Advil Infants Concentrated Drops

• 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

• one dose lasts 6-8 hours
• store at 20-25°C (68-77°F)
• see bottom of box for lot number and expiration date

Infant’s Advil Concentrated Drops White Grape (dye-free)

acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Infant’s Advil Concentrated Drops Grape

acetic acid, artificial flavors, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Infants’ Advil Concentrated Drops

Ibuprofen, 50 mg Fever Reducer/Pain Reliever (NSAID) per 1.25 mL

Fever

Aches & Pains

Lasts up to 8 Hours

Dye-Free

White Grape Flavored Drops for ages 6-23 months

1/2 FL OZ (15 mL)

Alcohol Free

Important: Read all product information before using. Keep this box for important information. This product is intended for use in children ages 6 months - 23 months.

For most recent product information, visit www.Advil.com.

Rinse the oral syringe with tap water only

Wyeth

Wyeth Consumer Healthcare Madison, NJ 07940 USA © 2009 Wyeth

Do Not Use if breakable ring on bottle cap is separated or missing.

Child-Resistant Safety Cap

Applies to ibuprofen: oral capsule, oral capsule liquid filled, oral suspension, oral tablet, oral tablet chewable

Other dosage forms:

• intravenous solution

Along with its needed effects, ibuprofen (the active ingredient contained in Advil Infant's Concentrated Drops) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ibuprofen:

• Abdominal pain
• acid or sour stomach
• belching
• bloating
• cloudy urine
• decrease in amount of urine
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• difficulty having a bowel movement (stool)
• excess air or gas in stomach or intestines
• full feeling
• heartburn
• indigestion
• itching skin
• pain or discomfort in chest, upper stomach, or throat
• pale skin
• passing gas
• nausea
• noisy, rattling breathing
• rash with flat lesions or small raised lesions on the skin
• shortness of breath
• swelling of face, fingers, hands, feet, lower legs, or ankles
• troubled breathing at rest
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• weight gain

• Abdominal cramps
• stomach soreness or discomfort

• Agitation
• back, leg, or stomach pains
• bleeding gums
• blistering, peeling, loosening of skin
• blood in urine or stools
• bloody, black, or tarry stools
• blurred vision
• burning feeling in chest or stomach
• change in vision
• chest pain
• chills
• clay-colored stools
• coma
• confusion
• constipation
• cough or hoarseness
• dark urine
• decreased urine output
• depression
• difficulty breathing
• difficulty swallowing
• dilated neck veins
• dizziness
• dry mouth
• extreme fatigue
• fast, irregular, pounding, or racing heartbeat or pulse
• fever with or without chills
• frequent urination
• general body swelling
• general feeling of tiredness or weakness
• hair loss, thinning of hair
• headache
• hives or welts
• hostility
• impaired vision
• increased blood pressure
• increased volume of pale, dilute urine
• irregular breathing
• irritability
• itching
• joint or muscle pain
• lab results that show problems with liver
• lethargy
• light-colored stools
• loss of appetite
• lower back or side pain
• muscle twitching
• nosebleeds
• painful or difficult urination
• pains in stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of skin
• seizures
• severe abdominal pain, cramping, burning
• severe and continuing nausea
• sore throat
• sores, ulcers, or white spots in mouth or on lips
• stiff neck or back
• stomach upset
• stupor
• swollen or painful glands
• tenderness in stomach area
• thirst
• tightness in chest
• unpleasant breath odor
• upper right abdominal pain
• vomiting of blood
• vomiting of material that looks like coffee grounds
• wheezing
• yellow eyes and skin

• Bluish lips or skin
• difficulty sleeping
• disorientation
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• drowsiness to profound coma
• hallucination
• lightheadedness or fainting
• mood or other mental changes
• muscle tremors
• not breathing
• rapid, deep breathing
• restlessness
• slow or irregular heartbeat
• stomach cramps
• sudden fainting
• sweating

Some side effects of ibuprofen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Continuing ringing or buzzing or other unexplained noise in ears
• hearing loss
• nervousness

• Crying
• depersonalization
• discouragement
• dry eyes
• dysphoria
• euphoria
• feeling sad or empty
• lack of appetite
• loss of interest or pleasure
• mental depression
• paranoia
• quick to react or overreact
• rapidly changing moods
• runny nose
• sleepiness or unusual drowsiness
• sleeplessness
• sneezing
• stuffy nose
• trouble concentrating
• trouble sleeping
• unable to sleep