说明与适用边界
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spl product data elements
Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 FERRIC OXIDE RED STEARIC ACID TITANIUM DIOXIDE FERRIC OXIDE YELLOW Light Brown to Brown N;II
活性成分 / Active ingredient
Drug Facts Active ingredient (in each tablet) Ibuprofen USP 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
用途 / Purpose
Purposes Pain reliever/Fever reducer
适应证 / Indications and usage
Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps 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.
禁用事项 / Do not use
Do not use if you have 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 you have problems or serious side effects from taking pain relievers or fever reducers the 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, 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 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 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. (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 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 ask a doctor
dosage and administration table
<table cellspacing="0" cellpadding="0" border="0" width="591"><colgroup><col width="44.6750902527076%"/><col width="55.3249097472924%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">adults and children 12 years and older </td><td styleCode="Rrule" valign="middle"><list listType="unordered" styleCode="disc"><item>take 1 tablet every 4 to 6 hours while symptoms persist</item><item>if pain or fever does not respond to 1 tablet, 2 tablets may be used</item><item>do not exceed 6 tablets in 24 hours, unless directed by a doctor</item></list></td></tr><tr><td styleCode="Lrule Rrule" valign="middle">children under 12 years </td><td styleCode="Rrule" valign="middle"><list listType="unordered" styleCode="disc"><item>ask a doctor</item></list></td></tr></tbody></table>
储存 / Storage and handling
Other information store between 20° to 25°C (68° to 77°F) do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing. see bottom panel for lot number and expiration date
辅料 / Inactive ingredients
Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, polyethylene glycol, red iron oxide, stearic acid, titanium dioxide and yellow iron oxide Questions or comments? Call 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/16/2014
package label principal display panel
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Bottle) AUROHEALTH NDC 58602-708-07 Ibuprofen Tablets USP 200 mg Pain Reliever/Fever Reducer (NSAID) 100 Coated Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablet Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Container Carton) AUROHEALTH NDC 58602-708-07 #Compare to the active ingredient of MOTRIN ® IB Ibuprofen Tablets USP 200 mg Pain Reliever/Fever Reducer (NSAID) 100 Coated Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Container Carton)
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 4 / 20241226
- 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.

