Label: ZYRTEC ALLERGY- cetirizine hydrochloride tablet, film coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 52904-961-03 - Packager: Select Corporation
- This is a repackaged label.
- Source NDC Code(s): 50580-726
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated April 21, 2022
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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Blister Pack
-
INGREDIENTS AND APPEARANCE
ZYRTEC ALLERGY
cetirizine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-961(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:52904-961-03 1 in 1 BLISTER PACK 01/01/2008 1 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 - Select Corporation (053805599)