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Excedrin is an
over-the-counter Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescr ...
headache Headache is the symptom of pain in the face, head, or neck. It can occur as a migraine, tension-type headache, or cluster headache. There is an increased risk of depression in those with severe headaches. Headaches can occur as a result ...
pain reliever, typically in the form of tablets or caplets. It contains
paracetamol Paracetamol, also known as acetaminophen, is a medication used to treat fever and mild to moderate pain. Common brand names include Tylenol and Panadol. At a standard dose, paracetamol only slightly decreases body temperature; it is inferior ...
(acetaminophen),
aspirin Aspirin, also known as acetylsalicylic acid (ASA), is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain, fever, and/or inflammation, and as an antithrombotic. Specific inflammatory conditions which aspirin is used to treat inc ...
, and
caffeine Caffeine is a central nervous system (CNS) stimulant of the methylxanthine class. It is mainly used recreationally as a cognitive enhancer, increasing alertness and attentional performance. Caffeine acts by blocking binding of adenosine t ...
. It was manufactured by
Bristol-Myers Squibb The Bristol Myers Squibb Company (BMS) is an American multinational pharmaceutical company. Headquartered in New York City, BMS is one of the world's largest pharmaceutical companies and consistently ranks on the ''Fortune'' 500 list of the lar ...
until it was purchased by
Novartis Novartis AG is a Swiss-American multinational pharmaceutical corporation based in Basel, Switzerland and Cambridge, Massachusetts, United States (global research).name="novartis.com">https://www.novartis.com/research-development/research-loc ...
in July, 2005 along with other products from BMS's over-the-counter business. As of March 2015, GSK holds majority ownership of Excedrin through a joint venture transaction with
Novartis Novartis AG is a Swiss-American multinational pharmaceutical corporation based in Basel, Switzerland and Cambridge, Massachusetts, United States (global research).name="novartis.com">https://www.novartis.com/research-development/research-loc ...
. On 18 July 2022, GSK spun off its consumer healthcare business (including Excedrin) to
Haleon Haleon plc is a British multinational consumer healthcare company with headquarters in Weybridge, England. It is the largest consumer healthcare business in the world, with brands including Sensodyne toothpaste, Panadol Paracetamol, also kno ...
. The brand became known for advertisements where it cured especially unpleasant and excruciating headaches (called "Excedrin headaches" in the ads of 1970s, and later called "Excedrin
tension headache Tension headache, also known as stress headache, or tension-type headache (TTH), is the most common type of primary headache. The pain can radiate from the lower back of the head, the neck, eyes or other muscle groups in the body typically affect ...
s"). In 2007, the brand branched out into marketing for other types of pains with the introduction of Excedrin Back & Body, without caffeine. Excedrin is mentioned in
Stephen King Stephen Edwin King (born September 21, 1947) is an American author of horror, supernatural fiction, suspense, crime, science-fiction, and fantasy novels. Described as the "King of Horror", a play on his surname and a reference to his high s ...
's the 1977 novel '' The Shining'', as a headache remedy for
Jack Torrance John Daniel Edward "Jack" Torrance is the main antagonist in Stephen King's horror novel '' The Shining'' (1977). He was portrayed by Jack Nicholson in the novel's 1980 film adaptation, by Steven Weber in the 1997 miniseries, by Brian Mu ...
.


Principles of work

Excedrin is a combined medication. It comprises acetaminophen, aspirin, and caffeine, three separate medications. These medications treat migraine headache in a variety of ways. Acetaminophen is a fever reducer and painkiller. Its precise mechanism is unknown. We do know that it mostly affects the brain and spinal cord, which are parts of the central nervous system. By lowering the quantity of prostaglandins your body produces, acetaminophen raises the threshold for pain. A molecule associated with pain is called a prostaglandin. Aspirin is a nonsteroidal anti-inflammatory drug (NSAID). It lessens irritation and swelling as well as discomfort and inflammation. The amount of prostaglandins the body produces is also decreased by aspirin, but not in the same way that acetaminophen does. Caffeine acts as a vasoconstrictor instead. Thus, it causes blood vessels to become smaller. Caffeine helps to restrict the blood vessels in your brain in Excedrin Migraine. The amount of blood that may pass through the blood arteries at once is reduced as a result. The widening of blood arteries that causes headaches is prevented by this process. If a headache is brought on by caffeine withdrawal, caffeine also relieves it.


