Ibuprofen Tablet, Coated
FDA Label NDC 41226-601

Ibuprofen 200 mg (NSAID)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain reliever/Fever reducer

Uses
•temporarily relieves minor aches and pains due to:
backache
headache
menstrual cramps
minor pain of arthritis
muscular aches
the common cold
toothache
•temporarily reduces fever

Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
•asthma (wheezing)
•blisters
•facial swelling
•hives
•rash
•shock
•skin reddening.
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 ibuprofen or any other pain reliever/fever reducer
•right before or after heart surgery

Ask a doctor before use if
•you have problems or serious side effects from taking pain relievers or fever reducers
•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

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
•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 problem or stroke:
chest pain
trouble breathing
weakness in one part or side of the body
slurred speech
leg swelling
•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 (1-800-222-1222).

Directions
•do not take 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 exceed 6 tablets in 24 hours, unless directed by a doctor

children under 12 years:
•ask a doctor

Other information

• read all warnings and directions before use
• store at 20-25°C (68-77°F)

Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc,titanium dioxide.

Call 1-800-632-6900