acetaminophen / phenylephrine / dextromethorphan / guaifenesin
Tylenol Cold and Flu Severe is an over-the-counter (OTC) combination medication containing acetaminophen (pain killer), dextromethorphan (cough suppressant), guaifenesin (expectorant), and phenylephrine (decongestant). It's used to temporarily relieve multiple cold and flu symptoms, like sore throat, cough, congestion, fever, and minor aches, for people 12 years and older. Tylenol Cold and Flu Severe is typically taken by mouth every 4 hours as needed. This medication doesn't commonly cause side effects, but watch out for nausea, belly discomfort, and headache.
What is Tylenol Cold and Flu Severe?
What is Tylenol Cold and Flu Severe used for?
Short-term relief of common cold and flu symptoms, including:
Stuffy nose
Sinus congestion and pressure
Chest congestion
Cough
Sore throat
Minor aches and pains
Headache
Fever
How Tylenol Cold and Flu Severe works
Tylenol Cold and Flu Severe is a combination of four medications.
Acetaminophen is an analgesic. It relieves pain and lowers fever by stopping the production of certain inflammatory chemicals in the brain.
Dextromethorphan is a cough suppressant that works in the part of your brain that makes you cough. It calms down this part of the brain and tells your body to cough less.
Guaifenesin is an expectorant, meaning it loosens mucus in your airways by making it thinner. This makes it easier to cough out mucus and helps clear chest congestion.
Phenylephrine is a decongestant that works to clear stuffy nose and sinuses by tightening the blood vessels in your nose.
Drug Facts
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What are the side effects of Tylenol Cold and Flu Severe?
Common Side Effects
- Side effects aren't common. See Other Side Effects.
Other Side Effects
- Nausea
- Headache
- Belly discomfort
- Vomiting
- Drowsiness
- Diarrhea
- Dizziness
- Anxiety or nervousness
- Headache
- Trouble sleeping
- Fast heartbeat
Serious Side Effects
- Liver damage: nausea, vomiting, loss of appetite, severe stomach pain, yellowing of the skin or whites of the eyes
- Serotonin syndrome: fast heart rate, sweating, muscle stiffness or spasms, high fever, confusion
- Severe skin reaction: skin reddening, blisters, rash
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Heart palpitations—rapid, pounding, or irregular heartbeat
- Increase in blood pressure
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Redness, blistering, peeling, or loosening of the skin, including inside the mouth
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Tylenol Cold and Flu Severe
Pros
Conveniently combines four medications into one product to treat many cold and flu symptoms
Available over the counter without a prescription
Available as a tablet and liquid
Cons
Might need to take multiple times a day for optimal relief
Might raise blood pressure
Not safe for use in young children
Pharmacist tips for Tylenol Cold and Flu Severe
For Tylenol Cold and Flu Severe liquid: Be sure to use the medication dose cup, spoon, or oral syringe that comes in the packaging to measure out the dose. Ask your pharmacy if you need extras. Don't use household spoons because they might not be accurate; you might take the wrong amount of medication if you use them.
Tylenol Cold and Flu Severe liquid contains sodium. Avoid taking the liquid form of the medication if you're following a low-sodium diet.
It's best to limit how much alcohol you drink while you're taking Tylenol Cold and Flu Severe to help lower the risk for liver problems. This medication contains acetaminophen. Too much alcohol (3 drinks or more daily) and acetaminophen can seriously harm the liver.
Tell your primary care provider if you have a long-lasting cough that's caused by cigarette smoke or bronchitis, a cough that's related to a breathing problem (e.g., asthma, emphysema), or a cough with a lot of mucus. Tylenol Cold and Flu Severe might not be appropriate for these types of coughs.
Talk with your primary care provider if your cough gets worse, comes back after clearing up, or lasts more than a week. Also let them know if you also have a rash or headache with your cough. These might be signs of a more serious medical condition that requires other treatment.
Stop taking Tylenol Cold and Flu Severe and call your primary care provider if your body aches or stuffy nose gets worse or lasts longer than 7 days. Also stop and contact your primary care provider if your fever gets worse or lasts for more than 3 days. You might need to get examined to see whether you need other treatment.
Stop taking Tylenol Cold and Flu Severe and let your primary care provider know if you notice any mood changes, trouble sleeping, redness, swelling, or new symptoms.
