说明与适用边界
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spl product data elements
Allergy relief-D Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STEARIC ACID TITANIUM DIOXIDE AMMONIA FERROSOFERRIC OXIDE ISOPROPYL ALCOHOL BUTYL ALCOHOL PROPYLENE GLYCOL SHELLAC HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) circular 915
spl unclassified section
Drug Facts
Distributed By: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087
活性成分 / Active ingredient
Active ingredients (in each extended-release tablet) Purpose Cetirizine HCl, USP 5 mg Antihistamine Pseudoephedrine HCl, USP 120 mg Nasal Decongestant
active ingredient table
<table width="75%"> <col width="60%" align="left" valign="top"/> <col width="40%" align="right" valign="top"/> <thead> <tr> <th> <content styleCode="italics">Active ingredients (in each extended-release tablet)</content> </th> <th> <content styleCode="italics">Purpose</content> </th> </tr> </thead> <tbody> <tr> <td valign="bottom">Cetirizine HCl, USP 5 mg</td> <td valign="bottom">Antihistamine</td> </tr> <tr> <td valign="bottom">Pseudoephedrine HCl, USP 120 mg</td> <td valign="bottom">Nasal Decongestant</td> </tr> </tbody> </table>
用途 / Purpose
Active ingredients (in each extended-release tablet) Purpose Cetirizine HCl, USP 5 mg Antihistamine Pseudoephedrine HCl, USP 120 mg Nasal Decongestant
purpose table
<table width="75%"> <col width="60%" align="left" valign="top"/> <col width="40%" align="right" valign="top"/> <thead> <tr> <th> <content styleCode="italics">Active ingredients (in each extended-release tablet)</content> </th> <th> <content styleCode="italics">Purpose</content> </th> </tr> </thead> <tbody> <tr> <td valign="bottom">Cetirizine HCl, USP 5 mg</td> <td valign="bottom">Antihistamine</td> </tr> <tr> <td valign="bottom">Pseudoephedrine HCl, USP 120 mg</td> <td valign="bottom">Nasal Decongestant</td> </tr> </tbody> </table>
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 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) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks af ter 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. at 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) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks af ter 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
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. at 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 width="50%"> <col width="50%" align="left" valign="top"/> <col width="50%" align="left" valign="top"/> <tbody> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">adults and children 12 years and over</td> <td styleCode="Rrule">take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">adults 65 years and over</td> <td styleCode="Rrule">ask a doctor</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">children under 12 years of age</td> <td styleCode="Rrule">ask a doctor</td> </tr> <tr> <td styleCode="Lrule Rrule">consumers with liver or kidney disease</td> <td styleCode="Rrule">ask a doctor</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 the blister unit is broken see side panel for batch number and expiration date
辅料 / Inactive ingredients
Inactive ingredients hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze
questions
Questions? Call toll free 1-800-818-4555 weekdays
package label principal display panel
PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton *COMPARE TO THE ACTIVE INGREDIENTS IN ZYRTEC-D 12 HOUR ® Original Prescription Strength Premier Value ® Allergy & Congestion Relief Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, USP 5 mg/120 mg Antihistamine/Nasal Decongestant Indoor & Outdoor Allergies 12 Hour Relief of: ✓ Runny Nose ✓ Itchy Throat or Nose ✓ Sneezing ✓ Sinus Pressure ✓ Itchy, Watery Eyes ✓ Nasal Congestion 24 TABLETS (4 blister cards of 6 tablets each) INDEPENDENTLY TESTED PV SATISFACTION GUARANTEED Principal Display Panel - 24 Tablet Blister Pack Carton
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 1 / 20181130
- 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.

