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西药 · 美国药品标签原文

布地奈德 · Budesonide

BUDESONIDE

Budesonide · Rugby Laboratories。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

Budesonide Budesonide BUDESONIDE Budesonide EDETATE DISODIUM CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED MICROCRYSTALLINE CELLULOSE DEXTROSE, UNSPECIFIED FORM POTASSIUM SORBATE POLYSORBATE 80 HYDROCHLORIC ACID WATER Bottle-label-120ms Carton-label-120ms

活性成分 / Active ingredient

Active ingredient (in each spray) Budesonide (glucocorticoid) 32 mcg

用途 / Purpose

Purpose Nasal allergy symptom reliever

适应证 / Indications and usage

Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • itchy nose • sneezing

警告 / Warnings

Warnings Do not use in children under 6 years of age if you have ever had an allergic reaction to any of the ingredients Ask a doctor before use if you have had recent nose ulcers or nose surgery have had a nose injury that has not healed are using a steroid medicine for asthma, allergies or skin rash have an eye infection have or had glaucoma or cataracts When using this product the growth rate of some children may be slower some symptoms may get better on the first day of treatment. It may take up to two weeks of daily use to feel the most symptom relief. 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, chickenpox, measles or tuberculosis you have or develop symptoms of an infection such as persistent fever you have any change in vision 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 (1-800-222-1222).

禁用事项 / Do not use

Do not use in children under 6 years of age if you have ever had an allergic reaction to any of the ingredients

咨询医生 / Ask a doctor

Ask a doctor before use if you have had recent nose ulcers or nose surgery have had a nose injury that has not healed are using a steroid medicine for asthma, allergies or skin rash have an eye infection have or had glaucoma or cataracts

使用中 / When using

When using this product the growth rate of some children may be slower some symptoms may get better on the first day of treatment. It may take up to two weeks of daily use to feel the most symptom relief. 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, chickenpox, measles or tuberculosis you have or develop symptoms of an infection such as persistent fever you have any change in vision 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 (1-800-222-1222).

用法用量原文 / Dosage and administration

Directions Read insert (inside package) on how to: get a new bottle ready (primed) before first use prime bottle again if not used for two days use the spray clean the spray nozzle ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER adults and children 12 years of age and older once daily, spray 2 times into each nostril while sniffing gently once your allergy symptoms improve, reduce to 1 spray in each nostril per day CHILDREN 6 TO UNDER 12 YEARS OF AGE the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year children 6 to under 12 years of age an adult should supervise use once daily, spray 1 time into each nostril while sniffing gently if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day children under 6 years of age do not use do not use more than directed if you forget a dose, do not double the next dose do not spray into eyes or mouth if allergy symptoms do not improve after two weeks, stop using and talk to a doctor do not use for the common cold shake well before each use

dosage and administration table

<table frame="below" width="50%"><tbody><tr><td colspan="2"><paragraph><content styleCode="bold">ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER</content></paragraph><paragraph/></td></tr><tr><td><paragraph>adults and children 12 years of age and older</paragraph></td><td><list><item>once daily, spray 2 times into each nostril while sniffing gently</item><item>once your allergy symptoms improve, reduce to 1 spray in each nostril per day</item></list></td></tr><tr><td colspan="2" scope="row"><content styleCode="bold">CHILDREN 6 TO UNDER 12 YEARS OF AGE</content></td></tr><tr><td colspan="2" scope="row"><list><item>the growth rate of some children may be slower while using this product. Talk to your child&#x2019;s doctor if your child needs to use the spray for longer than two months a year</item></list></td></tr><tr><td scope="row">children 6 to under 12 years of age</td><td><list><item>an adult should supervise use</item><item>once daily, spray 1 time into each nostril while sniffing gently</item><item>if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day</item></list></td></tr><tr><td scope="row">children under 6 years of age</td><td><list><item>do not use</item></list><paragraph/></td></tr><tr><td colspan="2" scope="row"><list><item><content styleCode="bold">do not use more than directed</content></item><item>if you forget a dose, do<content styleCode="bold"> not</content> double the next dose</item><item>do <content styleCode="bold">not</content> spray into eyes or mouth</item><item>if allergy symptoms do not improve after two weeks, stop using and talk to a doctor</item><item>do not use for the common cold</item><item>shake well before each use</item></list></td></tr></tbody></table>

spl unclassified section

Other information do not use if the safety seal labeled "sealed for your protection" is broken or missing. keep package and insert. They contain important information. store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light.

辅料 / Inactive ingredients

Inactive ingredients carboxymethyl cellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid (for pH adjustment), microcrystalline cellulose, polysorbate 80, potassium sorbate, purified water

questions

Questions or comments? call toll free 1-800-645-2158

package label principal display panel

Principal Display Panel - Carton 120ms CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray Rugby Laboratories NDC 0536-1112-48 Budesonide Nasal Spray Allergy Spray 120 sprays Relief of: Nasal Congestion Runny Nose Itchy Nose Sneezing Principal Display Panel - Bottle 120ms BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray Rugby Laboratories NDC 0536-1112-48 Budesonide Nasal Spray Allergy Spray 120 sprays

来源、版本与许可

资料类型
美国药品标签原文
版本
12 / 20260227
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