Nyquil Vapocool Severe

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 4 to under 12 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:

• 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.

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 following guidelines to mitigate risks: do not exceed 4 doses within a 24-hour period, avoid concurrent use with other medications containing acetaminophen, and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Acetaminophen may also cause severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms arise, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

General precautions must be observed. Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be advised to consult a healthcare professional. 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 be encouraged to verify with their healthcare provider or pharmacist if they are unsure about their prescription drugs.

Before initiating treatment, patients should consult a healthcare professional 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, chronic respiratory issues (such as asthma, chronic bronchitis, or emphysema), difficulty urinating due to an enlarged prostate, or if they are on a sodium-restricted diet. Furthermore, patients should seek advice from a healthcare professional if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a physician if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 7 days; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition requiring medical evaluation.

Side Effects

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

Patients should be aware that acetaminophen may cause 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 and seek medical assistance immediately.

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

This product should not be used concurrently with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should inquire with a doctor or pharmacist if they are uncertain whether a drug contains acetaminophen. Additionally, individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or who have stopped taking an MAOI within the past two weeks should avoid this product.

Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, chronic cough with excessive phlegm, or those experiencing difficulty urinating due to an enlarged prostate gland should consult a doctor before use. Furthermore, individuals on a sodium-restricted diet should also seek medical advice prior to use.

Patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

While using this product, patients must adhere to the recommended dosage. Excitability may occur, particularly in children, and marked drowsiness is a potential side effect. Patients are advised to avoid alcoholic beverages, as well as be cautious when driving or operating machinery, since alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

Acetaminophen has the potential to increase the risk of severe liver damage when used concurrently with other medications containing acetaminophen or when consumed with three or more alcoholic beverages daily. Healthcare professionals should advise patients to avoid combining these substances to mitigate the risk of hepatotoxicity.

Dextromethorphan may interact with monoamine oxidase inhibitors (MAOIs), which can lead to serious adverse effects. It is recommended to avoid the use of dextromethorphan in patients currently taking MAOIs or for a period of two weeks following the discontinuation of MAOIs to prevent potential interactions.

The anticoagulant effect of warfarin may be enhanced when administered alongside acetaminophen. Therefore, it is essential to monitor the International Normalized Ratio (INR) closely in patients receiving this combination to ensure safe and effective anticoagulation management.

Packaging & NDC

Below are the non-prescription pack sizes of Nyquil Vapocool Severe (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is contraindicated in children under 4 years of age. For dosing, adults and children aged 12 years and older are recommended to take 30 mL every 4 hours.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential 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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 patients exceed the maximum daily dosage of 4 doses within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also advised that patients limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as excessive alcohol intake can exacerbate the potential for liver damage.

Patients with known liver disease should consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements.

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 should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which 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 product 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 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 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 using the product and consult a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. Patients should also be informed to seek medical attention if new symptoms arise or if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should be cautioned not to exceed the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery due to the potential for increased drowsiness, especially when combined with alcohol, sedatives, or tranquilizers.

Healthcare providers should recommend that patients 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, glaucoma, a cough associated with excessive phlegm, a chronic cough related to smoking, asthma, chronic bronchitis, emphysema, difficulty urinating due to an enlarged prostate gland, or if they are on a sodium-restricted diet. Furthermore, patients should be advised to speak with a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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

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 Nyquil Vapocool Severe, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)