说明与适用边界
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spl product data elements
Cetirizine Hydrochloride (Allergy) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE FERROSOFERRIC OXIDE GELATIN, UNSPECIFIED GLYCERIN HYPROMELLOSE 2910 (6 MPA.S) POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL WATER SODIUM HYDROXIDE SORBITOL Clear colourless to pale yellow viscous liquid CZ10
spl unclassified section
Cetirizine HCl Capsules 10 mg (Allergy) Drug Facts
活性成分 / Active ingredient
Active ingredient (in each capsule) Cetirizine HCl USP 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.
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 avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness 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. (1-800-222-1222)
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 cellspacing="0" cellpadding="0" border="0" width="100%"><colgroup><col width="58%"/><col width="41%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">adults and children 6 years and over </td><td styleCode="Rrule" valign="top">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 styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">adults 65 years and over </td><td styleCode="Rrule" valign="top">ask a doctor </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">children under 6 years of age </td><td styleCode="Rrule" valign="top">ask a doctor </td></tr><tr><td styleCode="Lrule Rrule" valign="top">consumers with liver or kidney disease </td><td styleCode="Rrule" valign="top">ask a doctor </td></tr></tbody></table>
储存 / Storage and handling
Other information store at 20°-25°C (68°-77°F) avoid high humidity and excessive heat above 40°C (104°F) protect from light do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.
辅料 / Inactive ingredients
Inactive ingredients black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution
questions
Questions or comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/16/2014
package label principal display panel
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (40's Capsule Container Label) PrimaryHealth NDC 58602-863-12 ALLERGY Original Prescription Strength Cetirizine HCl Capsules 10 mg Antihistamine INDOOR + OUTDOOR ALLERGIES 40 LIQUID GELS* * LIQUID-FILLED CAPSULES PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (40's Capsule Container Carton Label) NDC 58602-863-12 PrimaryHealth COMPARE TO Zyrtec ® active ingredient * Original Prescription Strength ALLERGY Cetirizine HCl Capsules 10 mg Antihistamine INDOOR +OUTDOOR ALLERGIES 24 HOUR RELIEF OF Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose CZ10 (Actual size) 40 LIQUID GELS* * LIQUID-FILLED CAPSULES PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12's Capsule Container Carton Label)
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 1 / 20210311
- 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.

