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西药 · 美国药品标签原文

Nasal Decongestant PE

PHENYLEPHRINE HCL

Nasal Decongestant PE · Better Living Brands, 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

Nasal Decongestant PE Phenylephrine HCl PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM DEXTROSE MONOHYDRATE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C RED NO. 40 LECITHIN, SOYBEAN MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED TRISODIUM CITRATE DIHYDRATE TITANIUM DIOXIDE 44;453

活性成分 / Active ingredient

Active ingredient (in each tablet) Phenylephrine HCl 10 mg

用途 / Purpose

Purpose Nasal decongestant

适应证 / Indications and usage

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

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 diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the 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 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.

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 diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the 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 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.

用法用量原文 / Dosage and administration

Directions adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: ask a doctor

储存 / Storage and handling

Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

辅料 / Inactive ingredients

Inactive ingredients croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

questions

Questions or comments? 1-800-426-9391

package label principal display panel

Principal Display Panel Signature SELECT™ COMPARE TO SUDAFED PE® SINUS CONGESTION Active Ingredient † NDC 21130-453-07 MAXIMUM STRENGTH NASAL DECONGESTANT PE PHENYLEPHRINE HCI 10 mg - Nasal Decongestant Relieves: Congestion and sinus pressure Non-drowsy Actual Size 36 TABLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING DISTRIBUTED BY: BETTER LIVING BRANDS LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 ‡ 1-888-723-3929 LOVE IT OR IT'S ON US ‡ † This product is not manufactured or distributed by Kenvue Inc., distributors of SUDAFED PE® SINUS CONGESTION. 50844 REV0820N45307 Signature Select 44-453 Signature Select 44-453

来源、版本与许可

资料类型
美国药品标签原文
版本
21 / 20260306
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