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® Flu & Body Ache
Drug Facts
Active ingredients (in each caplet) Purposes
Ibuprofen 200 mg (NSAID)* Pain reliever/Fever reducer
Pseudoephedrine HCl 30 mg Nasal decongestant
*nonsteroidal anti-inflammatory drug
Uses
temporarily relieves these symptoms associated with the common cold, or flu:
headachefeversinus pressurenasal congestionminor body aches and pains
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 if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
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
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
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 any other product that contains pseudoephedrine, or any other nasal decongestant taking aspirin for heart attack or stroke 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 nasal congestion lasts for more than 7 days symptoms continue or get worse stomach pain or upset gets worse or lasts redness or swelling is present in the painful area you get nervous, dizzy, or sleepless 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 of age and over:
take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not    respond to 1 caplet, 2 caplets may be used.
do not use more than 6 caplets in any 24-hour period unless directed by a    doctor
children under 12 years of age: consult a doctor
Other information
store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
read all warnings and directions before use. Keep carton.
Inactive ingredients
carnauba or equivalent wax, croscarmellose sodium, iron oxide, methylparaben, microcrystalline cellulose, propylparaben, silicon dioxide, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, sucrose, titanium dioxide
Questions or comments? call toll-free 1-800-88-ADVIL