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Tylenol // is an American brand of drugs advertised for reducing pain, reducing fever, and relieving the symptoms of allergies, cold, cough, and flu. The active ingredient of its original flagship product is acetaminophen, an analgesic and antipyretic; it is commonly known elsewhere in the world by its international nonproprietary name, paracetamol. Like the words "acetaminophen" and "paracetamol", the brand name "tylenol" is derived from the chemical name for the compound, N-acetyl-para-aminophenol (APAP). The brand name "tylenol" is owned by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson.
James Roth, a U.S. gastroenterologist, advocated paracetamol as a gastric-friendly alternative to aspirin, which can irritate the stomach when taken without food. Roth was also principal consultant to McNeil Laboratories. In 1953, McNeil Laboratories introduced Algoson, a preparation containing paracetamol together with sodium butabarbital, a sedative. In 1955, McNeil Laboratories introduced Tylenol Elixir for children, which contained paracetamol as its sole active ingredient. It was originally marketed mainly towards children, but soon came to dominate the North American pain-killer market. There are a number of different varieties of Tylenol available today including extra-strength (with 500 milligrams of paracetamol), children's doses, longer-lasting, and sleep aiding (in combination with diphenhydramine). In 2005, Tylenol Ultra was introduced in Canada, with 500 mg of paracetamol and 65 mg of caffeine; caffeine has vasoconstricting effects, for which there is some disputed evidence for additional effectiveness. The patent on paracetamol has long expired, and the continued success of Tylenol brand preparations are largely due to marketing, the backing and reputation of Johnson & Johnson, and new patented delivery mechanisms such as quick-release and extended-release forms of the medication.
On September 29, 1982, a "Tylenol scare" began when the first of seven individuals died in metropolitan Chicago, after ingesting Extra Strength Tylenol that had been deliberately contaminated with cyanide. Within a week, the company pulled 31 million bottles of tablets back from retailers, making it one of the first major recalls in American history.
As a result of the crisis, all Tylenol capsules were discontinued, as were capsules of other brand names. Retained by McNeil President Joseph Chiesa, new product consultant Martin Calle and management strategist Calle & Company conceived the world's first tamper-proof gelatin-enrobed capsule called "Tylenol Gelcaps", which proved to resuscitate the 92% of capsule-segment sales lost to the recall. The tamper-proof, triple-sealed safety containers were swiftly placed on the shelves of retailers 10 weeks after the withdrawal, and other manufacturers followed suit. The crisis cost the company more than $100 million, but Tylenol regained 100% of the market share it had before the crisis. The Tylenol murderer was never found, and a $100,000 reward offered by Johnson & Johnson still remains unclaimed.
Tylenol remains a top seller, controlling about 35% of the pain killer market in North America, according to a study published in 2003.
On January 15, 2010, 20 months after first receiving consumer complaints, Johnson & Johnson announced a voluntary recall of several hundred batches of popular medicines, including Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol. The recall was due to complaints of a musty smell which is suspected to be due to contamination of the packaging with the chemical 2,4,6-tribromoanisole. The full health effects of 2,4,6-tribromoanisole are not known but no serious events have been documented in medical literature. The recall came 20 months after McNeil first began investigating consumer complaints about moldy-smelling bottles of Tylenol Arthritis Relief caplets, according to the United States Food and Drug Administration. The recall included 53 million bottles of over-the-counter products including Tylenol, Motrin and Rolaids, Benadryl and St. Joseph's Aspirin, involving lots in the Americas, the United Arab Emirates and Fiji.
On April 30, 2010, another recall was issued for 40 products including liquid infant and children's pain relievers, Tylenol, and Motrin and allergy medications Zyrtec and Benadryl. A Food and Drug Administration report said its inspectors found thick dust and grime covering certain equipment, a hole in the ceiling and duct tape-covered pipes at the Fort Washington, Pennsylvania, facility that made 40 products recalled.
On Wednesday, May 5, 2010, the Food and Drug Administration (FDA) confirmed that the bacteria found at the Johnson & Johnson plant that made the recalled Children's Tylenol was Burkholderia cepacia, a bacteria often resistant to common antibiotics. The CDC has stated that Burkholderia cepacia is not likely to cause health problems for those with healthy immune systems but those with weaker ones and those with chronic lung diseases, such as cystic fibrosis, could be more susceptible to infection.
Tylenol is also sold as a class of stronger pain relievers containing codeine, known as co-codamols: Tylenol 1 contains 325 mg acetaminophen and 8 mg codeine; Tylenol 2 contains 300 mg/15 mg, Tylenol 3 (300 mg/30 mg), and Tylenol 4 (300 mg/60 mg). In Canada, Tylenol 1, 2 and 3 all include 15 mg caffeine, in addition to the above ingredients; furthermore, Tylenol 1 is sold in Canada without a prescription, while all forms of Tylenol with codeine require a prescription in the US.
Tylenol PM is the trademark for a mixture of acetaminophen (paracetamol) and diphenhydramine, distributed by Johnson & Johnson. It is marketed as a combined analgesic and sedative. It is listed as non-habit forming. Diphenhydramine is an anticholinergic used as the active ingredient in Benadryl, for its antihistamine properties, and Benylin, which is used in cough and cold therapy as an antitussive (anti-cough) medication.
The dangers of acetaminophen, especially in combination with alcohol, have been reported in the medical literature since the 1960s, although they were not always disclosed on the Tylenol labeling and packaging. These dangers were reported in a September 2013 episode of This American Life entitled "Use Only as Directed" and in two investigative articles in ProPublica
This American Life reported that "acetaminophen, the active ingredient in Tylenol ... kills the most people [of any over-the-counter drug], according to data from the federal government. Over 150 Americans die each year".
ProPublica reported that the "FDA has long been aware of studies showing the risks of acetaminophen. So has the maker of Tylenol, McNeil Consumer Healthcare, a division of Johnson & Johnson" and "McNeil, the maker of Tylenol ... has repeatedly opposed safety warnings, dosage restrictions and other measures meant to safeguard users of the drug." This included warnings of liver damage and warnings about using acetaminophen in combination with alcohol. This is especially dangerous because of acetaminophen's narrow safety margin. ProPublica interviewed a man who had liver failure after using Tylenol in the recommended dose and drinking two or three glasses of wine, at a time when the Tylenol label didn't mention any dangers of drinking.
Acetaminophen, including Tylenol, causes three times as many cases of liver failure as all other drugs combined, and is the most common cause of acute liver failure in the United States, accounting for 39% of cases.
Tylenol has many different advertisement approaches. One of these advertisement campaigns focuses on "getting you back to normal", whereas the other commercials focus on Tylenol's current slogan, "Feel better, Tylenol". In the "Feel better, Tylenol" commercials, Tylenol places emphasis on the importance of sleep; various people are seen sleeping in this commercial while a voiceover describes how sleep can help repair and heal the human body during times of aches and pains. In the "getting you back to normal" commercial, Tylenol places more emphasis on helping its consumers get back to their daily routines; many different people are shown first experiencing headaches and other sorts of body pain, where a voiceover then states that Tylenol Rapid Release can help rid aches and pains; the various people are then showed enjoying their everyday lives, and are seen as "back to normal".
In an older commercial from 1986, Tylenol emphasized that it is the drug that American hospitals trust the most. In this ad, Susan Sullivan told the consumer that Tylenol was a drug that could be trusted by Americans since many doctors also trusted it; she went on to state that doctors prescribed Tylenol four times more often than the other leading pain relieving drugs combined.