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西药 · 美国药品标签原文

topcare all day allergy d

CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

topcare all day allergy d · Topco Associates LLC。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

topcare all day allergy d cetirizine hydrochloride, pseudoephedrine hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE L147

活性成分 / Active ingredient

Active ingredients (in each extended release tablet) Cetirizine HCl 5 mg Pseudoephedrine HCl 120 mg

用途 / Purpose

Purpose Antihistamine Nasal decongestant

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 • nasal congestion • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose

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. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • heart disease • thyroid disease • diabetes • glaucoma • high blood pressure • trouble urinating due to an enlarged prostate gland • 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 • do not use more than directed • 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. • you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever 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. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

咨询医生 / Ask a doctor

Ask a doctor before use if you have • heart disease • thyroid disease • diabetes • glaucoma • high blood pressure • trouble urinating due to an enlarged prostate gland • 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 • do not use more than directed • 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. • you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever

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 • do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

dosage and administration table

<table styleCode="Noautorules" width="100%"><col width="50%"/><col width="50%"/><tbody><tr><td styleCode="Rrule Botrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption>adults and children 12 years and over</item></list></td><td styleCode="Botrule Lrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption>take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.</item></list></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><list listType="unordered"><item><caption> </caption>adults 65 years and over</item></list></td><td styleCode="Lrule Toprule Botrule " valign="top"><list listType="unordered"><item><caption> </caption>ask a doctor</item></list></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><list listType="unordered"><item><caption> </caption>children under 12 years of age</item></list></td><td styleCode="Lrule Toprule Botrule " valign="top"><list listType="unordered"><item><caption> </caption>ask a doctor</item></list></td></tr><tr><td styleCode="Rrule Botrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption>consumers with liver or kidney disease</item></list></td><td styleCode="Botrule Lrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption>ask a doctor</item></list></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 blister unit is broken or torn • see side panel for lot number and expiration date • meets USP Dissolution Test 2

辅料 / Inactive ingredients

Inactive ingredients colloidal silicon dioxide, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

questions

Questions or comments? 1-888-423-0139

package label principal display panel

Package/Label Principal Display Panel TopCare ® health COMPARE TO ZYRTEC-D ® ACTIVE INGREDIENTS ORIGINAL PRESCRIPTION STRENGTH ALLERGY & SINUS All Day Allergy-D CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE TABLETS, 5 mg/120 mg INDOOR & OUTDOOR ALLERGIES 12 HOUR RELIEF NASAL CONGESTION + SINUS PRESSURE • Sneezing • Itchy, Watery Eyes • Runny Nose • Itchy Nose or Throat 24 EXTENDED RELEASE TABLETS actual size topcare-all-day-allergy-d-carton-image.jpg

来源、版本与许可

资料类型
美国药品标签原文
版本
5 / 20250212
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