Children 6 months to <2 years The recommended dose of ZYRTEC syrup in children 6 months to 23 months of age is 2.5 mg (˝ teaspoon) once daily. The dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day, given as ˝ teaspoonful (2.5 mg) every 12 hours. Dose Adjustment for Renal and Hepatic Impairment In patients 12 years of age and older with decreased renal function (creatinine clearance 11-31 mL/ min), patients on hemodialysis (creatinine clearance less than 7 mL/ min), and in hepatically impaired patients, a dose of 5 mg once daily is recommended. Similarly, pediatric patients aged 6 to 11 years with impaired renal or hepatic function should use the lower recommended dose. Because of the difficulty in reliably administering doses of less than 2.5 mg (˝ teaspoon) of ZYRTEC syrup and in the absence of pharmacokinetic and safety information for cetirizine in children below the age of 6 years with impaired renal or hepatic function, its use in this impaired patient population is not recommended. HOW SUPPLIED ZYRTEC® tablets are white, film-coated, rounded-off rectangular shaped containing 5 mg or 10 mg cetirizine hydrochloride. 5 mg tablets are engraved with "ZYRTEC" on one side and "5" on the other. Bottles of 100: NDC 0069-5500-66 10 mg tablets are engraved with "ZYRTEC" on one side and "10" on the other. Bottles of 100: NDC 0069-5510-66 STORAGE: Store at 20 ° ° ° -25 ° ° ° C (68 ° ° ° -77 ° ° ° F) excursions permitted to 15 -30 C (59 -86 F) [see USP Controlled Room Temperature]. ZYRTEC® syrup is colorless to slightly yellow with a banana-grape flavor. Each teaspoonful (5 mL) contains 5 mg cetirizine hydrochloride. ZYRTEC® syrup is supplied as follows: 120 mL amber glass bottles NDC 0069-5530-47 1 pint amber glass bottles NDC 0069-5530-93 STORAGE: Store at 20 ° ° ° -25 ° ° ° C (68 ° ° ° -77 ° ° ° F) excursions permitted to 15 -30 C (59 -86 F) [see USP Controlled Room Temperature]; or Store refrigerated, 2 ° ° ° -8 ° ° ° C (36 ° ° ° -46 ° ° ° F). Cetirizine is licensed from UCB Pharma, Inc. Rx only 2003 PFIZER INC Manufactured/ Marketed by Marketed by UCB Pharma, Inc. Smyrna, GA 30080 70-4573-00-7 Revised August 2003 Pfizer Labs Division of Pfizer Inc, NY, NY 10017 | ||||
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