Label: ZYRTEC ALLERGY- cetirizine hydrochloride tablet, film coated
-
NDC Code(s):
50580-726-03,
50580-726-05,
50580-726-13,
50580-726-25, view more50580-726-30, 50580-726-32, 50580-726-36, 50580-726-38, 50580-726-40, 50580-726-50, 50580-726-51, 50580-726-66, 50580-726-70, 50580-726-90, 50580-726-91, 50580-726-92, 50580-726-93, 50580-726-94, 50580-726-95, 50580-726-96, 50580-726-97
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated May 19, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZYRTEC ALLERGY
cetirizine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-726 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score 2 pieces Shape RECTANGLE (rounded-off rectangular biconvex tablet) Size 9mm Flavor Imprint Code ZYRTEC;10;MG Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-726-03 50 in 1 CARTON 01/01/2008 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:50580-726-13 3 in 1 CARTON 03/21/2009 01/31/2021 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:50580-726-30 5 in 1 PACKAGE 01/01/2008 11/30/2022 3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:50580-726-32 14 in 1 PACKAGE 01/01/2008 11/30/2022 4 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:50580-726-36 1 in 1 PACKAGE 01/01/2008 5 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 6 NDC:50580-726-50 1 in 1 PACKAGE 01/26/2010 6 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 7 NDC:50580-726-51 2 in 1 PACKAGE 01/26/2010 11/30/2022 7 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 8 NDC:50580-726-38 1 in 1 PACKAGE 01/01/2008 12/31/2022 8 45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 9 NDC:50580-726-70 1 in 1 PACKAGE 01/01/2008 12/31/2022 9 70 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10 NDC:50580-726-90 2 in 1 PACKAGE 01/26/2010 10 45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11 NDC:50580-726-66 75 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 01/01/2008 12 NDC:50580-726-40 1 in 1 PACKAGE 01/20/2014 12 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 13 NDC:50580-726-91 2500 in 1 CARTON 07/27/2018 13 1 in 1 POUCH; Type 0: Not a Combination Product 14 NDC:50580-726-92 50 in 1 TRAY 07/12/2018 14 1 in 1 POUCH; Type 0: Not a Combination Product 15 NDC:50580-726-93 3 in 1 CARTON 07/27/2018 15 1 in 1 POUCH; Type 0: Not a Combination Product 16 NDC:50580-726-94 1 in 1 PACKAGE 06/15/2020 16 60 in 1 BOTTLE; Type 0: Not a Combination Product 17 NDC:50580-726-95 1 in 1 PACKAGE 06/15/2020 17 90 in 1 BOTTLE; Type 0: Not a Combination Product 18 NDC:50580-726-96 5 in 1 CARTON 05/30/2020 18 1 in 1 POUCH; Type 0: Not a Combination Product 19 NDC:50580-726-97 14 in 1 CARTON 05/30/2020 19 1 in 1 POUCH; Type 0: Not a Combination Product 20 NDC:50580-726-05 2500 in 1 CASE 03/01/2023 20 1 in 1 POUCH; Type 0: Not a Combination Product 21 NDC:50580-726-25 50 in 1 CARTON 03/01/2023 21 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019835 01/01/2008 Labeler - Johnson & Johnson Consumer Inc. (878046358)