Vicks Dayquil

Description

VICKS® DayQuil™ INTENSE FLU is a multi-symptom formulation designed to provide daytime relief from various flu-related symptoms. This product contains acetaminophen, which serves as a pain reliever and fever reducer, and dextromethorphan HBr, functioning as a cough suppressant. It is indicated for alleviating body aches, fever, headache, sore throat, and cough. The new formula includes 10% alcohol and is available in a liquid dosage form, with a total volume of 12 fluid ounces (354 mL).

Uses and Indications

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

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

Dosage and Administration

Patients should take the medication only as directed and utilize the dose cup provided for accurate measurement.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours, with a maximum of 3 doses (totaling 90 mL) within a 24-hour period.

For children aged 4 to under 6 years, it is advised to consult a physician for appropriate dosing recommendations. The medication is not indicated for use in 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. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

• The product should not be used in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease, nor within 2 weeks of discontinuing an MAOI. If there is uncertainty about whether a prescription drug contains an MAOI, a healthcare professional should be consulted prior to use.

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 recommended dosage guidelines. Specifically, patients should not exceed three doses (30 mL each) within a 24-hour period, as this represents the maximum daily amount. Additionally, caution is warranted when this product is used in conjunction with other medications containing acetaminophen, as this can further increase the risk of liver damage. Patients should also be advised against the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative that patients consult a healthcare provider without delay.

Patients should be instructed to stop use and seek medical advice if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or persists beyond three days; redness or swelling develops; 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 that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 3 doses (30 mL each) within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, if a patient experiences a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

In cases of overdose, it is crucial for patients to seek medical help or contact a Poison Control Center without delay, as timely medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patients are advised to stop use and consult a doctor if any of the following occur: pain or cough worsens or lasts more than 7 days; fever worsens or lasts more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be administered for at least two weeks following the discontinuation of an MAOI to avoid potential hypertensive crises or other serious adverse effects.

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safe and effective use, as interactions could potentially alter the anticoagulant effect of warfarin.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 4 to under 6 years should consult a healthcare professional before use. The medication is not recommended for children under 4 years of age. For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours, with a maximum of 3 doses within 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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

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

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 3 doses (30 mL each) within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this may further increase the risk of liver injury.

It is also important for patients with compromised liver function to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product is contraindicated, as it may exacerbate the potential for liver damage.

Monitoring of liver function is recommended for patients with hepatic impairment who are prescribed this product, particularly if they are at increased risk for liver-related adverse effects. Regular assessment of liver enzymes may be warranted to ensure patient safety and to mitigate the risk of severe hepatic injury.

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 are advised to remain vigilant and proactive in managing potential overdose situations. The lack of immediate symptoms does not preclude the possibility of serious health consequences, and therefore, timely evaluation and treatment are essential.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed 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 crucial to inform patients that they should not use this medication 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 or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if their pain or cough worsens or persists for more than 7 days. Additionally, they should stop using the medication and consult a doctor if their fever worsens or lasts longer than 3 days, if they experience redness or swelling, or if new symptoms arise. Patients should also be made aware that if their cough returns or occurs alongside a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition.

Before using this medication, patients with liver disease should be advised to consult their healthcare provider. Furthermore, patients should be encouraged to ask a doctor before use if they have a cough accompanied by excessive phlegm, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Lastly, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist prior to 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 (77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure the product's efficacy 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 immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

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

View product document (PDF)