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Vicks Dayquil Severe

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Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
February 5, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
February 5, 2026
Manufacturer
The Procter & Gamble Manufacturing Company
Registration number
M012
NDC root
37000-517
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

VICKS DayQuil SEVERE COLD & FLU is a medication designed to provide temporary relief from various symptoms associated with the common cold and flu. It contains a combination of ingredients, including acetaminophen (which helps reduce fever and relieve minor aches and pains), guaifenesin (which helps loosen mucus and make coughs more productive), phenylephrine HCl (which relieves nasal and sinus congestion), and dextromethorphan HBr (which helps suppress cough).

This non-drowsy formulation is available in convenient LiquiCaps™ and works to alleviate symptoms such as nasal congestion, sinus pressure, sore throat, headache, and cough, while also promoting easier breathing and reducing swelling in the nasal passages.

Uses

This medication is designed to temporarily relieve a variety of common cold and flu symptoms. If you're dealing with nasal or sinus congestion and pressure, this product can help reduce swelling in your nasal passages, making it easier for you to breathe. It also addresses minor aches and pains, headaches, fever, and sore throats.

In addition to easing these discomforts, it promotes drainage in your nasal and sinus areas and helps loosen phlegm (mucus). This can make your coughs more productive by clearing out bothersome mucus from your bronchial passageways. Overall, this medication aims to provide you with relief so you can feel more comfortable while you recover.

Dosage and Administration

It's important to take this medication exactly as directed. For adults and children aged 12 years and older, you should take 2 LiquiCaps with water every 4 hours, but make sure not to exceed 8 LiquiCaps in a 24-hour period.

If you have children between the ages of 4 and under 12 years, it's best to consult a doctor before giving them this medication. For children under 4 years old, do not use this product at all. Always follow these guidelines to ensure safe and effective use.

What to Avoid

You should avoid using this product if you are currently taking any other medication that contains acetaminophen, whether it's a prescription or over-the-counter drug. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, or for two weeks after stopping an MAOI. Again, if you're uncertain about your medications, it's best to ask a healthcare professional.

It's also important to follow the dosing instructions carefully and not exceed the recommended amount when using this product. Taking more than directed can lead to serious health risks. Always prioritize your safety by checking with a healthcare provider if you have any questions or concerns.

Side Effects

You should be aware that this product contains acetaminophen, which can lead to severe liver damage if you exceed the maximum daily limit of 8 LiquiCaps, take it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Additionally, acetaminophen may cause serious skin reactions, including skin reddening, blisters, or rashes. If you notice any of these symptoms, stop using the product and seek medical help immediately.

It's important to stop using this product and consult a doctor if you experience nervousness, dizziness, or sleeplessness, if your pain, nasal congestion, or cough worsens or lasts more than 7 days, if your fever worsens or lasts more than 3 days, or if you notice redness or swelling. New symptoms or a cough that returns with a rash or headache that lasts could indicate a serious condition, so please take these signs seriously.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 8 LiquiCaps in 24 hours, use it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you experience any skin reaction, stop using the product and seek medical help immediately. If you have a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

Before using this product, check with your doctor if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate. It's also important to avoid using this product with any other medications containing acetaminophen or if you are currently taking a monoamine oxidase inhibitor (MAOI) or have taken one in the last two weeks. If you are on the blood thinner warfarin, consult your doctor or pharmacist before use. Always follow the dosage instructions carefully.

If you suspect an overdose, seek medical help or contact a Poison Control Center immediately, as quick attention is crucial. Stop using the product and call your doctor if you feel nervous, dizzy, or sleepless, if your pain or cough worsens or lasts more than 7 days, if your fever worsens or lasts more than 3 days, or if you notice any new symptoms. These could indicate a more serious condition.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. Quick action is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for your child, it's important to know the guidelines for different age groups. For children aged 4 to under 12 years, you should consult a doctor before using it. However, if your child is under 4 years old, do not use this medication at all.

For adults and children aged 12 years and older, the recommended dosage is 2 LiquiCaps taken with water every 4 hours, but you should not exceed 8 LiquiCaps in a 24-hour period. Always follow these guidelines to ensure the safety and well-being of your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication, especially if you have difficulty urinating due to an enlarged prostate gland. Additionally, if you are taking the blood thinner warfarin, make sure to discuss this with your doctor or pharmacist before starting the medication. They can provide guidance on any necessary adjustments or monitoring to ensure your safety and well-being.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, which contains acetaminophen. To avoid severe liver damage, do not take more than 8 LiquiCaps in a 24-hour period, and be careful not to combine it with other medications that also contain acetaminophen. Additionally, limit your alcohol intake to fewer than 3 drinks per day while using this product, as drinking more can increase the risk of liver damage.

Before using this product, please consult your doctor if you have liver disease. They can provide guidance tailored to your specific health needs and help ensure your safety while using this medication.

Drug Interactions

It's important to be cautious when taking medications. If you are using any other products that contain acetaminophen (a common pain reliever), you should avoid combining them with this medication, as doing so can lead to serious liver damage.

Additionally, if you are taking warfarin, a medication that helps prevent blood clots, you should consult your healthcare provider before using this drug. Combining these medications may increase your risk of bleeding. Always discuss your current medications and any tests with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature not exceeding 25ºC (77ºF). This helps maintain its quality and performance. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage.

