Wal-zyr
FDA Label NDC 0363-2088

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Wal-zyr (NDC 0363-2088). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml pre-filled vial), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

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

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

Otc - Do Not Use

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.

Otc - Ask Doctor

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Otc - Ask Doctor/Pharmacist

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

Otc - Stop Use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use

Otc - Keep Out Of Reach Of Children

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

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)

Principal Display Panel (10 Vial Carton)

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