Vicks Dayquil Severe Nyquil Severe Honey Flavor

Description

No description information is available for the 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, cough to facilitate sleep, minor aches and pains, headache, fever, sore throat, runny nose, and sneezing.

Additionally, this drug reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, and promotes nasal and/or sinus drainage.

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

Dosage and Administration

Patients should take the medication only as directed, utilizing the dose cup provided to ensure accurate measurement. It is imperative not to exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours.

The use of this medication is not recommended for children aged 4 to under 6 years unless directed by a physician. Additionally, the medication should not be administered to children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

• The product should not be used to induce sleepiness in children.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Healthcare professionals should be aware that the maximum daily dosage for adults is 4 doses (30 mL each) within a 24-hour period, and for children, it is 4 doses (15 mL each) in the same timeframe. Caution is advised if this product is taken concurrently with other medications containing acetaminophen. Additionally, adults consuming 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken for patients with the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or a cough associated with excessive phlegm. Patients with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice before use. Furthermore, individuals experiencing difficulty urinating due to an enlarged prostate gland should consult a healthcare provider prior to use.

Patients should be advised to consult a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

In case of a skin reaction, patients must stop using the product and seek emergency medical help immediately.

Patients should also be instructed to discontinue use and contact a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults, or if fever worsens or lasts more than 3 days, medical advice should be sought. Redness, swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache that lasts are also indicators of potential serious conditions, warranting immediate medical consultation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if the following conditions are met: an adult consumes more than 4 doses (30 mL each) within a 24-hour period, a child exceeds 4 doses (15 mL each) in the same timeframe, the product is taken concurrently with other medications containing acetaminophen, or an adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Participants should stop using the product and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults, or if fever worsens or lasts more than 3 days, medical advice should be sought. 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 longer than expected may indicate a serious condition requiring medical evaluation.

While using this product, patients may experience excitability, particularly in children, and marked drowsiness. Caution is advised when driving or operating machinery. The use of alcoholic beverages, sedatives, and tranquilizers may exacerbate drowsiness.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or chronic respiratory issues (including chronic cough, asthma, chronic bronchitis, or emphysema) should consult a healthcare provider before using this product. Additionally, individuals experiencing difficulty urinating due to an enlarged prostate gland, or those taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should also seek medical advice prior to use.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects. Adjustments to the dosage of either drug may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Vicks Dayquil Severe Nyquil Severe Honey Flavor (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl and doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 15 mL every 4 hours, with a maximum of 4 doses in a 24-hour period. For children aged 4 to under 6 years, use is not recommended unless directed by a healthcare professional. The product is contraindicated in children under 4 years of age.

Healthcare professionals should be aware of a potential liver warning if a child exceeds the maximum daily dosage. Additionally, excitability may occur, particularly in pediatric patients. If symptoms such as pain, nasal congestion, or cough worsen or persist for more than 5 days, it is advised to discontinue use and consult a doctor.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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 important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if the following conditions are met: adults taking more than 4 doses (30 mL each) in a 24-hour period, which is the maximum daily amount for this product; children taking more than 4 doses (15 mL each) in a 24-hour period; or if the product is taken concurrently with other medications containing acetaminophen. Additionally, adults consuming 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

It is advised that patients with liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks associated with their condition. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

Severe liver damage is a significant risk associated with overdosage of this product. In adults, the threshold for potential harm is exceeded when more than four doses (30 mL each) are taken within a 24-hour period, which constitutes the maximum recommended daily amount. Similarly, for children, the risk of severe liver damage arises when more than four doses (15 mL each) are administered in the same timeframe.

To mitigate the risk of accidental ingestion and subsequent overdose, it is imperative to keep this product out of reach of children. This precaution is essential to prevent unintentional exposure and the serious health consequences that may follow.

In the event of suspected overdosage, healthcare professionals should assess the patient's condition and consider appropriate management strategies, which may include monitoring liver function and providing supportive care as necessary.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

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

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 medication contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such a medication. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be cautioned against using this product to induce sleepiness in children. They should be instructed to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the product and consult a doctor if pain, nasal congestion, or cough worsens or persists beyond five days in children or seven days in adults. If fever worsens or lasts more than three days, or if redness or swelling occurs, patients should also seek medical attention. New symptoms or a recurrence of cough, especially if accompanied by a rash or persistent headache, should prompt a consultation with a healthcare provider, as these may indicate a serious condition.

Patients should be reminded to adhere strictly to the recommended dosage and to be aware that excitability may occur, particularly in children. Marked drowsiness is a potential side effect, and patients should be advised to avoid alcoholic beverages while using this product. Caution should be exercised when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Before using this product, patients should be encouraged to consult a doctor if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema. Patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use. Furthermore, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should 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 25°C. Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling should be observed to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

Patients aged 12 years and older are advised to administer 30 mL every 4 hours, while those between 6 to under 12 years should take 15 mL every 4 hours. For children aged 4 to under 6 years, use is not recommended unless directed by a healthcare professional, and it is contraindicated for children under 4 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center, as prompt attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)