Advil Childrens Cold

temporarily relieves these cold, sinus and flu symptoms:

• nasal and sinus congestion
• headache
• stuffy nose
• sore throat
• minor aches and pains
• fever

• 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.

Call weekdays from 9 AM to 5 PM EST at 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Belly pain or heartburn.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to ibuprofen / pseudoephedrine: oral capsule, oral suspension, oral tablet

Gastrointestinal

Gastrointestinal side effects of ibuprofen may occur in up to 25% of patients, are usually mild and transient, and include dyspepsia, nausea, diarrhea, abdominal pain, and flatulence. More serious gastrointestinal effects of ibuprofen are uncommon but include occult blood loss, ulcer, gastrointestinal hemorrhage with or without perforation, and pancreatitis. In addition, a case of ibuprofen-associated colitis has been reported.

Pseudoephedrine may also cause gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat may occur in up to 15% of patients.[Ref]

The incidence of gastrointestinal blood loss with ibuprofen is dose-related, occurring in up to 17% of patients receiving 1,600 mg per day and in 23% of patients receiving 2,400 mg per day.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effect. Ibuprofen should be used with caution in these patients.[Ref]

Renal

Renal side effects including new or worsened renal insufficiency has commonly been associated with the use of nonsteroidal anti-inflammatory drugs. Patients at higher risk of developing renal insufficiency during therapy include the elderly, patients with preexisting renal insufficiency, and any patients with a history of heart failure or renal artery stenosis. Rarer renal side effects associated with the use of ibuprofen include the nephrotic syndrome with and without renal failure and acute renal failure due to tubulointerstitial nephritis, papillary necrosis, and acute tubular necrosis.[Ref]

Ibuprofen may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for ibuprofen-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-controlled study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.[Ref]

Cardiovascular

Cardiovascular side effects of ibuprofen include peripheral edema (1% to 3%) and elevated blood pressure (less than 1%). These problems may be important in some patients with preexisting hypertension or congestive heart failure.

Cardiovascular adverse effects associated with pseudoephedrine may include a significant rise in heart rate. Hypertension and arrhythmias may be problematic in susceptible patients.[Ref]

A rare case of painful, persistent peripheral cyanosis and swelling of the fingers and toes which progressed to desquamation and digital pitting infarctions has been associated with ibuprofen.

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.[Ref]

Nervous system

The incidence of aseptic meningitis associated with ibuprofen is higher in patients with systemic lupus erythematosus and other connective tissue disease, although it has been reported in patients without such underlying disease states.[Ref]

Central nervous system side effects of ibuprofen are rare and have included headache, drowsiness, and dizziness. Aseptic meningitis, paresthesias, and pseudotumor cerebri have rarely been associated with the use of ibuprofen.

Pseudoephedrine produces nervous system stimulation, resulting in tremor, anxiety, and nervousness. Headache or insomnia has been reported in up to 30% of patients.[Ref]

Hepatic

Elevations in liver function tests three times normal values occur in less than 1% of patients treated with ibuprofen. Ibuprofen-induced hepatitis has been associated with a fatal outcome in some cases.[Ref]

Hepatic side effects have included elevations in liver function tests in up to 15% of patients. Rarely, jaundice, cholestasis, hepatitis, and hepatic failure have been reported. Ibuprofen has also been implicated in the so-called acute vanishing bile duct syndrome in children and in cases of acute hepatitis in patients with established stable, chronic hepatitis C infection.[Ref]

Metabolic

Metabolic side effects of ibuprofen include hyponatremia and the Syndrome of Inappropriate Antidiuretic Hormone (SIADH), gynecomastia, hypoglycemia, and metabolic acidosis.[Ref]

Hypersensitivity

Hypersensitivity reactions to ibuprofen include erythematous or urticarial rashes, pruritus, angioedema, bronchospasm, and anaphylactoid reactions. Patients who are at higher risk of hypersensitivity reactions to ibuprofen include those with the syndrome of asthma, nasal polyps, and angioedema and/or bronchospastic reactivity to aspirin. Rare cases of systemic reactions, including interstitial nephritis and diffuse pulmonary infiltrates, have also been reported.

