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spl product data elements
Ibuprofen Ibuprofen SILICON DIOXIDE FERRIC OXIDE RED POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE K30 STARCH, PREGELATINIZED CORN SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN G2
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredient (in each tablet) Ibuprofen 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) 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: 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 under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if ■ side effects occur. You may report side effects to FDA at 1-800-FDA-1088. ■ 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 ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present in the painful area ■ any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of 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 (1-800-222-1222).
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
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 ■ side effects occur. You may report side effects to FDA at 1-800-FDA-1088. ■ 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 ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present in the painful area ■ any new symptoms appear
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 during the last 3 months of 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 (1-800-222-1222).
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 at 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F) read all warnings and directions before use retain carton for complete product information and warnings
辅料 / Inactive ingredients
Inactive ingredients colloidal silicon dioxide, corn starch, iron oxide red, polyethylene glycol, polyvinyl alcohol, povidone K30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
questions
Questions or comments? 1-844-292-1112
package label principal display panel
PRINCIPAL DISPLAY PANEL Akways Save® IBUPROFEN TABLETS, 200 mg PAIN RELIEVER/FEVER REDUCER (NSAID) ACTUAL SIZE 500 COATED TABLETS image description
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 4 / 20251211
- 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.

