Advil Cold and Sinus Liqui-Gel

Name: Advil Cold and Sinus Liqui-Gel

What is Advil Cold and Sinus Liqui-Gel (ibuprofen and pseudoephedrine)?

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Ibuprofen and pseudoephedrine is a combination medicine used to treat stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.

Ibuprofen and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Advil Cold and Sinus Liqui-Gel (ibuprofen and pseudoephedrine)?

Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning, especially in older adults.

Do not use ibuprofen and pseudoephedrine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

How should I take Advil Cold and Sinus Liqui-Gel (ibuprofen and pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger amounts or for longer than recommended. An overdose of ibuprofen can damage your stomach or intestines.

Take this medicine with food or milk to lessen stomach upset.

Call your doctor if you have a fever lasting longer than 3 days, if you have new symptoms, or if your condition does not improve after taking this medication for 7 days.

If you need surgery, tell the surgeon ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include vomiting, stomach pain, diarrhea, ringing in your ears, severe drowsiness, agitation, sweating, coughing up blood, weak or shallow breathing, fainting, or seizure (convulsions).

Advil Cold and Sinus Liqui-Gel (ibuprofen and pseudoephedrine) side effects

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using this medicine and call your doctor at once if you have:

  • confusion, severe drowsiness, ringing in your ears, severe dizziness, feeling like you might pass out;

  • fast, pounding, or uneven heartbeat;

  • easy bruising or bleeding (nosebleeds, bleeding gums);

  • the first sign of any skin rash, no matter how mild;

  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • liver problems--upper stomach pain, vomiting, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • kidney problems--little or no urinating, painful or difficult urination, swelling or rapid weight gain, feeling tired or short of breath;

  • nerve problems--fever, headache, neck stiffness, chills, increased sensitivity to light, seizure (convulsions); or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • diarrhea, constipation;

  • headache, dizziness, drowsiness, weakness;

  • upset stomach, nausea, vomiting, loss of appetite;

  • feeling anxious or excited;

  • sleep problems (insomnia); or

  • flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For Healthcare Professionals

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 Cold and Sinus Liqui-Gels may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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