说明与适用边界
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spl product data elements
nasal decongestant Pseudoephedrine Hydrochloride PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CARNAUBA WAX SILICON DIOXIDE DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE L054
活性成分 / Active ingredient
Active ingredient (in each tablet) Pseudoephedrine HCl 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 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. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dosage Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with a fever If pregnant or breast-feeding, 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 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 styleCode="Noautorules" width="100%"><col width="38%"/><col width="60%"/><tbody><tr><td styleCode="Rrule Botrule Toprule " valign="top"><paragraph>adults and children 12 years and over</paragraph></td><td styleCode="Botrule Lrule Toprule " valign="top"><list listType="ordered"><item><caption>•</caption>take 1 tablet every 12 hours</item><item><caption>•</caption>do not take more than 2 tablets in 24 hours</item></list></td></tr><tr><td styleCode="Rrule Botrule Toprule " valign="top"><paragraph>children under 12 years</paragraph></td><td styleCode="Botrule Lrule Toprule " valign="top"><paragraph>do not use this product in children under 12 years of age</paragraph></td></tr></tbody></table>
储存 / Storage and handling
Other information • each tablet contains: calcium 45 mg • store at 68-77°F (20-25°C) in a dry place • protect from light • do not use if blister unit is broken or torn • see carton end panel for lot number and expiration date • this product meets the requirements of USP Drug Release Test 3
辅料 / Inactive ingredients
Inactive ingredients carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
package label principal display panel
Principal Display Panel Maximum Strength Pseudoephedrine Hydrochloride Extended release tablets, 120mg Nasal Decongestant Sinus • 12 HOUR • Relieves sinus pressure and congestion • Non-drowsy p ACTUAL SIZE 20 Coated caplets* *Capsule-shaped tablets Compare to Sudafed ® Sinus Congestion 12 Hour Caplets active ingredient. nasal-decongestant
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20260401
- 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.