Hypersensitivity reactions to pseudoephedrine may also occur. Fixed drug eruptions secondary to pseudoephedrine have been reported.[Ref]

Hematologic

Hematologic side effects of ibuprofen include platelet dysfunction, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, eosinophilia, and decreases in hemoglobin and hematocrit.[Ref]

Reductions in serum hemoglobin concentrations are uncommon and are usually associated with occult gastrointestinal blood loss. Rare cases of ibuprofen-associated hemolytic anemia, autoimmune thrombocytopenia, and leukopenia have been reported.[Ref]

Respiratory

Respiratory side effects including noncardiogenic pulmonary edema have been associated with the use of ibuprofen.[Ref]

Acute noncardiogenic pulmonary edema developed on two occasions in an HIV-positive patient. Infectious as well as cardiac etiologies were excluded. A close temporal relationship with the administration of ibuprofen and onset of symptoms was noted.[Ref]

Dermatologic

Dermatologic reactions associated with the use of ibuprofen are uncommon but include maculopapular rash, pruritus, vesiculobullous eruptions, erythema multiforme, Stevens-Johnson syndrome, alopecia, toxic epidermal necrolysis, and photosensitivity reactions.[Ref]

Other

Other side effects associated with the use of ibuprofen include tinnitus (1% to 3%), vertigo, blurred vision (less than 1%), scotomata, and diplopia.[Ref]

Some side effects of Advil Children's Cold may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Data not available

The FDA has not approved use of over-the-counter cough and cold medications to children aged less than 2 years, and proper dosing for children in this age group has not been studied. Clinicians should be aware of the risk for serious illness or fatal overdose from administration of cough and cold medications to children aged less than 2 years. Clinicians should be certain that caregivers understand 1) the importance of administering cough and cold medications only as directed and 2) the risk for overdose if they administer additional medications that might contain the same ingredient.

Patients should be advised that when using this product the risk of heart attack or stroke may increase if they use more than directed or for longer than directed.

Ibuprofen-pseudoephedrine has not been formally assigned to a pregnancy category by the FDA. Animal studies failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. While there are no literature reports linking the use of ibuprofen in pregnancy with birth defects, use late in pregnancy may cause premature closure of the ductus arteriosus and prolong labor and delivery. Ibuprofen should be avoided near term. Based on available data, pseudoephedrine is not thought to be teratogenic. Ibuprofen-pseudoephedrine is only recommended for use during pregnancy when benefit outweighs risk.

One manufacturer of ibuprofen has reported 50 in utero exposures to ibuprofen. Seven cases were reported retrospectively and included one-third trimester fetal death of unknown cause, one spontaneous abortion without evidence of abnormalities, anencephaly (N=1), petit mal seizures progressing to grand mal seizures (N=1), cerebral palsy (N=1), microphthalmia, nasal cleft, and mildly rotated palate (N=1), and tooth staining (N=1). Of the 43 prospective cases, 23 were followed to a normal delivery. Of the remaining cases, one ended in a stillbirth without abnormalities, one ended in a spontaneous abortion without abnormalities, and the remaining were lost to follow-up. A case controlled surveillance study reported an elevated relative risk (3.2) of gastroschisis with first-trimester pseudoephedrine use in 76 cases. Relative risk for other drugs was 1.6 for salicylates, 1.7 for acetaminophen, 1.3 for ibuprofen, and 1.5 for phenylpropanolamine (not significant). The authors hypothesized vascular disruption was the etiology of gastroschisis. A second group of 416 infants with heterogenous defects suspected to have a vascular etiology was reviewed. There was no increased risk associated with salicylates, ibuprofen, pseudoephedrine, phenylpropanolamine, or other decongestants. These data require independent confirmation. In a review of 229,101 deliveries to Michigan Medicaid patients, 940 first-trimester exposures to pseudoephedrine and 1919 exposures anytime during pregnancy were recorded. A total of 37 birth defects were reported with first trimester exposure (40 expected) and included (observed/expected) 3/9 cardiovascular defects, 2 oral clefts, and 3/2 polydactyly. These researchers reviewed nine cases of abdominal wall defects in the 1980-1983 Medicaid data compared to 3752 pseudoephedrine exposed pregnancies. Seven of the nine cases had been exposed to pseudoephedrine providing a relative risk of 1.8. Only one case was a surgically treated abdominal wall defect. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) The Collaborative Perinatal Project monitored 50,282 mother-child pairs. Only 39 first-trimester exposures to pseudoephedrine were recorded, with one birth defect observed. For use anytime during pregnancy, 194 exposures were recorded with 3 birth defects observed (3.22 expected). The effect of pseudoephedrine on uterine and fetal blood flow was studied in 12 healthy pregnant women between 26 and 40 weeks gestation. Following a single 60 mg dose of pseudoephedrine, no significant effect was seen on fetal heart rate, uterine blood flow, or fetal aortic blood flow.