Phrenilin with Caffeine and Codeine and XaQuil XR

• Generic Name: acetaminophen / butalbital / caffeine / codeine
• Dosage Forms: capsules
• Other Brand Names: Fioricet with Codeine, Phrenilin with Caffeine and Codeine

Butalbital, acetaminophen, caffeine, and codeine combination is used to relieve symptoms of tension (or muscle contraction) headaches. Extended and repeated use of this product is not recommended.

Butalbital belongs to the group of medicines called barbiturates. They act in the central nervous system (CNS) to produce their effects.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including serious liver damage. Although rare, use of acetaminophen has been reported to lead to liver transplantation and death, usually at high doses and when multiple acetaminophen-containing products have been used.

Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. Codeine belongs to the group of medicine called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When butalbital or codeine is used for a long time or in large doses, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics or barbiturates are used for this purpose. Physical dependence may lead to withdrawal side effects when you suddenly stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.

This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

• Generic Name: l-methylfolate
• Dosage Forms: n.a.
• Other Brand Names: Deplin, L-Methylfolate Formula, XaQuil XR, L-Methylfolate Formula 75

Folate is a form of B vitamin that occurs naturally in many foods. Folic acid is the man-made form of folate that is added to processed foods or vitamin and mineral supplements. Folate is needed in the human body for production of red blood cells.

A lack (deficiency) of folate in the human body can be caused by certain diseases, by taking certain medications, or by not getting enough folate in your diet. Folate deficiency can lead to decreased red blood cells, or anemia. Folate deficiency can also cause high levels of a certain amino acid in the blood, a condition called hyperhomocysteinemia (HYE-per-HOE-moe-sis-tin-EE-mee-a).

XaQuil XR is a medical food for use in people who have conditions related to folate deficiency. This medicine is also used in people with major depressive disorder who have folate deficiency, or in people with schizophrenia who have hyperhomocysteinemia related to folate deficiency.

XaQuil XR is not an antidepressant or anti-psychotic medication. However, this medicine may enhance the effects of antidepressant medications.

XaQuil XR may also be used for purposes not listed in this medication guide.