Isometheptene, Caffeine, and Acetaminophen Tablets

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 selfharm 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.

Serious Skin Reactions - Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of severe skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

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 Mucate, Caffeine, and Acetaminophen Caplets immediately and seek medical care if they experience these symptoms. Do not prescribe Isometheptene Mucate, Caffeine, and Acetaminophen Caplets for patients with acetaminophen allergy.

Acetaminophen is routinely used for short-term pain relief and fever in all stages of pregnancy.

Acetaminophen crosses the placenta and is believed to be safe in pregnancy when used intermittently for short durations. Isometheptene Mucate, Caffeine and Acetaminophen Caplets should only be given during pregnancy when need has been clearly established.

Isometheptene Mucate, Caffeine, and Acetaminophen caplets are supplied as white caplets debossed “BL 50” on one side and scored on the other side. Available in bottles of 50 caplets, NDC 35573-310-50.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, CALL A DOCTOR OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Avoid exposure to heat. Dispense in a tight, light-resistant container (USP/NF) with a child-resistant closure.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

􀀀Rx Only

Manufactured for:
Burel Pharmaceuticals, Inc.
Richland, MS 39218

Rev. 12/2015

NDC 35573-310-50

Isometheptene Mucate,

Caffeine, and

Acetaminophen

CAPLETS

EACH CAPLET CONTAINS

Isometheptene Mucate ......................................... 65 mg
Caffeine ............................................................... 20 mg
Acetaminophen .................................................. 325 mg

Rx Only

burelpharma

Net Contents: 50 Caplets