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西药 · 美国药品标签原文

布洛芬 · 布洛芬 · Concentrated ibuprofen infants

IBUPROFEN

Concentrated ibuprofen infants · Wal-Mart Stores, Inc.。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

Concentrated ibuprofen infants Ibuprofen IBUPROFEN IBUPROFEN ANHYDROUS CITRIC ACID GLYCERIN POLYSORBATE 80 STARCH, CORN WATER SODIUM BENZOATE SUCROSE XANTHAN GUM SORBITOL Mixed Berry

活性成分 / Active ingredient

ACTIVE INGREDIENT (in each 1.25 mL) Ibuprofen 50 mg (NSAID)* *nonsteroidal anti-inflammatory drug

用途 / Purpose

PURPOSE Pain reliever/fever reducer

适应证 / Indications and usage

USE(S) temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

警告 / Warnings

WARNINGS Allergy alert: Ibuprofen may cause a 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 you child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs 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 doctor.

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 DOCTOR IF child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools 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 the 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 find right dose on chart below. If possible, use weight to dose; otherwise use age. mL=milliliter measure with dosing device provided. Do not use any other dosing device. dispense liquid slowly into the child's mouth, toward the inner cheek if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart WEIGHT (lb) AGE (mos) DOSE (mL) under 6 mos ask a doctor 12-17 lbs 6-11 mos 1.25 mL 18-23 lbs 12-23 years 1.875 mL

dosage and administration table

<table cellspacing="0" cellpadding="0" border="0"><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"><content styleCode="bold">WEIGHT (lb) </content></td><td styleCode="Rrule" valign="middle"><content styleCode="bold">AGE (mos) </content></td><td styleCode="Rrule" valign="middle"><content styleCode="bold">DOSE (mL)</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="2" valign="middle"> under 6 mos </td><td styleCode="Rrule" valign="middle"> ask a doctor</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">12-17 lbs</td><td styleCode="Rrule" valign="middle"> 6-11 mos</td><td styleCode="Rrule" valign="middle"> 1.25 mL</td></tr><tr><td styleCode="Lrule Rrule" valign="middle"> 18-23 lbs</td><td styleCode="Rrule" valign="middle"> 12-23 years</td><td styleCode="Rrule" valign="middle"> 1.875 mL</td></tr></tbody></table>

储存 / Storage and handling

OTHER INFORMATION store between 20-25 o C (68-77 o F) do not use if carton is opened or if printed neckband is imprinted with "SEALED FOR YOUR PROTECTION" and "USE WITH ENCLOSED DOSING DEVICE ONLY" is broken or missing.

辅料 / Inactive ingredients

INACTIVE INGREDIENTS anhydrous citric acid, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

spl unclassified section

QUESTIONS OR COMMENTS? call 1-888-287-1915

package label principal display panel

PRINCIPAL DISPLAY PANEL See New Warnings NDC 49035-635-09 equate™ Compare to Concentrated Motrin ® Infants' Drops active ingredient* infants* Dye-Free Concentrated Infants' Drops IBUPROFEN Oral Suspension 50 mg per 1.25 mL For Ages 6 Mos. to 23 Mos. Pain Reliever/Fever Reducer (NSAID) Lasts up to 8 Hours Berry Flavor 1 fl oz (30 mL) 125

来源、版本与许可

资料类型
美国药品标签原文
版本
3 / 20220111
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