说明与适用边界
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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.

