FDA Label for Ibuprofen

Active Ingredient (In Each Brown Tablet)

Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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

Warnings

Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• shock
• hives
• facial swelling
• asthma (wheezing)
• 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

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 - leg swelling
  - slurred speech - weakness in one part or side of body
• pain gets worse or lasts more than 10 days
• redness or swelling is present in the painful area
• fever gets worse or lasts more than 3 days
• any new symptoms occur

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.

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 (1-800-222-1222) right away.

Directions

• do not use more than directed
• the smallest effective dose should be used
• adults and children 12 years and over: 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 take more than 6 tablets in 24 hours unless directed by a doctor
• children under 12 years: ask a doctor

Other Information

• store between 20°-25°C (68°-77°F)
• avoid excessive heat 40°C (104°F)

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, cellulose, corn starch, hypromellose, lactose, magnesium stearate, polydextrose, PEG, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide.

Questions Or Comments?

Call 1-800-540-3765

How Supplied

Product: 50090-5021

NDC: 50090-5021-0 50 TABLET, FILM COATED in a BOTTLE

NDC: 50090-5021-3 24 TABLET, FILM COATED in a BOTTLE

NDC: 50090-5021-8 100 TABLET, FILM COATED in a BOTTLE