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西药 · 美国药品标签原文

布洛芬 · 布洛芬 · Ibuprofen

IBUPROFEN

Ibuprofen · L.N.K. International, 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

Ibuprofen ibuprofen IBUPROFEN IBUPROFEN CARNAUBA WAX SILICON DIOXIDE STARCH, CORN FD&C YELLOW NO. 6 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED ANHYDROUS LACTOSE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE 44;392

活性成分 / Active ingredient

Active ingredient (in each orange tablet) Ibuprofen USP, 200 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: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever

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) skin reddening shock 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 are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take 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. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin 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 you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain weakness in one part or side of body trouble breathing slurred speech leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days any new symptoms appear redness or swelling is present in the painful area If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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 if you have ever had an allergic reaction to 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 you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin 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 you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain weakness in one part or side of body trouble breathing slurred speech leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days any new symptoms appear redness or swelling is present in the painful area

孕哺期 / Pregnancy or breastfeeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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 do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

储存 / Storage and handling

Other information store between 20°-25°C (68°-77°F) avoid excessive heat 40°C (104°F) use by expiration date on package

辅料 / Inactive ingredients

Inactive ingredients carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow #6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

questions

Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

package label principal display panel

Principal Display Panel Quality + Plus NDC 50844-392-16 † Compare to active ingredient in Motrin® IB IBUPROFEN TABLETS USP, 200 mg PAIN RELIEVER/FEVER REDUCER (NSAID) 1000 Coated Tablets ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING † This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Motrin® IB. 50844 REV1221C39216 Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive, Hauppauge, NY 11788 USA Quality Plus 44-392 Quality Plus 44-392

来源、版本与许可

资料类型
美国药品标签原文
版本
15 / 20260618
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