Ornex Maximum Strength

Ask a doctor before taking medicine that contains acetaminophen if you have ever had liver disease, or if you drink more than 3 alcoholic beverages per day.

You should not use this medicine if you are allergic to acetaminophen (Tylenol) or pseudoephedrine, or if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid.

Do not use cough or cold medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Ask a doctor or pharmacist if it is safe for you to take acetaminophen and pseudoephedrine if you have:

• liver disease, cirrhosis, or a history of alcoholism;

• diabetes;

• epilepsy or other seizure disorder;

• pheochromocytoma (an adrenal gland tumor); or

• enlarged prostate or urination problems.

It is not known whether acetaminophen and pseudoephedrine will harm an unborn baby. Do not use cough or cold medicine without a doctor's advice if you are pregnant.

Acetaminophen and pseudoephedrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use cough or cold medicine without a doctor's advice if you are pregnant.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

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

• fast, slow, or uneven heart rate;

• confusion, hallucinations;

• tremor, seizure (convulsions);

• little or no urinating;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, seizure).

Common side effects may include:

• dizziness, weakness;

• mild headache;

• mild nausea, diarrhea, upset stomach;

• runny nose;

• feeling nervous, restless, or anxious; or

• sleep problems (insomnia).

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.

Other drugs may interact with acetaminophen and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Not able to pass urine or change in how much urine is passed.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Applies to acetaminophen / pseudoephedrine: oral capsule, oral liquid, oral tablet, oral tablet chewable

Cardiovascular

Cardiovascular adverse effects of pseudoephedrine have included significant rises in heart rate. Hypertension and arrhythmias have been problematic in susceptible patients.[Ref]

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

Nervous system side effects of pseudoephedrine have included nervous system stimulation, resulting in tremor, anxiety, and nervousness. Insomnia has been reported in up to 30% of pseudoephedrine-treated patients. Headache has also occurred in patients receiving pseudoephedrine.[Ref]

Hepatic

Hepatic side effects of acetaminophen have been rare, except in alcoholics and after overdose. In these settings, severe and sometimes fatal (3% to 4%) dose-dependent hepatitis has been reported. Several cases of hepatotoxicity from chronic acetaminophen therapy at therapeutic doses have also been reported despite a lack of risk factors for toxicity[Ref]

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person, although hepatotoxicity has been reported with smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

A 19-year-old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.[Ref]

Gastrointestinal

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism for this side effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of oddi.[Ref]

Gastrointestinal side effects of acetaminophen are rare, except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely with acetaminophen use.

Gastrointestinal side effects of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat has occurred in up to 15% of patients.[Ref]

Renal

Renal side effects of acetaminophen have been rare and included acute tubular necrosis and interstitial nephritis. Adverse renal effects were most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.[Ref]

Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases.[Ref]

Hematologic

Hematologic side effects have included rare cases of thrombocytopenia associated with acetaminophen. Acute thrombocytopenia has also been reported as having been caused by sensitivity to acetaminophen glucuronide, the major metabolite of acetaminophen. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.[Ref]

Hypersensitivity

Hypersensitivity reactions to pseudoephedrine have included fixed drug eruptions.[Ref]

Dermatologic

Dermatologic side effects have included rare reports of general erythematous skin rashes associated with acetaminophen. A rare case of bullous erythema associated with acetaminophen has been reported. Acetaminophen has been associated with a risk of rare but potentially fatal serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).[Ref]

Metabolic

Metabolic side effects including metabolic acidosis have been reported following a massive overdose of acetaminophen.

In the case of metabolic acidosis, causality is uncertain as more than one drug was ingested. The case of metabolic acidosis followed the ingestion of 75 grams of acetaminophen, 1.95 grams of aspirin, and a small amount of a liquid household cleaner. The patient also had a history of seizures which the authors reported may have contributed to an increased lactate level indicative of metabolic acidosis.

Some side effects of Ornex Maximum Strength may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.