FDA Label for Ibuprofen
View Indications, Usage & Precautions
Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Advanced First Aid, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)
*nonsteroidal anti-inflammatory drug
Otc - Purpose
pain reliever/fever reducer
Indications & Usage
Uses:
temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • toothache • menstrual cramps • common cold • 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 • skin reddening • blisters If an allergic reaction occurs, stop use and seek medical help right away.
Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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] • 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: • 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 heart burn • high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke • you are taking a diuretic
Ask a doctor or pharmacist before use if you are: • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • under a doctor’s care for any serious condition • taking any other drug
When using this product: • take with food or milk if stomach upset occurs
Stop use and ask a doctor if: • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • or if redness or swelling is present in the painful area • any new symptoms appear • You experience any of the following signs of stomach bleeding: • feel faint • vomit blood • or 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 the body • slurred speach •leg swelling
Otc - Pregnancy Or Breast Feeding
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.
Otc - 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.
Dosage & Administration
Directions:
Adults and children 12 years of age and older:
• do not take more than directed • the smallest effective dose should be used • 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 of age: ask a doctor
Inactive Ingredient
Inactive Ingredients: croscarmellose sodium*, FD& C Blue #2*, FD& C Red #40*, FD& C Yellow #6*, hypromellose*, iron oxide red*, lactose monohydrate*, magnesium stearate*, maltodextrin*, medium chain triglycerides*, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, polyvinyl alcohol*, Povidone (K-30)*, silicon dioxide, sodium starch glycolate*, starch, stearic acid*, talc*, titanium dioxide, triacetin*.
*contains one or mored of these ingredients
Package Label.Principal Display Panel
* Please review the disclaimer below.