说明与适用边界
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spl product data elements
Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl and Pseudoephedrine HCI FEXOFENADINE HYDROCHLORIDE FEXOFENADINE MANNITOL PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE POWDERED CELLULOSE STARCH, CORN CROSCARMELLOSE SODIUM SILICON DIOXIDE FERRIC OXIDE RED MAGNESIUM STEARATE Hypromelloses TRIETHYL CITRATE R;195 off white to pale yellow one layer and light red to red other layer carton30count
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 nasal congestion itchy, watery eyes itching of the nose or throat 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 takeas 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 Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contacta 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 takeas 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
Pregnancy/Breastfeeding 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 contacta 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 this product meets the requirements of USP dissolution test 3.
储存 / Storage and handling
Storage store between 20° to 25°C (68° to 77°F)
辅料 / Inactive ingredients
Inactive ingredients corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose, and triethyl citrate.
questions
Questions or comments? call toll-free 1-888-375-3784 Manufactured by: Dr. Reddy’s Laboratories Limited Bachupally - 500 090 INDIA
package label principal display panel
Principal Display Panel Blister carton 30's (6x5 unit-dose)
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20171207
- 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.

