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西药 · 美国药品标签原文

cetirizine hydrochloride

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride · Bryant Ranch Prepack。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 ACETIC ACID GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM ACETATE SUCROSE Pale Yellow

活性成分 / Active ingredient

Active ingredient (in each 5 mL) Cetirizine HCl 5 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 • 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. 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)

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 • 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 • use only with enclosed dosing cup • find right dose on chart below • mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

dosage and administration table

<table width="100%"><col width="32%"/><col width="68%"/><tbody><tr><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>adults and children</paragraph><paragraph>6 years and over</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.</paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>adults 65 years</paragraph><paragraph>and over</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>5 mL once daily; do not take more than 5 mL in 24 hours.</paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>children 2 to under</paragraph><paragraph>6 years of age</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.</paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>children under</paragraph><paragraph>2 years of age</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>ask a doctor</paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>consumers with liver or kidney disease</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>

储存 / Storage and handling

Other information • store between 20 ° to 25 ° C (68 ° to 77 ° F) • do not use if carton is opened, or if printed neckband is broken or missing • see bottom panel for lot number and expiration date

辅料 / Inactive ingredients

Inactive ingredients artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

questions

Questions or comments? 1-800-719-9260

包装供应 / How supplied

HOW SUPPLIED Children’s Cetirizine Hydrochloride Oral Solution 1 mg/mL NDC 72162-2339-2: 118 mL in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

package label principal display panel

Children’s Cetirizine Hydrochloride Oral Solution 1 mg/mL Extended Label Label extended label

来源、版本与许可

资料类型
美国药品标签原文
版本
2 / 20250403
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