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.

Infants' Advil® Concentrated Drops
Drug Facts
Active ingredient
(in each 1.25 mL)		 Purpose
Ibuprofen 50 mg (NSAID)* Fever reducer/Pain reliever
*nonsteroidal anti-inflammatory drug
Uses temporarily:
reduces fever relieves minor aches and pains due to the common cold, flu, headaches and toothaches
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 the child:
has had stomach ulcers or bleeding problems
takes a blood thinning (anticoagulant) or steroid drug
takes other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others]
takes more or for a longer time than directed
Do not use
if the child has 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 child has
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
not been drinking fluids
lost a lot of fluid due to vomiting or diarrhea
high blood pressure
heart or kidney disease
taken a diuretic
Ask a doctor or pharmacist before use if the child is
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 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
the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding stomach pain or upset gets worse or lasts the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
this product does not contain directions or complete warnings for adult use
do not give more than directed
do not give longer than 10 days, unless directed by a doctor (see Warnings)
shake well before using
find right dose on chart below. If possible, use weight to dose; otherwise use    age.
repeat dose every 6-8 hours, if needed
do not use more than 4 times a day
measure with the dosing device provided. Do not use with any other device.

Dosing Chart
Weight (lb) Age (mos) Dose (mL)
under 6 mos ask a doctor
12-17 lb 6-11 mos 1.25 mL
18-23 lb 12-23 mos 1.875 mL
Other information
one dose lasts 6-8 hours
store at 20-25°C (68-77°F)
see bottom of box for lot number and expiration date
Inactive ingredients (FRUIT FLAVOR)
artificial flavors, carboxymethylcellulose sodium, citric acid, edetate disodium, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
Inactive ingredients (GRAPE FLAVOR)
artificial flavor, carboxymethylcellulose sodium, citric acid, edetate disodium, FD&C blue no.1, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
Inactive ingredients (WHITE GRAPE FLAVOR)
artificial flavor, carboxymethylcellulose sodium, citric acid, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
Questions or comments? call toll-free 1-800-88-ADVIL or ask your phamacist, doctor or health care professional