说明与适用边界
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spl product data elements
Cetirizine HCl Cetirizine HCl FD&C YELLOW NO. 6 GELATIN GLYCERIN MANNITOL POLYETHYLENE GLYCOL, UNSPECIFIED WATER SODIUM HYDROXIDE SORBITAN SORBITOL CETIRIZINE HYDROCHLORIDE CETIRIZINE CE1
活性成分 / Active ingredient
Active ingredient (in each capsule) Cetirizine HCl 10 mg
用途 / Purpose
Purpose Antihistamine
适应证 / Indications and usage
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
警告 / Warnings
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. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks 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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
禁用事项 / Do not use
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.
咨询医生 / Ask a doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
咨询医药人员 / Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
使用中 / When using
When using this product drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery
停用事项 / Stop use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use
儿童安全 / Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
用法用量原文 / Dosage and administration
Directions 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
dosage and administration table
<table width="341px"><colgroup><col width="1px"/><col width="1px"/></colgroup><tbody><tr><td styleCode="Botrule Rrule Toprule">adults and children 6 years and over</td><td styleCode="Botrule Toprule">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.</td></tr><tr><td styleCode="Botrule Rrule">adults 65 years and over</td><td styleCode="Botrule"> ask a doctor</td></tr><tr><td styleCode="Botrule Rrule">children under 6 years of age</td><td styleCode="Botrule"> ask a doctor</td></tr><tr><td styleCode="Botrule Rrule">consumers with liver or kidney disease</td><td styleCode="Botrule"> ask a doctor</td></tr></tbody></table>
储存 / Storage and handling
Other information store at 20º-25ºC (68º-77ºF) avoid high humidity and excessive heat above 40ºC (104ºF) protect from light
辅料 / Inactive ingredients
Inactive ingredients FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol
questions
Questions or comments? call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
spl unclassified section
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION † This product is not manufactured or distributed by the owners of Zyrtec ® . Distributed by: NORTHEAST PHARMA Williston, VT 05495 www.heartlandpharmaco.com 1-800-383-0648 R0723 L0000737 T00103R0723
package label principal display panel
Principal Display Panel Compare to active ingredient in Zyrtec ®† Heartland Pharma Co. Cetirizine HCl capsules, 10 mg Antihistamine Indoor & Outdoor Allergies 24 hour relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 25 Softgels** (**liquid-filled capsules) 65's carton
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 1 / 20230926
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

