Vicks Nyquil Vapocool Severe

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, 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. For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours, not to exceed 8 caplets 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:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. Additionally, this product should not be used for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to use.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen. Healthcare professionals should advise patients to adhere strictly to the following guidelines to mitigate risks:

• Do not exceed 8 caplets in a 24-hour period, which is the maximum daily dosage.

• Avoid concurrent use with other medications containing acetaminophen.

• Refrain from consuming 3 or more alcoholic drinks daily 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 occur, 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 advised to consult a physician promptly.

General precautions are essential for safe use of this product. Patients should not use it 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 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 using this product, 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 that produces excessive phlegm

• Breathing problems or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema

• Difficulty urinating due to an enlarged prostate gland

Patients should also seek advice from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

While using this product, patients must adhere to the recommended dosage and be aware of potential side effects, including excitability, particularly in children, and marked drowsiness. It is advisable to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, given that alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and consult a healthcare professional if they experience any of the following:

• Nervousness, dizziness, or sleeplessness

• Worsening pain, nasal congestion, or cough lasting more than 7 days

• Fever that worsens or persists beyond 3 days

• Presence of redness or swelling

• Onset of new symptoms

• Recurrence of cough accompanied by rash or headache lasting longer than expected

These symptoms may indicate a serious condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 8 caplets within 24 hours, use this product in conjunction with other drugs containing acetaminophen, or consume 3 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.

A sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease should avoid this product during treatment and for 2 weeks after discontinuation of the MAOI. If there is uncertainty regarding the presence of acetaminophen or an MAOI in a prescription drug, patients are advised to consult a doctor or pharmacist.

Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or those experiencing a cough with excessive phlegm should seek medical advice before using this product. Additionally, individuals with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema, as well as those having difficulty urinating due to an enlarged prostate gland, should also consult a healthcare professional 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 should adhere strictly to the recommended dosage. Excitability may occur, particularly in children, and marked drowsiness is a potential side effect. Alcoholic beverages should be avoided, and caution is advised when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients are advised to discontinue use and consult a doctor 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 arise; or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition.

In the event of an overdose, it is critical to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Vicks Nyquil Vapocool Severe (acetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide). 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 not recommended for children under 4 years of age. For adults and children aged 12 years and older, the recommended dosage is 2 caplets with water every 4 hours, with a maximum of 8 caplets in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. It is essential to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Quick medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

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, 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 currently no available data on 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

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 8 caplets within a 24-hour period. Additionally, the risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is recommended 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 acetaminophen use in the context of their liver function. Monitoring of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

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 adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. 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 stopped taking an MAOI 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 stop using the product and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be advised to discontinue use 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 with 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 may also be a side effect. Patients should be advised to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution should be exercised when driving a motor vehicle or operating machinery.

Patients should be encouraged 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, glaucoma, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema. Additionally, patients who have difficulty urinating due to an enlarged prostate gland should seek medical advice before use. It is also recommended that patients consult a doctor or pharmacist if they are taking sedatives or tranquilizers, or if they are using 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 25ºC to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.

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

View product document (PDF)