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spl product data elements
Ibuwin Forte Ibuprofen STARCH, CORN POVIDONE K30 STEARIC ACID SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE FERRIC OXIDE RED IBUPROFEN IBUPROFEN HYPROMELLOSE, UNSPECIFIED TRIACETIN LACTOSE MONOHYDRATE Reddish Brown G;2
spl unclassified section
Drug Facts
OTHER INFORMATION store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F) read all product information before using TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL IS BROKEN OR MISSING
活性成分 / Active ingredient
ACTIVE INGREDIENT (in each tablet/caplet) 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 the 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 or asthma 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 the risk of heart attack may increase if you use more than directed or for longer than directed STOP USE AND ASK A DOCTOR IF you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better 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.
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 the 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 or 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 the risk of heart attack may increase if you use more than directed or for longer than directed
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 have bloody or black stools vomit blood have stomach pain that does not get better 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.
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 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor
dosage and administration table
<table border="1" frame="void" width="589"><tbody><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top">adults and children 12 years and older</td><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><list listType="unordered" styleCode="Disc"><item>take 1 caplet every 4 to 6 hours while symptoms persist</item><item>if pain or fever does not respond to 1 caplet, 2 caplets may be used</item><item>do not exceed 6 caplets in 24 hours, unless directed by a doctor</item></list></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top">children under 12 years</td><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><list listType="unordered" styleCode="Disc"><item>ask a doctor</item></list></td></tr></tbody></table>
辅料 / Inactive ingredients
INACTIVE INGREDIENTS colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, lactose monohydrate, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide, triacetin
questions
QUESTIONS OR COMMENTS? Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us
package label principal display panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 69729-157-10 Ibuwin Forte Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) Analgésico/Antipirético (AINE) 10 Tablets/Tabletas BOX ESP
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20260715
- 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.