Stop taking Tylenol Cold and Flu Severe if you have a severe sore throat, if it lasts for more than 2 days, or if it happens along with fever, headache, rash, nausea, or vomiting. These can be symptoms of a more serious medical condition that requires medical attention.
Many other medications contain acetaminophen, dextromethorphan, guaifenesin, and phenylephrine, the same ingredients in Tylenol Cold and Flu Severe. Read package labels carefully and don't use multiple products with the same ingredients. This helps lower the risk of accidentally taking too much and serious side effects, like hallucinations, slow breathing, seizure, and liver damage (e.g., yellowing of eyes or skin). Get medical help right away if you have these side effects.
Keep Tylenol Cold and Flu Severe up and away and out of children's reach and sight. Always put medication away every time you use it. This prevents children from accidentally swallowing any medication that's left out. Call a Poison Center at 1-800-222-1222 right away if a child might’ve accidentally swallowed the medication, even if you aren't completely sure.
Frequently asked questions about Tylenol Cold and Flu Severe
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What are the risks and warnings for Tylenol Cold and Flu Severe?
Tylenol Cold and Flu Severe can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Liver damage
Risk factors: Drinking 3 or more alcoholic beverages a day | Taking with other acetaminophen-containing medications | History of liver problems
Tylenol Cold and Flu Severe contains acetaminophen. Taking too much acetaminophen can cause severe and sometimes life-threatening liver damage. For healthy adults, the maximum amount of acetaminophen is typically 4 grams in a 24-hour period, though it could be lower depending on your liver health and your primary care provider's instructions. Be sure to keep track of how much acetaminophen you're taking throughout the day to lessen the risk for liver damage.
Talk to your primary care provider before starting Tylenol Cold and Flu Severe if you have a history of liver problems, since this medication might further damage your liver. Also avoid drinking alcohol while you're taking Tylenol Cold and Flu Severe because taking this medication with alcohol can put you at higher risk for liver damage.
Get medical attention right away if you notice any signs of liver problems, including feeling tired, upset stomach, stomach pain, dark urine, or yellowing of skin or whites of the eyes.
Risk of taking too much medication
There are many over-the-counter medications that contain the same or similar ingredients in Tylenol Cold and Flu Severe (acetaminophen, phenylephrine, dextromethorphan, and guaifenesin). In addition, some prescription pain medications have acetaminophen in them.
Taking more than one product containing similar ingredients raises the risk that you might accidentally take too much medication. This can cause serious and sometimes life-threatening side effects. For example, taking too much acetaminophen can raise your risk for severe liver damage. Also, taking too much dextromethorphan can lead to hallucinations and trouble breathing.
Talk to your care team before you start Tylenol Cold and Flu Severe if you're not sure whether you're already taking a product with similar medications in it. To prevent an accidental overdose, carefully follow the product instructions on the package. Call your Poison Control Center at 1-800-222-1222 right away if you or anyone else might’ve accidentally taken too much Tylenol Cold and Flu Severe, even if you aren't completely sure.
Interaction with monoamine oxidase inhibitors (MAOIs)
Risk factor: Currently take or have taken an MAOI in the last 14 days
Talk to your primary care provider first before using Tylenol Cold and Flu Severe if you're taking or have recently taken medications for Parkinson's disease or depression known as monoamine oxidase inhibitors (MAOIs).
MAOIs can interact with the dextromethorphan that's in Tylenol Cold and Flu Severe. This drug interaction can cause dangerously high blood pressure. It can also lead to a rare, but serious side effect called serotonin syndrome. Ask your primary care provider about other options to relieve your cold and flu symptoms if you've taken an MAOI in the past two weeks.
Serious skin reaction
In some rare cases, acetaminophen in Tylenol Cold and Flu Severe can cause serious skin reactions. Stop using Tylenol Cold and Flu Severe and get medical attention right away if you notice a rash, blisters, or skin reddening after you take the medication.
