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What Are The Inactive Ingredients In Tylenol?

Understanding Tylenol's Ingredients

Dr. Erin Williams Profile Photo

Written by Dr. Erin Williams on July 30, 2021

Tylenol is one of the most well known and easily recognizable names in over the counter medications. Best known as a mild over the counter pain and fever medicine, Tylenol has expanded its brand throughout the years to include medications for many different types of pain, fever, cold, and flu.

The company manufactures products for adults and children in a variety of different forms, including caplets, liquids, liquid gels, and more. The medications are effective in treating mild to moderate pains caused by a variety of different medical conditions, and fever.

If you’re considering purchasing Tylenol to treat your pain, you might be wondering “what are Tylenol’s inactive ingredients?”

What is the difference between active and inactive ingredients?

If you’ve never given much thought to the ingredients in your medication before, you may not be aware that medications contain both active and inactive ingredients. The U.S. Food and Drug Administration provides the definitions of both active and inactive ingredients in 21 Code of Federal Regulations (CFR) 210.3,Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs, Part (b).

Under the terms of this federal guidance, an active ingredient is defined as any component of a drug product that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or animals.

To put it in more easily understood terms, the active ingredients in a medication are the ingredients that help relieve your symptoms and make you feel better.

Under 21 CFR 210.3, inactive ingredients are defined as any component of a drug product other than the active ingredient. In fact, inactive ingredients make up the majority – about 75 percent – of the average medication. Inactive ingredients may act as sweeteners, dissolving agents, binders, preservatives, flavoring, dyes, and more.

What are Tylenol’s active ingredients?

Tylenol is one of the most ubiquitous brand name medicines in the United States. Between children and adult formulas, Tylenol produces 28 different types of medication for the treatment of pain, fever, cold, and flu symptoms.

Although there are many different formulas, Tylenol Extra Strength Caplets for Adult Headache, Muscle Pain, and Fever Relief are among the most popular of the brand’s medications; this article describes the active and inactive ingredients in that particular formula.

Tylenol Extra Strength Caplets contain 500 mg of acetaminophen, the only active ingredient, in each tablet. Adults are directed to take two caplets every six hours while symptoms persist. Patients should not exceed six tablets in a 24-hour period unless otherwise directed by their doctor.

Acetaminophen is an over the counter medication that is most commonly used to diminish feelings of pain, discomfort, and fever in children and adults. Unlike other medications used for a similar purpose, acetaminophen is not a non-steroidal anti-inflammatory drug (NSAID), which means that it is associated with a lower risk of bleeding and gastrointestinal distress than medications like naproxen and ibuprofen.

Although acetaminophen is generally considered a safe medication when used as directed, it can cause serious side effects, including liver damage, when the drug is consumed in too large of a dose. Many different brands produce medications containing acetaminophen, and while Tylenol is the most popular, it is a common active ingredient. In some countries, acetaminophen is also sold under the generic name paracetamol. Acetaminophen should never be given to a child under the age of 2 without a doctor’s approval.

What are Tylenol’s inactive ingredients?

Tylenol Extra Strength Caplets contains the following inactive ingredients: carnauba wax, corn starch, FD&C red # 40 aluminum lake, hypromellose, magnesium stearate, modified starch, polyethylene glycol, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, and titanium dioxide.

Carnauba wax is an inactive ingredient that is commonly used to coat tablets and make it easier to swallow pills. The coating created by carnauba wax is made up primarily of fatty acid esters that create a slippery surface, allowing the medication to slide smoothly down your throat.

Corn starch and modified starch are inactive ingredients that are designed to act as disintegrants and binders within a given medication. Corn starch is derived from corn kernels and appears as a white to slightly yellowish fine powder, while modified starch can be produced from a number of different sources. Disintegrants are included in medications to help tablets to dissolve more efficiently, allowing the active ingredients to be released into the body.

FD&C red no. 40 aluminum lake is a type of synthetic dye that is commonly used in cosmetics and pharmaceutical products. Lake dyes are created when a chemical reaction between straight dyes, such as FD&C red no. 40, and a type of salt, such as aluminum, is caused. This inactive ingredient is used to provide coloring to the Tylenol caplets.

Hypromellose is the most commonly used cellulose. Cellulose is commonly included in medications to help control the release of the active ingredient and extend it over a long period of time in order to provide the therapeutic benefit for longer. Medications typically need to start working quickly to provide relief, but they also need to last long enough to make the patient feel better for a significant amount of time so that the drug does not need to be taken as often.

Magnesium stearate is one of the most common inactive ingredients in capsules and tablets. This substance is categorized as a flow agent and it is used to prevent the individual ingredients in a capsule or tablet from sticking to each other or to the machine that is used to manufacture the medication. Using magnesium stearate in a medication can also help to improve the drug’s consistency and delay the breakdown and absorption of the active ingredients, allowing them to be absorbed properly.

Pregelatinized starch is a multipurpose inactive ingredient that can act as a tablet diluent, glidant, disintegrant, or binder. Pregelatinized starch is most commonly used to help tablets like Tylenol disintegrate appropriately.

Propylene glycol is included in Tylenol as a binder. Medications use binders to keep the different ingredients of the drug together. Other common types of binders include different types of sugars, including cellulose or modified cellulose.

Shellac is commonly used to coat tablets and caplets like Tylenol. Coating a medication with a shellac helps the drug to break down at the right speed in the gastrointestinal tract, to release the active ingredient over the intended time period.

Sodium starch glycolate is a type of sodium salt that is derived from carboxymethyl ether. Sodium starch glycolate is commonly derived from sources like rice, potato, wheat, or corn, but it’s usually not possible to identify the source of the sodium starch glycolate that is included in the medication. This inactive ingredient is used in medication because it absorbs water quickly, which causes it to swell, contributing to the rapid disintegration of the tablet or caplet.

Titanium dioxide is a naturally occurring mineral that is commonly used in medications as a pigment for the coatings on tablets like Tylenol.

Are inactive ingredients associated with any risks?

The FDA lists most inactive ingredients as GRAS, or “generally recognized as safe.” This designation is used to refer to ingredients that do not cause an adverse effect in the majority of people when used as directed.

However, some people with certain allergies or sensitivities may find that they experience a reaction to these ingredients. While a variety of different reactions to inactive ingredients can occur, allergic reactions and digestive distress are among the most common experiences.

Digestive distress can appear as diarrhea, nausea, vomiting, constipation, abdominal pains, and more, while allergic reactions may present in the form of skin rash, irritation, hives, or even a severe type of allergic reaction called anaphylaxis, which can cause swelling of the face and airways and result in difficulty breathing.

Although you can experience an allergic reaction from taking just one medication, your likelihood of experiencing an adverse reaction to inactive ingredients increases as the number of medications that you take increases. The more medications you take, the more inactive ingredients you are exposed to and the more likely you are to experience an adverse reaction.

Summary

Tylenol Extra Strength Caplets contain 500 mg of acetaminophen per tablet as the active ingredient. Tylenol Extra Strength Caplets contains the following inactive ingredients: carnauba wax, corn starch, FD&C red # 40 aluminum lake, Hypromellose, magnesium stearate, modified starch, polyethylene glycol, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, and titanium dioxide.

All types of prescription and over the counter medications contain inactive ingredients, and while some people may not experience any adverse effects from certain inactive ingredients, others may experience allergic reactions or digestive distress.



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