC# 0363-1024-04

24 Hour Allergy

Antihistamine

  • 24 hour symptom relief

45 TABLETS 10 mg each

10 mg-Bottle-label-45count
(click image for full-size original)

Principal Display Panel — 10 mg-Carton-label-45count

OTC Medicine

Walgreens

Wal-ZyrTM

Carton

NDC# 0363-1024-04

24 Hour Allergy

Antihistamine

  • 24 hour symptom relief

45 TABLETS 10 mg each

10 mg-Carton-label-45count
(click image for full-size original)
WAL-ZYR
wal-zyr tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1024
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
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
CARNAUBA WAX
Product Characteristics
Color WHITE Score no score
Shape RECTANGLE Size 9mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-1024-04 1 BOTTLE in 1 CARTON contains a BOTTLE
1 45 TABLET in 1 BOTTLE This package is contained within the CARTON (0363-1024-04)
2 NDC:0363-1024-07 1 BOTTLE in 1 CARTON contains a BOTTLE
2 70 TABLET in 1 BOTTLE This package is contained within the CARTON (0363-1024-07)
3 NDC:0363-1024-01 1 BOTTLE in 1 CARTON contains a BOTTLE
3 150 TABLET in 1 BOTTLE This package is contained within the CARTON (0363-1024-01)
4 NDC:0363-1024-03 1 BOTTLE in 1 CARTON contains a BOTTLE
4 300 TABLET in 1 BOTTLE This package is contained within the CARTON (0363-1024-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078317 09/02/2014 04/30/2021
Labeler — Walgreen Company (008965063)
Registrant — Apotex Inc. (209429182)
Establishment
Name Address ID/FEI Operations
Apotex Inc. 209429182 manufacture (0363-1024), analysis (0363-1024)

Revised: 06/2019 Walgreen Company

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