Worsening of certain medical conditions
Risk factors: Liver problems | Heart problems | High blood pressure | Thyroid problems | Diabetes | Trouble urinating | Long-term cough | Cough with too much mucus
Speak to your primary care provider or pharmacist first before using Tylenol Cold and Flu Severe if you have other medical conditions to make sure this medication is safe and appropriate for you. You might need other treatment if you have a cough with a lot of mucus or long-term coughing caused by conditions like asthma, emphysema, smoking, and bronchitis. In addition, it's possible for this medication to worsen certain medical conditions, such as liver problems, heart problems, high blood pressure, thyroid problems, diabetes, or trouble urinating.
Tylenol Cold and Flu Severe dosage forms
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 177ml of 650mg/10mg/20mg/400mg/20ml | 1 bottle | $5.50 | $5.50 |
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 355ml of 325mg/5mg/10mg/200mg/15ml | 1 bottle | $7.06 | $7.06 |
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 325mg/5mg/10mg/200mg | 30 tablets | $5.72 | $0.19 |
Typical dosing for Tylenol Cold and Flu Severe
Note: Several manufacturers make this medication under different brand names, in different forms, and in different strengths. Follow the specific product instructions on the package or talk with your primary care provider or pharmacist about how to take this medication.
Tylenol Cold and Flu Severe liquid
Each 30 mL of liquid contains 650 mg of acetaminophen, 20 mg of dextromethorphan, 400 mg of guaifenesin, and 10 mg of phenylephrine.
Adults and children 12 years and older: The typical dose is 30 mL by mouth every 4 hours as needed for cold and flu symptoms. Don't take more than 5 doses (or 150 mL) in a 24-hour period.
Children under age 12: Don't use. Ask your child's pediatrician for other options.
Tylenol Cold and Flu Severe tablets
Each tablet contains 325 mg of acetaminophen, 10 mg of dextromethorphan, 200 mg of guaifenesin, and 5 mg of phenylephrine.
Adults and children 12 years and older: The typical dose is 2 tablets by mouth every 4 hours as needed for cold and flu symptoms. Don't take more than 10 tablets in a 24-hour period.
Children under age 12: Don't use. Ask your child's pediatrician for other options.
How much does Tylenol Cold and Flu Severe cost?
Tylenol Cold and Flu Severe contraindications
Taking acetaminophen or products that contain acetaminophen
Currently taking or have taken an MAOI in the last 14 days
What are alternatives to Tylenol Cold and Flu Severe?
Short-term relief of common cold and flu symptoms, including:
Stuffy nose
Sinus congestion and pressure
Chest congestion
Cough
Sore throat
Minor aches and pains
Headache
Fever
Loosen phlegm (mucus) in the lungs to make it easier to cough up
Short-term relief of cough and stuffy nose (nasal congestion)
Short-term relief of symptoms from the common cold and flu:
What is the latest news about Tylenol Cold and Flu Severe?
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References
Best studies we foundAlbrecht, H. H., et al. (2017). Role of guaifenesin in the management of chronic bronchitis and upper respiratory tract infections. Multidisciplinary Respiratory Medicine.
Centers for Disease Control and Prevention. (2024). Alcohol.
Dolansky, G., et al. (2008). What is the evidence for the safety and efficacy of over-the-counter cough and cold preparations for children younger than six years of age? Paediatrics & Child Health.
Gerriets, V., et al. (2024). Acetaminophen. StatPearls.
Johnson & Johnson Consumer Inc. (2024). Tylenol Cold Plus Flu Severe- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution [package insert]. DailyMed.
Johnson & Johnson Consumer Inc. (2024). Tylenol Cold Plus Flu Severe- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coated [package insert]. DailyMed.
Oh, S., et al. (2023). Dextromethorphan. StatPearls.
Procter & Gamble Manufacturing Company. (2023). Dayquil Vapocool Severe Cold and Flu Plus Congestion- acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and guaifenesin solution [package insert]. DailyMed.
Spangler, D. C., et al. (2016). Dextromethorphan: A case study on addressing abuse of a safe and effective drug. Substance Abuse Treatment, Prevention, and Policy.
Thomas, S. J., et al. (2015). Combination therapy with monoamine oxidase inhibitors and other antidepressants or stimulants: Strategies for the management of treatment-resistant depression. Pharmacotherapy.
U.S. Food and Drug Administration. (2016). FDA Drug Safety Communication: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen.
Woo, T., et al. (2008). Pharmacology of cough and cold medicines. Journal of Pediatric Health Care.
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