Phrenilin with Caffeine and Codeine and Safetussin PM

• 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: dextromethorphan / doxylamine
• Dosage Forms: n.a.
• Other Brand Names: NyQuil Cough, Robitussin Maximum Strength Nighttime Cough DM, Robitussin Nighttime Cough DM, Safetussin PM, Robitussin Maximum Strength Nighttime Cough, Nighttime Cough

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Doxylamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Safetussin PM is used to treat cough, runny or stuffy nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.

Safetussin PM will not treat a cough that is caused by smoking, asthma, or emphysema.

Safetussin PM may also be used for purposes not listed in this medication guide.