Nucofed Pediatric Expectorant and Phrenilin with Caffeine and Codeine

• Generic Name: codeine / guaifenesin / pseudoephedrine
• Dosage Forms: n.a.
• Other Brand Names: Ambifed CD, Biotussin DAC, Cheratussin DAC, Guaifen DAC, Lortuss EX, Maxifed-G CD, Nucofed Pediatric Expectorant, Tricode GF, Tusnel C, Virtussin DAC, Virtussin DAC

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

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Nucofed Pediatric Expectorant is a combination medicine used to treat cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Nucofed Pediatric Expectorant will not treat a cough that is caused by smoking, asthma, or emphysema.

Nucofed Pediatric Expectorant may also be used for purposes not listed in this medication guide.

• 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.