Vicks Nyquil Severe Honey

Description

No description information is available.

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 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.

The medication is not recommended for children aged 4 to under 6 years unless specifically directed by a healthcare professional. Additionally, it is contraindicated for use in 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. 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) for depression, psychiatric or emotional conditions, or Parkinson's disease, or within 2 weeks of discontinuing such treatment. If there is uncertainty about the presence of an MAOI in a prescription drug, a healthcare professional should be consulted prior to use.

• For the purpose of inducing sleepiness in children.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

General precautions must be observed to ensure safe administration. It is imperative that this medication is not used concurrently with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare provider or pharmacist is advised.

This medication should not be administered to individuals 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 used for at least two weeks following the discontinuation of an MAOI. If there is any doubt about whether a prescription drug contains an MAOI, it is essential to seek guidance from a healthcare provider or pharmacist prior to use.

This medication is not intended to induce sleepiness in children and should not be used for that purpose.

Healthcare professionals should instruct patients to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Furthermore, patients should be advised to stop taking the medication and seek medical advice if pain, nasal congestion, or cough worsens or persists beyond five days in children or seven days in adults. If fever intensifies or lasts more than three days, or if any redness or swelling occurs, patients should also be directed to stop use and contact their healthcare provider. New or unusual symptoms that arise during treatment warrant immediate consultation with a doctor. Additionally, if a cough recurs or is accompanied by a rash or persistent headache, these may indicate a serious condition, and medical attention should be sought promptly.

Side Effects

Patients may experience a range of adverse reactions while using this medication, which can vary in seriousness and frequency.

Serious adverse reactions may include symptoms indicative of a serious condition. Patients are advised to discontinue use 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 recurrence of cough accompanied by a rash or headache that lasts warrants immediate consultation with a healthcare provider.

Common adverse reactions may also arise, particularly in patients with pre-existing conditions. It is recommended that individuals with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or chronic respiratory issues, such as asthma or chronic bronchitis, consult a healthcare professional prior to use. Furthermore, patients experiencing trouble urinating due to an enlarged prostate gland should seek medical advice before starting the medication.

Patients currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin are advised to consult with a doctor or pharmacist before using this product to avoid potential interactions.

Drug Interactions

Acetaminophen has the potential to increase the risk of liver damage when used concurrently with other acetaminophen-containing medications or in patients who consume three or more alcoholic beverages daily. Caution is advised in these situations to mitigate the risk of hepatotoxicity.

Dextromethorphan should not be administered in conjunction with monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing an MAOI due to the risk of severe interactions, which may lead to serious adverse effects.

The anticoagulant effects of warfarin may be influenced by the concomitant use of acetaminophen. Therefore, it is recommended that International Normalized Ratio (INR) levels be closely monitored to ensure therapeutic efficacy and safety.

Additionally, the use of alcohol, sedatives, and tranquilizers in combination with this product may enhance drowsiness. Patients should exercise caution when engaging in activities that require full alertness, such as driving or operating machinery.

Packaging & NDC

Below are the non-prescription pack sizes of Vicks Nyquil Severe Honey (acetaminophen, dextromethrophan, doxylamine succinate, 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, use is not recommended unless directed by a healthcare professional. The medication is contraindicated in children under 4 years of age.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness is a potential side effect. If pain, nasal congestion, or cough worsens or persists for more than 5 days in children, medical evaluation is advised.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is essential. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially 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 potential 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 safe use during pregnancy and lactation.

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 specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients 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 have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for guidance on specific management protocols.

In summary, while no specific overdosage information is available, healthcare professionals should exercise caution and be prepared to respond to potential overdose situations with appropriate clinical interventions.

Nonclinical Toxicology

No data is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The nonclinical toxicology section lacks any relevant data. Furthermore, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has reported adverse reactions associated with the use of acetaminophen. Notable among these are severe skin reactions, which include symptoms such as skin reddening, blisters, and rash. These events have been documented through voluntary reports and surveillance programs.

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 this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such 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.

Patients should be made aware that new symptoms may arise, and they should stop use and consult a doctor if a cough returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition. It is essential to emphasize that patients should not exceed the recommended dosage.

When using this product, patients may experience excitability, particularly in children, and marked drowsiness may occur. Patients should be advised to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should be exercised when driving or operating machinery.

Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or those experiencing a cough with excessive phlegm should be advised to consult a doctor before using this product. Additionally, patients with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use. Those who have difficulty urinating due to an enlarged prostate gland, as well as individuals taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should also consult a healthcare provider 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 25º 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 healthcare 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 Nyquil Severe Honey, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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