Advil. The Pain Reliever for Fast, Strong Pain Relief.

This is the most current labeling information, and may differ from labels on product packaging. If there are any differences between this website labeling and product package labeling, this website labeling should be regarded as the most current.

The FDA has approved enhanced warning labels for all over the counter non-steroidal anti-inflammatory drug analgesics (NSAID), including all Advil® products. These new labels will provide consumers with more information about potential cardiovascular, gastrointestinal and allergic risks.

Products with revised labels should be in stores by late 2006. In the meantime, we have posted the revised label on this Web site. We continue to work with the FDA to ensure the effective labeling of our products.

Wyeth Consumer Healthcare stands firmly behind the safety and effectiveness of Advil®. However, we encourage all consumers to read the new, enhanced Advil® labeling, with special attention to the Warnings. All drugs, including those without a prescription, must be used according to their directions to be safe and effective.

Advil® Tablets
Drug Facts
Active ingredient (in each tablet) Purposes
Ibuprofen 200 mg (NSAID)* Pain reliever/Fever reducer
*nonsteroidal anti-inflammatory drug
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:
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 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 an NSAID [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
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 you have
problems or serious side effects from taking pain relievers or fever reducers stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ulcers bleeding problems high blood pressure heart or kidney disease taken a diuretic reached age 60 or older
Ask a doctor or pharmacist before use if you are
taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) or steroid drug 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 long term continuous use may increase the risk of heart attack or stroke
Stop use and ask a doctor if
you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts 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.
Directions
do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings) 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. Keep carton. store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
Inactive ingredients
acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax
Questions or comments? call toll-free 1-800-88-ADVIL