US FDA The Food and Drug Administration is a government agency of the United States Department of Health and Human Services. The FDA is responsible for regulating and supervising the safety of foods, tobacco products, dietary supplements, prescription and non-prescription medication, vaccines, biopharmaceuticals, blood transfusions, medical devices,:link

Paracetamol (INN An International Nonproprietary Name is the official non-proprietary or generic name given to a pharmaceutical substance, as designated by the World Health Organization (WHO)[citation needed]. The plethora of named proprietary preparations containing a given substance can lead to confusion about the identity of the active ingredient. INNs) (pronounced /ˌpærəˈsiːtəmɒl, ˌpærəˈsɛtəmɒl/) or acetaminophen (/əˌsiːtəˈmɪnɵfɨn/ ( listen)) (USAN United States Adopted Names are unique nonproprietary names assigned to pharmaceuticals marketed in the United States. Each name is assigned by the USAN Council, which is co-sponsored by the American Medical Association , the United States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA)) is a widely used over-the-counter Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a health care professional, as compared to prescription drugs, which may only be sold to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they are ingredients that are analgesic An analgesic is any member of the group of drugs used to relieve pain (achieve analgesia). The word analgesic derives from Greek an- ("without") and algos ("pain"). Analgesic drugs act in various ways on the peripheral and central nervous systems; they include paracetamol (para-acetylaminophenol, also known in the US as (pain reliever) and antipyretic Antipyretics are drugs that reduce body temperature in situations such as fever. However, they will not affect the normal body temperature if one does not have a fever. Antipyretics cause the hypothalamus to override an interleukin-induced increase in temperature. The body will then work to lower the temperature and the result is a reduction in (fever reducer). However, its effectiveness alone as an antipyretic has been questioned.^[1] It is commonly used for the relief of headaches In medicine, a headache or cephalalgia is a symptom of a number of different conditions of the head. Headache is caused by a disturbance of the pain-sensitive structures in the head. The brain in itself is not sensitive to pain, because it lacks nociceptors. Several areas of the head and neck have the pain-sensitive structures. The pain-sensitive, and other minor aches and pains, and is a major ingredient in numerous cold The common cold (viral upper respiratory tract infection , acute viral rhinopharyngitis, acute coryza, or cold) is a contagious, viral infectious disease of the upper respiratory system, caused primarily by rhinoviruses and coronaviruses. Common symptoms include a sore throat, runny nose, and fever. There is no cure, however symptoms usually and flu Influenza, commonly referred to as the flu, is an infectious disease caused by RNA viruses of the family Orthomyxoviridae , that affects birds and mammals. The most common symptoms of the disease are chills, fever, sore throat, muscle pains, severe headache, coughing, weakness/fatigue and general discomfort. Sore throat, fever and coughs are the remedies. In combination with opioid analgesics An opioid is a chemical that works by binding to opioid receptors, which are found principally in the central nervous system and the gastrointestinal tract. The receptors in these two organ systems mediate both the beneficial effects, and the side effects of opioids, paracetamol could be used also in the management of more severe pain (such as in advanced cancer).^[2]

While generally safe for human use at recommended doses (1,000 mg per single dose and up to 4,000 mg per day for adults, up to 2,000 mg per day if drinking alcohol^[3]), acute overdoses The term drug overdose describes the ingestion or application of a drug or other substance in quantities greater than are recommended or generally practiced. An overdose is widely considered harmful and dangerous as it can result in death of paracetamol can cause potentially fatal liver damage Hepatotoxicity implies chemical-driven liver damage. The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents when taken in overdoses and sometimes even when introduced within therapeutic ranges may injure the organ. Other chemical agents such as those used and, in rare individuals, a normal dose can do the same; the risk is heightened by alcohol consumption Ethanol, also called ethyl alcohol, pure alcohol, grain alcohol, or drinking alcohol, is a volatile, flammable, colorless liquid. It is a powerful psychoactive drug, best known as the type of alcohol found in alcoholic beverages and in modern thermometers. Ethanol is one of the oldest recreational drugs. In common usage, it is often referred to. Paracetamol toxicity Paracetamol toxicity is caused by excessive use or overdose of the analgesic drug paracetamol . Mainly causing liver injury, paracetamol toxicity is one of the most common causes of poisoning worldwide. In the United States and the United Kingdom it is the most common cause of acute liver failure is the foremost cause of acute liver failure Acute liver failure is the appearance of severe complications rapidly after the first signs of liver disease , and indicates that the liver has sustained severe damage (loss of function of 80-90% of liver cells). The complications are hepatic encephalopathy and impaired protein synthesis (as measured by the levels of serum albumin and the in the Western world The Western world, also known as the West and the Occident , is a term that can have multiple meanings depending on its context (e.g., the time period, the region or social situation). Accordingly, the basic definition of what constitutes "the West" varies, expanding and contracting over time, in relation to various historical, and accounts for most drug overdoses in the United States, the United Kingdom, Australia and New Zealand.^[4][5][6][7]

Paracetamol is derived from coal tar Coal tar is a brown or black liquid of high viscosity, which smells of naphthalene and aromatic hydrocarbons. Coal tar is among the by-products when coal is carbonized to make coke or gasified to make coal gas. Coal tars are complex and variable mixtures of phenols, polycyclic aromatic hydrocarbons , and heterocyclic compounds, and is part of the class of drugs known as "aniline Aniline, phenylamine or aminobenzene is an organic compound with the formula C6H7N. It is the simplest and one of the most important aromatic amines, being used as a precursor to more complex chemicals. Its main application is in the manufacture of polyurethane. Like most volatile amines, it possesses the somewhat unpleasant odour of rotten fish analgesics"; it is the only such drug still in use today.^[8] It is the active metabolite of phenacetin Phenacetin, is an analgesic, but its use has declined owing to its association with several adverse side effects, some of which are described following. Typical doses are 300mg to 500mg a day, once popular as an analgesic and antipyretic in its own right, but unlike phenacetin and its combinations, paracetamol is not considered to be carcinogenic A carcinogen is any substance, radionuclide or radiation that is an agent directly involved in the exacerbation of cancer or in the increase of its propagation. This may be due to the ability to damage the genome or to the disruption of cellular metabolic processes. Several radioactive substances are considered carcinogens, but their carcinogenic at therapeutic doses.^[9] The words acetaminophen (used in the United States, Canada, Hong Kong, Iran^[10], Colombia and other Latin American countries) and paracetamol (used elsewhere) both come from chemical names for the compound: para-acetylaminophenol and para-acetylaminophenol. In some contexts, it is simply abbreviated as APAP, for N-acetyl-para-aminophenol.

There is confusion in terminology of paracetamol. It could be considered a nonsteroidal antiinflammatory drugs (NSAID Nonsteroidal anti-inflammatory drugs, usually abbreviated to NSAIDs or NAIDs, are drugs with analgesic, antipyretic and, in higher doses, with anti-inflammatory effects (reducing inflammation). The term "nonsteroidal" is used to distinguish these drugs from steroids, which (among a broad range of other effects) have a similar eicosanoid-), but paracetamol has very little anti-inflammatory effect in many tissues. However aspirin, paracetamol and other NSAIDs all act by the same mechanism (inhibition of prostaglandin A prostaglandin is any member of a group of lipid compounds that are derived enzymatically from fatty acids and have important functions in the animal body. Every prostaglandin contains 20 carbon atoms, including a 5-carbon ring. They are mediators and have a variety of strong physiological effects, such as regulating the contraction and (PG) synthesis) and all show varying levels of analgesic, anti-inflammatory, antipyretic and antiplatelet actions.^[11]

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