If you have any components that come with the product, make sure to keep them in their designated storage conditions as well. Proper disposal of any used materials should also be followed according to local guidelines to ensure safety and environmental responsibility.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Always keep this medication out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center immediately, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

FAQ

What is VICKS DayQuil SEVERE COLD & FLU used for?

VICKS DayQuil SEVERE COLD & FLU is used to temporarily relieve symptoms associated with the common cold and flu, including nasal congestion, cough, minor aches and pains, headache, fever, and sore throat.

What are the active ingredients in VICKS DayQuil SEVERE COLD & FLU?

The active ingredients are Acetaminophen, Guaifenesin, Phenylephrine HCl, and Dextromethorphan HBr.

How should I take VICKS DayQuil SEVERE COLD & FLU?

Adults and children 12 years and over should take 2 LiquiCaps with water every 4 hours, not exceeding 8 LiquiCaps in 24 hours.

Are there any contraindications for using VICKS DayQuil SEVERE COLD & FLU?

Do not use this product with any other drug containing acetaminophen or if you are taking a prescription monoamine oxidase inhibitor (MAOI).

What should I do if I experience severe skin reactions?

If you notice symptoms like skin reddening, blisters, or rash, stop using the product and seek medical help immediately.

What are the liver warnings associated with VICKS DayQuil SEVERE COLD & FLU?

Severe liver damage may occur if you take more than 8 LiquiCaps in 24 hours, use with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

Can I use VICKS DayQuil SEVERE COLD & FLU if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this product.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away, as quick medical attention is critical.

What are the storage instructions for VICKS DayQuil SEVERE COLD & FLU?

Store the product at no greater than 25ºC.

Packaging Info

Below are the non-prescription pack sizes of Vicks Dayquil Severe (acetaminophen, phenylephine hcl, dextromethorphan hydrobromide, and guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Vicks Dayquil Severe.
Details

Drug Information (PDF)

This file contains official product information for Vicks Dayquil Severe, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it addresses the following symptoms: nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, minor aches and pains, headache, fever, and sore throat.

Additionally, this drug reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, promotes nasal and/or sinus drainage, and helps loosen phlegm (mucus) and thin bronchial secretions. This action aids in clearing the bronchial passageways of bothersome mucus, thereby making coughs more productive.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take the medication only as directed. The recommended dosage for adults and children aged 12 years and older is 2 LiquiCaps taken with water every 4 hours, not to exceed 8 LiquiCaps in a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The use of this medication is not recommended for children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited. Healthcare professionals should verify the presence of acetaminophen in other medications if there is uncertainty.

  • The product should not be used in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Consultation with a healthcare professional is advised if there is uncertainty regarding the presence of an MAOI in a patient's medication regimen.

  • Additionally, it is essential to adhere to the recommended dosage and not exceed the directed use of this product.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the maximum daily dosage of 8 LiquiCaps within a 24-hour period. Caution is warranted if patients are concurrently using other medications containing acetaminophen, as this can increase the risk of liver injury. Additionally, patients should be informed that consuming three or more alcoholic drinks daily while using this product may exacerbate the risk of liver damage.

Acetaminophen may also provoke severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

General precautions include the recommendation to avoid the concurrent use of any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a healthcare professional. Furthermore, this product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or for two weeks following the cessation of such medications. Patients should be advised to confirm with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Healthcare professionals should recommend that patients consult a doctor prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Patients with persistent or chronic coughs, such as those related to smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice before using this product. Additionally, patients taking the anticoagulant warfarin should consult a healthcare professional before use.

Patients must be cautioned against exceeding the directed dosage when using this product. In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center is advised, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition requiring medical evaluation.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health and allergic responses.

Severe liver damage may occur if patients exceed the maximum recommended dosage of 8 LiquiCaps in a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be instructed to stop use and consult a healthcare professional if they experience symptoms such as nervousness, dizziness, or sleeplessness. Other concerning signs include worsening pain, nasal congestion, or cough lasting more than 7 days, fever that worsens or persists beyond 3 days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen is contraindicated due to the potential for severe liver damage.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. The combination may elevate the risk of bleeding. It is recommended that patients consult a healthcare professional prior to using this medication if they are currently taking warfarin. Monitoring of coagulation parameters may be warranted to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of Vicks Dayquil Severe (acetaminophen, phenylephine hcl, dextromethorphan hydrobromide, and guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Vicks Dayquil Severe.
Details

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is not recommended for children under 4 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is 2 LiquiCaps taken with water every 4 hours, with a maximum of 8 LiquiCaps in a 24-hour period.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. Additionally, it is advisable for patients taking the anticoagulant warfarin to seek guidance from a doctor or pharmacist before initiating treatment. Monitoring and appropriate dosing adjustments may be necessary to ensure safety and efficacy in this population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 8 LiquiCaps within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

It is also advised that patients with compromised liver function refrain from consuming 3 or more alcoholic drinks daily while using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with a history of liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide comprehensive care as needed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with acetaminophen. Reported symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the last two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and consult a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. Patients should also be informed to seek medical attention if new symptoms arise or if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical advice if they have a cough that produces excessive phlegm or if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Lastly, patients taking the blood-thinning medication warfarin should be instructed to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature not exceeding 25ºC to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Vicks Dayquil Severe, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Vicks Dayquil Severe, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.