Label: ZYRTEC- cetirizine hydrochloride capsule, liquid filled
- NDC Code(s): 50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65
- Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Category: HUMAN OTC DRUG LABEL
Updated December 11, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each capsule)
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.
adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule 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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
cetirizine hydrochloride capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-779 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 gelatin, unspecified (UNII: 2G86QN327L) glycerin (UNII: PDC6A3C0OX) mannitol (UNII: 3OWL53L36A) polyethylene glycol 400 (UNII: B697894SGQ) water (UNII: 059QF0KO0R) sodium hydroxide (UNII: 55X04QC32I) sorbitan (UNII: 6O92ICV9RU) sorbitol (UNII: 506T60A25R) Product Characteristics Color YELLOW (Clear) Score no score Shape OVAL Size 14mm Flavor Imprint Code Z10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-779-12 1 in 1 PACKAGE 02/08/2010 1 12 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:50580-779-25 1 in 1 PACKAGE 02/08/2010 2 25 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:50580-779-40 1 in 1 PACKAGE 02/08/2010 3 40 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:50580-779-65 65 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 02/08/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022429 02/08/2010 Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)