Versions

Over the years, different types of the drug were introduced: * 1960: Excedrin Extra Strength (the formula changed for the last time in 1978) In 1960, Bristol-Myers Squibb introduced Excedrin Extra Strength for headaches, the first multi-ingredient formulation headache treatment product. Contains 250 mg acetaminophen, 250 mg
aspirin Aspirin, also known as acetylsalicylic acid (ASA), is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain, fever, and/or inflammation, and as an antithrombotic. Specific inflammatory conditions which aspirin is used to treat inc ...
and 65 mg
caffeine Caffeine is a central nervous system (CNS) stimulant of the methylxanthine class. It is mainly used recreationally as a cognitive enhancer, increasing alertness and attentional performance. Caffeine acts by blocking binding of adenosine t ...
* 1969: Excedrin PM – The first headache and sleeping pill combined product. Contains 500 mg acetaminophen and 38 mg
diphenhydramine Diphenhydramine (DPH) is an antihistamine and sedative mainly used to treat allergies, insomnia, and symptoms of the common cold. It is also less commonly used for tremor in parkinsonism, and nausea. It is taken by mouth, injected into a vein ...
citrate as a sleep aid. Those same active ingredients were later utilized several years later in the product Tylenol PM. * 1998: Excedrin Migraine – At the beginning of 1998, the FDA granted clearance to market Excedrin Migraine for the relief of migraine headache pain and associated symptoms. Excedrin Migraine continued the trend of marketing pain products for specific types of pain, becoming the first migraine headache medication available to consumers without a prescription, even though it has identical ''active'' ingredients to the regular Excedrin Extra Strength product, 250 mg acetaminophen, 250 mg aspirin, and 65 mg caffeine. In fact, upon the product's launch, its advertising slogan was “Excedrin is now Excedrin Migraine,” noting that the two were the same product. * 2003: Excedrin Tension Headache contains 500 mg acetaminophen, and 65 mg caffeine. * 2005: Excedrin Sinus Headache contains 325 mg acetaminophen and 5 mg
phenylephrine Phenylephrine is a medication primarily used as a decongestant, to dilate the pupil, to increase blood pressure, and to relieve hemorrhoids. In the United States, it was previously used orally as an over-the-counter decongestant to relieve nas ...
HCl as a decongestant. * 2007: Excedrin Back and Body – a dual-ingredient formula claiming that it "works two ways—as a pain reliever and a pain blocker right where it hurts". Contains 250 mg acetaminophen, 250 mg aspirin. * Discontinued – Excedrin Menstrual Complete Excedrin Menstrual Complete continues the trend of marketing pain products for specific types of pain, even though it has identical active ingredients to the regular Excedrin Extra Strength product and Excedrin Migraine, 250 mg acetaminophen, 250 mg aspirin and 65 mg caffeine.


Canada

Excedrin is no longer sold in Canada. Previously, Excedrin Migraine and Excedrin Extra Strength sold in Canada had a different formulation compared to the US. In Canada the product sold with those names contained 500 mg of acetaminophen and 65 mg of caffeine per tablet. The reason was that the combination of acetaminophen with aspirin creates the risk of renal papillary necrosis if large doses are taken chronically.


Ownership

In 2005, Bristol-Myers Squibb announced the sale of its North American consumer medicine business (including Excedrin, Comtrex and Keri brands) to
Novartis Novartis AG is a Swiss-American multinational pharmaceutical corporation based in Basel, Switzerland and Cambridge, Massachusetts, United States (global research).name="novartis.com">https://www.novartis.com/research-development/research-loc ...
for $660 million, in order to focus on drugs for the ten most profitable disease areas. As of March 2015,
GlaxoSmithKline GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the ten ...
held majority ownership through a joint venture transaction with
Novartis Novartis AG is a Swiss-American multinational pharmaceutical corporation based in Basel, Switzerland and Cambridge, Massachusetts, United States (global research).name="novartis.com">https://www.novartis.com/research-development/research-loc ...
.


Recall and production stoppage


2012 recall

On January 9, 2012, Novartis announced that it was voluntarily recalling all lots of select bottle-packaging configurations of Excedrin products with expiration dates of December 20, 2014, or earlier as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets. The recall was conducted with the knowledge of the U.S.
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
. Wholesalers and retailers were instructed to stop distribution and return the affected product. Consumers in possession of recalled Excedrin were instructed to stop using the product and contact Novartis. Novartis stated that Excedrin would be shipping to stores on October 15, 2012, and that customers would start seeing it by the first of November.


January 2020 production stoppage

On January 21, 2020, GlaxoSmithKline announced that production and distribution of caplets and gel tabs of Excedrin Extra Strength and Excedrin Migraine would be stopped temporarily. Their statement said, "Through routine quality control and assurance measures, we discovered inconsistencies in how we transfer and weigh ingredients" for the recalled products, and that production would restart "shortly". However, GSK acknowledged that they "cannot confirm a definite date as to when supply will resume".


December 2020 recall

On December 26, 2020 The U.S. Consumer Product Safety Commission announced the recall of 400,000 bottles of Excedrin due to the containers of the drug allegedly having holes in the bottom. The concern behind the recall was that the plastic bottles, if they had a hole, could allow children to access the painkiller caplets and lead to dangerous overdose or poisoning. The recall involved bottles containing 50, 80, 100, 152, 200, 250, or 300 caplets.


See also

* Stella Nickell, who tampered with Excedrin tablets


References

{{Haleon Combination drugs Haleon Products introduced in 1960