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西药 · 美国药品标签原文

布洛芬 · 布洛芬 · Childrens Ibuprofen Oral Suspension Dye Free

IBUPROFEN

Childrens Ibuprofen Oral Suspension Dye Free · FSA Store Inc. (Caring Mill)。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

Childrens Ibuprofen Oral Suspension Dye Free IBUPROFEN IBUPROFEN IBUPROFEN ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE XANTHAN GUM ORIGINAL BERRY

活性成分 / Active ingredient

Drug Facts Active ingredient (in each 5 mL) Ibuprofen, USP 100 mg (NSAID)** **nonsteroidal anti-inflammatory drug

用途 / Purpose

Purpose Pain reliever/fever reducer

适应证 / Indications and usage

Uses temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever

警告 / Warnings

Warnings Allergy alert : Ibuprofen may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters. If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child : has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drug containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed Heart attack and stroke warning : NSAIDs except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Sore throat warning : Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor. Do not use if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stool has stomach pain that does not get better child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear 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 if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery

咨询医生 / Ask a doctor

Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke child has asthma child is taking a diuretic

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug

使用中 / When using

When using this product take with food or milk if stomach upset occurs

停用事项 / Stop use

Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stool has stomach pain that does not get better child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear

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 this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL = milliliter find right dose on chart. if possible, use weight to dose; otherwise use age. use only enclosed dosing cup. Do not use any other dosing device. if needed, repeat dose every 6-8 hours do not use more than 4 times a day replace original bottle cap to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL *or as directed by a doctor

dosage and administration table

<table width="350px"><caption>Dosing Chart </caption><colgroup><col/><col/><col/></colgroup><tbody><tr><td><content styleCode="bold">Weight (lb)</content></td><td><content styleCode="bold">Age (yr)</content></td><td><content styleCode="bold">Dose (mL)*</content></td></tr><tr><td>under 24</td><td>under 2 years</td><td>ask a doctor</td></tr><tr><td>24-35 lbs</td><td>2-3 years</td><td>5 mL</td></tr><tr><td>36-47 lbs</td><td>4-5 years</td><td>7.5 mL</td></tr><tr><td>48-59 lbs</td><td>6-8 years</td><td>10 mL</td></tr><tr><td>60-71 lbs</td><td>9-10 years</td><td>12.5 mL</td></tr><tr><td>72-95 lbs</td><td>11 years</td><td>15 mL</td></tr></tbody></table>

其他安全资料 / Other safety information

Other information each 5 mL contains: Sodium 2 mg store between 20º to 25ºC (68º to 77ºF) ​do not use if printed neckband is broken or missing

辅料 / Inactive ingredients

Inactive ingredients Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum

questions

Questions or comments? Call 1 - 888-588-1418 from 9 AM to 5 PM ET, Monday-Friday.

package label principal display panel

Principal display panel list NDC 81522-311-11 †Compare to the active ingredient in Children's Motrin ® FOR AGES 2-11 YEARS CHILDREN'S IBUPROFEN 100 mg per 5 mL Oral Suspension, USP (NSAID) PAIN RELIEVER/FEVER REDUCER ORIGINAL Berry Flavor Dye-Free Alcohol-Free Lasts up to 8 HOURS 4 FL OZ (118mL) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children . †This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Motrin®. Manufactured for FSA Store Inc. 5473 Blair Rd Suite 100 PMB 24308 Dallas, TX 75231 res Untitled berry inner package

来源、版本与许可

资料类型
美国药品标签原文
版本
1 / 20250918
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