Vicks Dayquil Severe Honey

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, 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

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that adults must not exceed 4 doses (30 mL each) within a 24-hour period, and children must not exceed 4 doses (15 mL each) in the same timeframe. Caution is particularly warranted if the product is taken concurrently with other medications containing acetaminophen or if the adult consumes 3 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. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

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 should be advised to consult a healthcare provider promptly.

Patients should also be instructed to stop use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts beyond 5 days in children or 7 days in adults, or if fever worsens or persists for more than 3 days, medical consultation is necessary. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache that lasts should also prompt immediate medical evaluation, as these may indicate a serious condition.

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 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. 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 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 is accompanied by a rash or headache that persists may indicate a serious condition, warranting immediate medical evaluation.

Drug Interactions

Patients taking acetaminophen should consult with a healthcare professional prior to use if they are concurrently using warfarin, a blood-thinning medication. The interaction between acetaminophen and warfarin may necessitate careful monitoring of INR levels to ensure safe and effective anticoagulation therapy.

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

Packaging & NDC

Below are the non-prescription pack sizes of Vicks Dayquil Severe Honey (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). 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. For children aged 4 to under 6 years, it is advised to consult a healthcare professional before use. The product is not recommended for children under 4 years of age.

Healthcare professionals should be aware of the liver warning associated with this medication. If a child exceeds 4 doses of 15 mL within a 24-hour period, which is the maximum daily amount, there may be a risk of liver damage.

Geriatric Use

There is no specific information available 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. 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 medication in human 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 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 hepatotoxicity. Adjustments to dosing or alternative therapies should be considered in these patients to mitigate the risk of severe liver injury.

Overdosage

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

Risk of Severe Liver Damage Severe liver damage may occur in adults who exceed the maximum daily dosage of 4 doses (30 mL each) within a 24-hour period. Similarly, children are at risk if they consume more than 4 doses (15 mL each) in the same timeframe. It is crucial for healthcare professionals to monitor patients for signs of liver impairment, particularly in those who may have inadvertently exceeded these limits.

Drug Interactions The risk of severe liver damage is further heightened when this product is taken concurrently with other medications containing acetaminophen. Healthcare providers should be vigilant in assessing a patient's medication history to prevent potential interactions that could exacerbate liver toxicity.

Alcohol Consumption Adults who consume 3 or more alcoholic drinks daily while using this product are also at an increased risk of severe liver damage. It is advisable for healthcare professionals to counsel patients on the dangers of combining alcohol with this medication, emphasizing the importance of adhering to recommended guidelines.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare professionals should initiate appropriate management procedures, which may include monitoring liver function tests and providing supportive care as necessary. Prompt intervention is essential to mitigate the risk of long-term hepatic injury.

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 indicated that acetaminophen may be associated with severe skin reactions. These reactions can manifest as symptoms including skin reddening, blisters, and rash. In the event of a skin reaction, it is recommended that the use of acetaminophen 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 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 past two weeks. Patients who are unsure if their prescription medication contains an MAOI should be advised to seek clarification from a healthcare professional.

Patients should be instructed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop use and seek medical advice 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 stop use and contact a healthcare provider. New symptoms that arise during treatment should prompt patients to seek medical advice.

Patients should be cautioned against exceeding the recommended dosage. It is essential for patients to consult a doctor before using this product 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 accompanied by excessive phlegm or if they have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should be encouraged to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It is essential to store the product at a temperature not exceeding 25°C. Refrigeration is not recommended. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)