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.

CHILDREN'S ADVIL® COLD SUSPENSION
Important: Read all product information before using. Keep this box
for important information. This product is intended for use in children
ages 2 years – 11 years. Drug Facts
Active ingredients (in each 5 mL teaspoon) Purposes
Ibuprofen 100 mg (NSAID)* Fever reducer/Pain reliever
*nonsteroidal anti-inflammatory drug
Pseudoephedrine HCl 15 mg Nasal decongestant
Uses temporarily relieves these cold, sinus and flu symptoms:
nasal and sinus congestion headache
stuffy nose sore throat
minor aches and pains 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 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
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.
Do not use
in a child under 2 years of age if the child has ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
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
thyroid disease
diabetes
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 product that contains pseudoephedrine or any other nasal decongestant 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 symptoms continue or get worse fever or pain or nasal congestion gets worse or lasts more than 3 days redness or swelling is present in the painful area the child gets nervous, dizzy, or sleepless or sleepy 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. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 6 hours do not use more than 4 times a day replace original bottle cap to maintain child resistance measure only with dosing cup provided. Dosing cup to be used with Children's Advil Cold Suspension only. Do not use with other products. Dose lines account for product remaining in cup due to thickness of suspension.

Weight (lb) Age (yrs) Dose (teaspoons)
under 24 under 2 yrs do not use
24 - 47 2 - 5 yrs 1 teaspoon
48 - 95 6 - 11 yrs 2 teaspoons
Other information
each teaspoon contains: sodium 3 mg
store at room temperature 20-25°C (68-77°F)
alcohol free
read all warnings and directions before use. Keep carton.
Inactive ingredients
artificial flavor, carboxymethylcellulose sodium, citric acid monohydrate, 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
Questions or comments? Call weekdays from 9am to 5pm EST at 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional