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西药 · 美国药品标签原文

伪麻黄碱 · Pseudoephedrine HCl

PSEUDOEPHEDRINE HCL

Pseudoephedrine HCl · Aurohealth 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

此页按所列地区、版本归档。标签内容可能更新,具体产品请核对原始来源;本站关联表示阅读线索,不表示药品与器械可兼容或可替换。

spl product data elements

Pseudoephedrine HCl Pseudoephedrine HCl PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYDROXYPROPYL CELLULOSE (90000 WAMW) HYPROMELLOSE 2208 (15000 MPA.S) HYPROMELLOSE 2208 (4000 MPA.S) HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE TALC TITANIUM DIOXIDE White to Off-white 70;T

spl unclassified section

Drug Facts

活性成分 / Active ingredient

Active ingredient (in each tablet) Pseudoephedrine HCl USP 120 mg

用途 / Purpose

Purpose Nasal decongestant

适应证 / Indications and usage

Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure

警告 / Warnings

Warnings

禁用事项 / Do not use

Do not use 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 high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland

使用中 / When using

When using this product do not exceed recommended dosage

停用事项 / Stop use

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever

孕哺期 / Pregnancy or breastfeeding

If pregnant or breast-feeding, 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 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age

dosage and administration table

<table cellspacing="0" cellpadding="0" border="0" width="100%"><colgroup><col width="34%"/><col width="65%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">adults and children 12 years and over<content styleCode="bold"><content styleCode="italics"/></content> </td><td styleCode="Rrule" valign="top"><list listType="unordered" styleCode="disc"><item>take 1 tablet every 12 hours </item><item>do not take more than 2 tablets in 24 hours<content styleCode="bold"><content styleCode="italics"/></content></item></list></td></tr><tr><td styleCode="Lrule Rrule" valign="top">children under 12 years<content styleCode="bold"><content styleCode="italics"/></content> </td><td styleCode="Rrule" valign="top">do not use this product in children under 12 years of age </td></tr></tbody></table>

储存 / Storage and handling

Other information Each tablet contains: calcium 36 mg store at 20° to 25°C (68° to 77°F). Protect from light. do not use if the individual blister unit is open or torn see side panel for lot number and expiration date Meets USP dissolution test 4

辅料 / Inactive ingredients

Inactive ingredients colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide.

questions

Questions or comments? call 1-855-274-4122 Distributed by: AUROHEALTH LLC 2572 Brunswick Pike Lawrenceville, NJ 08648 Made in India Code: TS/DRUGS/22/2009

package label principal display panel

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets AUROHEALTH Compare to the active ingredient in Sudafed ® 12 Hour** NDC 58602-804-67 MAXIMUM STRENGTH Long-Acting Nasal Decongestant Pseudoephedrine HCl Extended-Release Tablets USP 120 mg • SINUS PRESSURE • CONGESTION • NON-DROWSY 12 HOUR 20 COATED CAPLETS* 120 mg EACH *CAPSULE-SHAPED TABLETS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets

来源、版本与许可

资料类型
美国药品标签原文
版本
3 / 20221103
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