Ibuprofen

Generic: IBUPROFEN

Over-the-Counter DrugORAL

Drug Information

Brand Name
Ibuprofen
Generic Name
IBUPROFEN
Manufacturer
PLD Acquisitions LLC DBA Avma Pharma Solutions
Product Type
Over-the-Counter Drug
Route
ORAL
Application Number
1662a495-4f6a-4515-a405-557681e1a496

Pharmacological Class

Nonsteroidal Anti-inflammatory Drug [EPC]

Active Ingredients

Indications & 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

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 rash blisters skin reddening If an allergic reaction occurs, stop use an seek medical help right away. Stomach bleeding warning: This product contains an NSAID which may cause sever stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (a...

Read full 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 rash blisters skin reddening If an allergic reaction occurs, stop use an seek medical help right away. Stomach bleeding warning: This product contains an NSAID which may cause sever 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 non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) take more or for a longer time than directed have 3 or more alcoholic drinks every day while using this product 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, or kidney disease you have 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 or stroke 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 last more than 10 days fever gets worse or last more than 3 days redness or swelling is present 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).

Adverse Reactions

No specific warnings reported by FDA for this product.

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.

Ibuprofen - Side Effects, Warnings, Uses | FDA Drug Database