NDC | 0363-0495-06, 0363-0495-13, 0363-0495-39, 0363-0495-47, 0363-0495-58, 0363-0495-66, 0363-0495-72, 0363-0495-75, 0363-0495-87, 0363-0495-95 |
Set ID | 16625a43-22c1-4754-a7bd-ccc262e2dbd5 |
Category | HUMAN OTC DRUG LABEL |
Packager | Walgreen Company |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA078336 |
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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.
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.
-
Directions
adults and children 6 years and over
one 10 mg tablet once daily; do not take more than one 10 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 liver or kidney disease
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
ORIGINAL PRESCRIPTION STRENGTH
Wal-Zyr™
Compare to Zyrtec® active ingredient
24 HOUR ALLERGY
CETIRIZINE HYDROCHLORIDE TABLETS 10 mg / ANTIHISTAMINE
24 HOUR
TABLETS
INDOOR & OUTDOOR ALLERGIES
24-hour relief of sneezing; runny nose; itchy, watery eyes & itchy throat or nose
24 HOUR
ACTUAL SIZE
5 TABLETS 10 mg EACH
-
INGREDIENTS AND APPEARANCE
WAL ZYR
cetirizine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0495 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color WHITE Score no score Shape OVAL Size 10mm Flavor Imprint Code 4H2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0495-13 5 in 1 CARTON 01/31/2008 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0363-0495-06 1 in 1 CARTON 11/06/2013 2 70 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0363-0495-39 1 in 1 CARTON 08/14/2008 3 30 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0363-0495-47 1 in 1 CARTON 05/02/2008 4 150 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0363-0495-66 14 in 1 CARTON 01/09/2008 5 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:0363-0495-72 1 in 1 CARTON 01/27/2008 09/20/2015 6 60 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:0363-0495-75 1 in 1 CARTON 01/27/2008 7 90 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:0363-0495-87 1 in 1 CARTON 01/21/2010 8 300 in 1 BOTTLE; Type 0: Not a Combination Product 9 NDC:0363-0495-95 1 in 1 CARTON 01/05/2009 9 45 in 1 BOTTLE; Type 0: Not a Combination Product 10 NDC:0363-0495-58 1 in 1 CARTON 08/08/2016 10 40 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078336 01/09/2008 Labeler - Walgreen Company (008965063)