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西药 · 美国药品标签原文

Cetirizine Hydrochloride

CETIRIZINE HYDROCHLORIDE

Cetirizine Hydrochloride · Proficient Rx LP。此记录对应特定产品,标签收录不代表所有用途获批。

说明与适用边界

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spl product data elements

Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine HYPROMELLOSE, UNSPECIFIED LACTOSE, UNSPECIFIED FORM magnesium stearate starch, corn POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED titanium dioxide White Barrel Shaped CTN;10

活性成分 / Active ingredient

ACTIVE INGREDIENTS Active Ingredients (in each tablet) Purpose Cetirizine HCl USP 10 mg................................................................Antihistimine

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 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 DOCTOR/PHARMACIST Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

使用中 / When using

WHEN USING THIS PRODUCT • drowsines may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinary.

停用事项 / Stop use

STOP USE Stop use and ask a doctor if an allergic reaction tothis 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 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 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

dosage and administration table

<table cellpadding="0pt" cellspacing="0pt" width="100%"> <col width="49%"/> <col width="49%"/> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>Adults and children 6 years and over</paragraph> </td> <td styleCode="Rrule Botrule Toprule " valign="top"> <paragraph>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.</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Adults 65 years and over</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph>Ask a doctor</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Children under 6 years of age</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph>Ask a doctor</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>Consumers with liver or kidney disease</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph>Ask a doctor</paragraph> </td> </tr> </tbody> </table>

spl unclassified section

OTHER INFORMATION store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] Manufactured by: Unique Pharmaceutical Labs. (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 M. L. G/1430 May 2018 Repackaged by: Proficient Rx LP. Thousand Oaks, CA 91320 120005

辅料 / Inactive ingredients

INACTIVE INGREDIENTS Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

questions

QUESTIONS? Call 1-866-562-4597

package label principal display panel

PRINCIPAL DISPLAY PANEL-30'S COUNT ———PRINCIPAL DISPLAY PANEL——— 71205-164-30 Original Prescription Strength Cetirizine Hydrochloride Tablets USP 10 mg 6 yrs & older 30 Tablets 71205-164-30

来源、版本与许可

资料类型
美国药品标签原文
版本
2 / 20191001
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.
核对原始来源