Vicks Dayquil Severe Honey Flavor

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 to 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 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 4 hours, with a maximum of 4 doses within a 24-hour period.

For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours, also not to exceed 4 doses in a 24-hour period.

For children aged 4 to under 6 years, it is advised to consult a physician for appropriate dosing.

The medication is not recommended 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 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.

Additionally, this 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 commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage 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.

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 promptly if a sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions include avoiding the use of this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be encouraged to consult a doctor or pharmacist. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Patients should verify with a healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to stop taking the product and contact their doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that persists, as these may indicate a serious condition.

In cases of severe skin reactions, patients must stop using the product and seek emergency medical help immediately.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of this product. Specifically, adults should not take more than 4 doses (30 mL each) within a 24-hour period, while children should not exceed 4 doses (15 mL each) in the same timeframe. The risk of liver damage is further heightened if the product is taken in conjunction with other medications containing acetaminophen or if the 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. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should also discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts longer than 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 or swelling, the emergence of new symptoms, or a cough that recurs or occurs with a rash or headache that persists may indicate a serious condition, warranting immediate medical evaluation.

Drug Interactions

Patients taking the blood-thinning medication warfarin should consult a healthcare professional prior to using acetaminophen, as there is a potential interaction that may affect anticoagulation control. Monitoring of INR levels may be warranted to ensure therapeutic efficacy and safety when these medications are used concurrently.

No additional drug interactions or laboratory test interactions have been identified for this medication.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may be administered 30 mL every 4 hours. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. In children aged 4 to under 6 years, it is advised to consult a doctor before use. The product is not recommended for children under 4 years of age.

Healthcare professionals should be aware of the liver warning: if a child takes more than 4 doses of 15 mL each within a 24-hour period, this exceeds the maximum daily amount for this product. Parents and caregivers should be instructed to stop use and consult a doctor if a child's pain, nasal congestion, or cough worsens or persists for more than 5 days.

In cases of overdose, quick medical attention is critical for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

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. 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

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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:

• An adult takes more than 4 doses (30 mL each) in a 24-hour period, which is the maximum daily amount for this product.

• A child takes more than 4 doses (15 mL each) in a 24-hour period, which is the maximum daily amount for this product.

• The product is taken concurrently with other medications containing acetaminophen.

• An adult consumes 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver damage, it is recommended that patients with compromised liver function be closely monitored for signs of hepatic toxicity. Adjustments to dosing or additional monitoring may be necessary based on the severity of hepatic impairment and individual patient factors.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Adult Overdosage Risks An adult who ingests more than 4 doses (30 mL each) within a 24-hour period is at risk of experiencing severe liver damage. This threshold represents the maximum daily amount advised for safe use of the product. Additionally, the concomitant use of this product with other medications containing acetaminophen can exacerbate the risk of liver injury.

Pediatric Overdosage Risks For children, the risk of severe liver damage arises if more than 4 doses (15 mL each) are taken within a 24-hour timeframe, which also constitutes the maximum daily dosage for pediatric patients.

Alcohol Consumption Considerations Adults who consume 3 or more alcoholic beverages daily while using this product may further increase their risk of severe liver damage.

Healthcare professionals are advised to monitor patients for symptoms of liver damage, which may include jaundice, abdominal pain, and elevated liver enzymes. In the event of suspected overdosage, immediate medical intervention is recommended to mitigate potential complications.

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

Acetaminophen has been associated with severe skin reactions reported in postmarketing surveillance. Symptoms of these reactions may 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 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 taken one 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 use and consult a doctor if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults. If fever worsens or lasts more than 3 days, or if redness or swelling occurs, patients should also be directed to seek medical attention. New symptoms or a recurrence of cough accompanied by a rash or persistent headache should prompt immediate consultation with a healthcare provider, 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 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. 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

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is crucial 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 essential for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

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

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