Label: WAL-ZYR CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution
- NDC Code(s): 0363-2088-02, 0363-2088-05, 0363-2088-08
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL pre-filled vial)
Cetirizine Hydrochloride 5 mgClose
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- itching of the nose or throat
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.
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).
- 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.Close
- SPL UNCLASSIFIED SECTION
DISTRIBUTED BY: WALGREEN CO.Close
200 WILMOT RD., DEERFIELD, IL 60015
- PRINCIPAL DISPLAY PANEL - 10 Vial Carton
WALGREENS PHARMACIST RECOMMENDEDǂ
1 mg/mL / Antihistamine
● Alcohol free ● Gluten free
● 6 years & older
● Sneezing ● Runny nose
● Itchy, watery eyes
● Itchy throat or nose
PRE-FILLED INDIVIDUAL VIALS
Compare to Children's Zyrtec®
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 DEA Schedule 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)