Epidrin

Follow all directions on your prescription label. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

You may take this medication with or without food.

To treat migraine headache pain:

• Take the first dose of this medication as soon as you notice headache symptoms, or after an attack has already begun.

• If your headache does not completely go away, take 1 capsule every hour until you feel relief.

• Do not take more than a total of 5 capsules in any 12-hour period to treat a migraine.

• If you still have migraine symptoms after taking a total of 5 capsules, call your doctor.

To treat tension headache pain:

• Take the first dose of this medication as soon as you notice tension headache symptoms.

• If your headache does not completely go away, take 1 capsule every 4 hours until you feel relief.

• Do not take more than a total of 8 capsules in any 24-hour period to treat a tension headache.

• If you still have tension headache pain after taking a total of 8 capsules, call your doctor.

Call your doctor if this medication seems to stop working as well in relieving your pain. Also call your doctor if your headaches get worse or you have more than 2 headaches per week.

Do not stop using this medicine suddenly if you have been using it for longer than 2 weeks in a row, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop using acetaminophen, dichloralphenazone, and isometheptene.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using acetaminophen, dichloralphenazone, and isometheptene.

Store at room temperature away from moisture, heat, and light.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can damage your liver or cause death.

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.

Applies to acetaminophen / dichloralphenazone / isometheptene mucate: oral capsule

Hypersensitivity

Transient dizziness and skin rash can usually be eliminated by reducing the dose of acetaminophen/dichloralphenazone/isometheptene.[Ref]

Hypersensitivity side effects including transient dizziness and skin rash have been reported with the use of acetaminophen/dichloralphenazone/isometheptene. Hypersensitivity reactions, including anaphylaxis and fixed drug eruptions have been reported rarely in association with acetaminophen use.[Ref]

Hepatic

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. However, hepatotoxicity has been reported following 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.

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

Cases of acute pancreatitis have been reported rarely with the use of acetaminophen.[Ref]

Hepatic side effects including severe and sometimes fatal dose dependent hepatitis have been reported with the use of acetaminophen in alcoholic patients. Hepatotoxicity has been increased during fasting.[Ref]

Gastrointestinal

Gastrointestinal side effects have been rare with the use of acetaminophen except in alcoholics and after overdose.[Ref]

Renal

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

Acute tubular necrosis with acetaminophen use usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well.

A recent case-control study of patients with end-stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end-stage renal disease particularly in patients taking more than two pills per day.[Ref]

Hematologic

Hematologic side effects including rare cases of thrombocytopenia associated with acetaminophen have been reported. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.[Ref]

Dermatologic

Dermatologic side effects including erythematous skin rashes associated with acetaminophen have been reported rarely. Acetaminophen associated bullous erythema and purpura fulminans have also been reported.[Ref]

Respiratory

Respiratory side effects including a case of acetaminophen-induced eosinophilic pneumonia have been reported.[Ref]

Cardiovascular

Cardiovascular side effects including at least two cases of hypotension have been reported following the administration of acetaminophen.[Ref]

Two cases hypotension have been reported following the administration of acetaminophen. Both patients experienced significant decreases in blood pressure. One of the two patients required pressor agents to maintain adequate mean arterial pressures. Neither episode was associated with symptoms of anaphylaxis. Neither patient was rechallenged after resolution of the initial episode.[Ref]

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