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 pres ...

headache A headache, also known as cephalalgia, 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 (mood), depression in those with severe ...

pain reliever An analgesic drug, also called simply an analgesic, antalgic, pain reliever, or painkiller, is any member of the group of drugs used for pain management. Analgesics are conceptually distinct from anesthetics, which temporarily reduce, and in so ...

, typically in the form of tablets or caplets. It contains paracetamol, aspirin and caffeine. It was manufactured by

Bristol-Myers Squibb The Bristol-Myers Squibb Company, doing business as Bristol Myers Squibb (BMS), is an American multinational pharmaceutical company. Headquartered in Princeton, New Jersey, BMS is one of the world's largest pharmaceutical companies and consist ...

until it was purchased by

Novartis Novartis AG is a Swiss multinational corporation, multinational pharmaceutical company, pharmaceutical corporation based in Basel, Switzerland. Novartis is one of the largest pharmaceutical companies in the world and was the eighth largest by re ...

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

. On July 18, 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 one of the largest consumer healthcare businesses in the world, with brands including Sensodyne toothpaste, Panadol and Advil pa ...

. 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, stress headache, or tension-type headache (TTH), is the most common type of primary headache. The pain usually radiates from the lower back of the head, the neck, the eyes, or other muscle groups in the body typically affecting b ...

s"). In 2007, the brand branched out into marketing for other types of pains with the introduction of Excedrin Back & Body, without caffeine.

Principles of work

Excedrin is a combination medication composed of

acetaminophen Paracetamol, or acetaminophen, is a non-opioid analgesic and antipyretic agent used to treat fever and mild to moderate pain. It is a widely available over-the-counter drug sold under various brand names, including Tylenol and Panadol. Parac ...

aspirin Aspirin () is the genericized trademark for acetylsalicylic acid (ASA), a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain, fever, and inflammation, and as an antithrombotic. Specific inflammatory conditions that aspirin is ...

, and

caffeine Caffeine is a central nervous system (CNS) stimulant of the methylxanthine chemical classification, class and is the most commonly consumed Psychoactive drug, psychoactive substance globally. It is mainly used for its eugeroic (wakefulness pr ...

. These medications treat migraine headache in a variety of ways.

Acetaminophen Paracetamol, or acetaminophen, is a non-opioid analgesic and antipyretic agent used to treat fever and mild to moderate pain. It is a widely available over-the-counter drug sold under various brand names, including Tylenol and Panadol. Parac ...

is a fever reducer and painkiller. Its precise mechanism is unknown. It is known that it mostly affects the

brain The brain is an organ (biology), organ that serves as the center of the nervous system in all vertebrate and most invertebrate animals. It consists of nervous tissue and is typically located in the head (cephalization), usually near organs for ...

and

spinal cord The spinal cord is a long, thin, tubular structure made up of nervous tissue that extends from the medulla oblongata in the lower brainstem to the lumbar region of the vertebral column (backbone) of vertebrate animals. The center of the spinal c ...

, which are parts of the central nervous system. By lowering the quantity of

prostaglandins Prostaglandins (PG) are a group of physiologically active lipid compounds called eicosanoids that have diverse hormone-like effects in animals. Prostaglandins have been found in almost every tissue in humans and other animals. They are derive ...

the body produces, acetaminophen raises the threshold for pain.

Aspirin Aspirin () is the genericized trademark for acetylsalicylic acid (ASA), a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain, fever, and inflammation, and as an antithrombotic. Specific inflammatory conditions that aspirin is ...

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 Caffeine is a central nervous system (CNS) stimulant of the methylxanthine chemical classification, class and is the most commonly consumed Psychoactive drug, psychoactive substance globally. It is mainly used for its eugeroic (wakefulness pr ...

acts as a

vasoconstrictor Vasoconstriction is the narrowing of the blood vessels resulting from contraction of the muscular wall of the vessels, in particular the large arteries and small arterioles. The process is the opposite of vasodilation, the widening of blood vesse ...

, causing blood vessels to become smaller. This helps to restrict the blood vessels in the brain. As a result, the amount of blood that may pass through the blood arteries at once is reduced. There are several theories regarding the cause and exacerbation of headaches, and it is thought by some that

vasodilation Vasodilation, also known as vasorelaxation, is the widening of blood vessels. It results from relaxation of smooth muscle cells within the vessel walls, in particular in the large veins, large arteries, and smaller arterioles. Blood vessel wa ...

may contribute to symptoms. If a headache is brought on by caffeine withdrawal, the caffeine content of Excedrin may relieve it.

Versions

Over the years, different forms of the drug have been introduced: * 1960: Excedrin Extra Strength (the formula changed for the last time in 1978) In 1960, Bristol-Myers, nowadays Bristol-Myers Squibb, introduced Excedrin Extra Strength for headaches, the first multi-ingredient headache treatment product. Contains 250 mg

, 250 mg

and 65 mg

. * 1969: Excedrin PM – Excedrin PM is the first headache and sleeping pill combination product. Contains 500 mg acetaminophen and 38 mg

diphenhydramine Diphenhydramine, sold under the brand name Benadryl among others, is an antihistamine and sedative. Although generally considered sedating, diphenhydramine can cause paradoxical central nervous system stimulation in some individuals, particula ...

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, sold under the brand names Neosynephrine and Sudafed PE among others, is a medication used as a decongestant for uncomplicated nasal congestion in the form of a nasal spray or oral tablet, to dilate the pupil, to increase bloo ...

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, which continued the trend of marketing pain products for specific types of pain, even though it had 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 United States. 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 Renal papillary necrosis is a form of nephropathy involving the necrosis of the renal papilla. Lesions that characterize renal papillary necrosis come from an impairment of the blood supply and from subsequent ischemic necrosis that is diffuse. Sig ...

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

for $660 million, in order to focus on drugs for the ten most profitable disease areas. As of March 2015,

GlaxoSmithKline GSK plc (an acronym from its former name GlaxoSmithKline plc) is a British Multinational corporation, multinational Pharmaceutics, pharmaceutical and biotechnology company with headquarters in London. It was established in 2000 by a Mergers an ...

held majority ownership through a joint venture transaction with

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 respo ...

. 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.

References

External links

* {{Haleon Combination analgesics Drug brand names Haleon brands Products introduced in 1960