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西药 · 美国药品标签原文

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride · Rite Aid Corporation。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

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride FEXOFENADINE HYDROCHLORIDE FEXOFENADINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE MICROCRYSTALLINE CELLULOSE 101 Croscarmellose Sodium Ferric Oxide Yellow Silicon Dioxide Magnesium Stearate Polyethylene Glycol 400 Hypromellose 2208 (100000 Mpa.S) HYDROXYPROPYL CELLULOSE (45000 WAMW) Hypromellose 2910 (6 Mpa.S) Polyethylene Glycol 8000 Starch, Corn MICROCRYSTALLINE CELLULOSE 102 one white to off-white color layer and other light yellow to yellow color carton

活性成分 / Active ingredient

Active ingredient(s) Fexofenadine HCl USP, 60 mg Pseudoephedrine HCl USP, 120 mg

用途 / Purpose

Purpose Antihistamine Nasal decongestant

适应证 / Indications and usage

Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relives nasal congestion due to the common cold, hay fever or other upper respiratory allergies 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 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. if you have difficulty swallowing Ask a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions). Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever you get nervous, dizzy, or sleepless 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 have ever had an allergic reaction to this product or any of its ingredients 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. if you have difficulty swallowing

咨询医生 / Ask a doctor

Ask a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease. Your doctor should determine if you need a different dose.

使用中 / When using

When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

停用事项 / Stop use

Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever you get nervous, dizzy, or sleepless

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 do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

dosage and administration table

<table border="1" cellpadding="0" cellspacing="0"><tbody><tr><td valign="top">adults and children 12 years of age and over <content styleCode="bold"/></td><td valign="top">take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours</td></tr><tr><td valign="top">children under 12 years of age</td><td valign="top">do not use</td></tr><tr><td valign="top">adults 65 years of age and older</td><td valign="top">ask a doctor</td></tr><tr><td valign="top">consumers with kidney disease</td><td valign="top">ask a doctor</td></tr></tbody></table>

spl unclassified section

Other information safety sealed: do not use if carton is opened or if individual blister units are torn or opened store between 20° to 25°C (68° to 77°F) store between 20° to 25°C (68° to 77°F) FDA approved dissolution test specifications differ from USP. FDA approved organic impurities test procedure differs from USP Procedure 1.

辅料 / Inactive ingredients

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, ferric oxide (iron oxide yellow), HPMC 2910 / hypromellose (6 Cps), hydroxypropyl cellulose, hypromellose (methocel K100M DC2), macrogol (polyethylene glycol MW 400), macrogol (polyethylene glycol MW 8000), magnesium stearate, microcrystalline cellulose (avicel PH 101), microcrystalline cellulose (avicel PH102), pregelatinized starch.

questions

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来源、版本与许可

资料类型
美国药品标签原文
版本
5 / 20251210
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