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西药 · 美国药品标签原文

FLONASE SENSIMIST ALLERGY RELIEF

FLUTICASONE FUROATE

FLONASE SENSIMIST ALLERGY RELIEF · Haleon US Holdings 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

FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate FLUTICASONE FUROATE FLUTICASONE BENZALKONIUM CHLORIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS DEXTROSE EDETATE DISODIUM MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 WATER

活性成分 / Active ingredient

Active ingredient (in each spray) Fluticasone furoate 27.5 mcg (glucocorticoid)* *read the Question & Answer Book

用途 / Purpose

Purpose Allergy symptom reliever

适应证 / Indications and usage

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes (for ages 12 and older)

警告 / Warnings

Warnings Only for use in the nose. Do not spray into your eyes or mouth. Do not use • in children under 2 years of age • to treat asthma • if you have an injury or surgery to your nose that is not fully healed • if you have ever had an allergic reaction to this product or any of the ingredients Ask a doctor before use if you have or had glaucoma or cataracts Ask a doctor or pharmacist before use if you are taking • medicine for HIV infection (such as ritonavir) • a steroid medicine for asthma, allergies or skin rash • ketoconazole pills (medicine for fungal infection) When using this product • the growth rate of some children may be slower • stinging or sneezing may occur for a few seconds right after use • do not share this bottle with anyone else as this may spread germs • remember to tell your doctor about all the medicines you take, including this one Stop use and ask a doctor if • you have, or come into contact with someone who has, chicken pox, measles or tuberculosis • your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection. • you get a constant whistling sound from your nose. This may be a sign of damage inside your nose. • you get an allergic reaction to this product. Seek medical help right away. • you get new changes to your vision that develop after starting this product • you have severe or frequent nosebleeds 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 • in children under 2 years of age • to treat asthma • if you have an injury or surgery to your nose that is not fully healed • if you have ever had an allergic reaction to this product or any of the ingredients

咨询医生 / Ask a doctor

Ask a doctor before use if you have or had glaucoma or cataracts

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are taking • medicine for HIV infection (such as ritonavir) • a steroid medicine for asthma, allergies or skin rash • ketoconazole pills (medicine for fungal infection)

使用中 / When using

When using this product • the growth rate of some children may be slower • stinging or sneezing may occur for a few seconds right after use • do not share this bottle with anyone else as this may spread germs • remember to tell your doctor about all the medicines you take, including this one

停用事项 / Stop use

Stop use and ask a doctor if • you have, or come into contact with someone who has, chicken pox, measles or tuberculosis • your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection. • you get a constant whistling sound from your nose. This may be a sign of damage inside your nose. • you get an allergic reaction to this product. Seek medical help right away. • you get new changes to your vision that develop after starting this product • you have severe or frequent nosebleeds

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 • read the Quick Start Guide for how to: • shake vigorously before each use • prime the bottle • use the spray • sniff gently after each spray • clean the spray nozzle with a clean dry tissue • use this product only once a day • do not use more than directed ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER • Week 1 – use 2 sprays in each nostril once daily • Week 2 through 6 months – use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms • After 6 months of daily use – ask your doctor if you can keep using CHILDREN 2 TO 11 YEARS OF AGE • the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. • an adult should supervise use • use 1 spray in each nostril once daily CHILDREN UNDER 2 YEARS OF AGE • do not use

储存 / Storage and handling

Other information • you may start to feel relief the first day and full effect after several days of regular, once-a-day use • store between 15° – 30°C (59° – 86°F) • do not refrigerate or freeze • keep this label and enclosed materials. They contain important additional information.

辅料 / Inactive ingredients

Inactive ingredients benzalkonium chloride solution, carboxymethylcellulose sodium, dextrose anhydrous, edetate disodium, microcrystalline cellulose, polysorbate 80, purified water

questions

Questions or comments? call toll-free 1-844-FLONASE (1-844-356-6273)

spl unclassified section

Generic Section FLONASE SENSIMIST ALLERGY RELIEF What problems can FLONASE SENSIMIST Allergy Relief help with? FLONASE SENSIMIST Allergy Relief helps relieve a broad range of uncomfortable symptoms like congestion and itchy eyes*. Nasal symptoms Eye symptoms* *for ages 12 and older. These symptoms can be triggered by allergens like pollen, mold, dust or pet dander. Outdoor allergens Animal allergens Indoor allergens IMPORTANT – Peel here for complete Drug Facts label. Children 2-11: do not use for more than 2 months a year. Be sure to read the Quick Start Guide and Question & Answer Book inside package TAMPER-EVIDENT features for your protection. The product is packaged in a sealed plastic container. The bottle is housed within a plastic dispenser that prevents direct access to the bottle. Do not use if the container or any part of the plastic dispenser, including the dispenser bottom, is damaged or broken.

package label principal display panel

Principal Display Panel FLONASE SENSIMIST ALLERGY RELIEF Fluticasone Furoate Nasal Spray 27.5 mcg Per Spray Allergy Symptom Reliever (Glucocorticoid)* Non-Drowsy Relief of: • Nasal congestion • itchy, watery eyes • Itchy nose • Runny nose • Sneezing FULL PRESCRIPTION STRENGTH 24 HOUR RELIEF 120 METERED SPRAYS *Fluticasone furoate is a steroid medicine known as a glucocorticoid. 0.31 fl oz (9.1 mL) Flonase Sensimist 120 sprays

来源、版本与许可

资料类型
美国药品标签原文
版本
11 / 20241219
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