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.
Drug Facts:
Active ingredient (in each brown oval capsule) Purpose
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt) Pain reliever
*nonsteroidal anti-inflammatory drug
Uses:
Treats migraine.
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:
never had migraines diagnosed by a health professional a headache that is different from your usual migraines the worst headache of your life fever and stiff neck headaches beginning after or caused by head injury, exertion, coughing or bending experienced your first headache after the age of 50 daily headaches a migraine so severe as to require bed rest 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. migraine headache pain is not relieved or gets worse after first dose stomach pain or upset gets worse or lasts any new symptoms appear
If pregnant or breastfeeding, 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 an 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
Adults:
Take 2 capsules with a glass of water, if symptoms persist or worsen, ask your doctor, do not take more than 2 capsules in 24 hours, unless directed by a doctor
Under 18 years of age ask a doctor
Other information:
Each capsule contains: potassium 20 mg of, read all directions and warnings before use. Keep carton store at 20-25C (68-77?F) avoid excessive heat above 40C (104F)
Inactive ingredients:
DC yellow no. 10, FDC green no. 3, FDC red no. 40, gelatin, light mineral oil, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitans, sorbitol
