说明与适用边界
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spl product data elements
Direct Safety Ibuprofen Ibuprofen SILICON DIOXIDE STARCH, CORN POLYETHYLENE GLYCOL, UNSPECIFIED FERRIC OXIDE RED TALC POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE IBUPROFEN IBUPROFEN POLYVINYL ALCOHOL, UNSPECIFIED REDDISH BROWN G;2
spl unclassified section
Drug Facts
Other information ■ read all product information before using ■ store at 68-77°F (20-25°C) ■ avoid excessive heat 40°C (above 104°F) ■ tamper evident sealed packets ■ do not use any opened or torn packets
活性成分 / Active ingredient
Active ingredient 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 associated with ■ headache ■ toothache ■ backache ■ menstrual cramps ■ common cold ■ muscular aches ■ minor arthritis pain 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 ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ 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 or 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.
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 ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ stomach bleeding warning applies to you ■ you have a history of stomach problems such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you have asthma ■ 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 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 ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ redness or swelling is present in the painful area ■ any new or unexpected symptoms occur
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 specifically 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 use more than directed ■ the smallest effective dose should be used ■ do not take longer than 10 days, unless directed by a doctor (see Warnings) Adults and children: (12 years and older) 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: Do not give to children under 12 years of age.
辅料 / Inactive ingredients
Inactive ingredients carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone K30*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide *may contain
questions
Questions or comments? 1-800-356-9100
package label principal display panel
Direct Dafety Ibuprofen Label Direct Safety® Ibuprofen Pain Reliever/Fever reducer Ibuprofen 200 mg. (NSAID) Ibuprofeno 200 mg. (AINE) This Package is for Households without Young Children. Este Paquete es Para Hogares Sin Ninos Pequenos Pull To Open Tire Para Abrir Industrial Pack 500 (250 Packets of 2 Tablets) DS Ibuprofen Label 20
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 9 / 20250909
- 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.

