说明与适用边界
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spl product data elements
Ibuprofen Ibuprofen FD&C BLUE NO. 2 MAGNESIUM STEARATE LECITHIN, SOYBEAN CROSCARMELLOSE SODIUM POLYETHYLENE GLYCOL 4000 FD&C YELLOW NO. 5 POLYVINYL ALCOHOL, UNSPECIFIED MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE STARCH, CORN TALC FD&C YELLOW NO. 6 IBUPROFEN IBUPROFEN FERRIC OXIDE RED TITANIUM DIOXIDE BI06
活性成分 / Active ingredient
Active Ingredient (in each tablet) Ibuprofen, 200mg (NSAID*) *nonsteroidal anti-inflammatory drug
用途 / Purpose
Purpose Pain Releiver / Fever Reducer nonsteroidal anti-inflammatory drug
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
适应证 / Indications and usage
Uses Temporarily relieves minor aches and pains due to Common cold headache minor pain of arthritis toothache backache muscular aches menstrual cramps temporarily reduces fever
警告 / Warnings
Warnings Allergy alert Ibuprofen may cause severe allergic reactions, 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 a NSAID, which may cause severe stomach bleeding. The chances are higher if you: are age 60 or older have stomach ulcers or bleeding problems take 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. Contains FD+C Yellow No. 5 (tartrazine) as a color additive
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
儿童安全 / Keep out of reach of children
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 4-6 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 of age Ask a doctor
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 lsats 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.
spl unclassified section
Other Information Store at 20ºC - 25ºC (68ºF - 77ºF) Do not use if printed packet is torn or punctured. TAMPER EVIDENT child resistant packets. Do not use any opened or torn packets.
Distributed By: Distributed By: Trifecta Pharmaceuticals USA® Ft. Lauderdale, FL. 33301 USA 1-888-296-9067 *This product is not manufactured or distributed by Pfizer, owner of the registered trademark Advil® Reorder No. 2022 Made in the USA
辅料 / Inactive ingredients
Inactive Ingredients Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C Blue #2, FD&C Yellow #5, FD&C Yellow #6, Iron Oxide Red, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized Starch, Talc, Titanium Dioxide
questions
Questions or Comments? Call 1-888-296-9067 IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP BOX FOR COMPLETE WARNINGS AND INFORMATION.
使用中 / When using
When using this product Take with food or milk if stomach upset occurs
package label principal display panel
globe ibuprofin 200mg 50pk child resistant CDER
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20241231
- 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.

