BOXED WARNING WARNING Hepatotoxicity Isometheptene, Caffeine, and Acetaminophen Tablets contain acetaminophen, isometheptene mucate and caffeine. Acetaminophen has been associated with cases of acute liver failure at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often in combination with other acetaminophen-containing products.
boxed warning table
<table frame="void" width="638"> <tbody> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top"> <content styleCode="bold">WARNING</content> <content styleCode="bold">Hepatotoxicity</content>Isometheptene, Caffeine, and Acetaminophen Tablets contain acetaminophen, isometheptene mucate and caffeine. Acetaminophen has been associated with cases of acute liver failure at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often in combination with other acetaminophen-containing products. </td> </tr> </tbody> </table>
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warnings
WARNINGS Hepatotoxicity - Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well. Hypersensitivity/Anaphylaxis – There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Isometheptene, Caffeine, and Acetaminophen Tablets immediately and seek medical care if they experience these symptoms. Do not prescribe Isometheptene, Caffeine, and Acetaminophen Tablets for patients with acetaminophen allergy.