Nyquil Severe Plus Vapocool Cold and Flu, Nyquil Severe Plus Vapocool Cold an...

Description

NyQuil™ SEVERE+ is a combination medication formulated to provide nighttime relief from cold and flu symptoms. It contains four active ingredients: Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, and Dextromethorphan HBr. The product is presented in the form of four coated caplets, designed for ease of swallowing. NyQuil™ SEVERE+ is marketed under the VICKS® VapoCOOL™ brand and is distributed by Lil' DrugStore®.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, and cough that may interfere with sleep. Additionally, it provides relief from minor aches and pains, headache, fever, sore throat, runny nose, and sneezing.

The formulation also 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 in 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, 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.

• 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. This includes a prohibition on use for 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription drug contains an MAOI, a healthcare professional should be consulted prior to use.

• Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 caplets within a 24-hour period, using concurrently with other medications containing acetaminophen, or consuming 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. Additionally, if a sore throat is severe, persists beyond 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

General precautions should be observed when using this product. It is contraindicated to use this medication in conjunction 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 recommended.

This product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt regarding the presence of an MAOI in a prescription, a healthcare provider should be consulted prior to use.

Healthcare professionals should advise patients to seek medical guidance 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, individuals experiencing difficulty urinating due to an enlarged prostate gland should consult a healthcare provider.

Patients taking sedatives, tranquilizers, or the anticoagulant warfarin should also seek advice from a healthcare professional before using this product.

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

Patients are advised to discontinue use and consult a healthcare provider 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 or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 8 caplets 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 in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Additionally, it is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients uncertain about the presence of an MAOI in their prescription should consult a doctor or pharmacist.

Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, chronic cough with excessive phlegm, or breathing problems such as asthma, chronic bronchitis, or emphysema should seek medical advice before using this product. Furthermore, individuals taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also consult a healthcare professional prior to use.

While using this product, patients must adhere strictly 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 and to exercise caution when driving or operating machinery, as 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 arise; 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

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of an MAOI. This interaction may lead to serious adverse effects, including hypertensive crises.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects of the medication, leading to increased drowsiness.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as there may be an increased risk of bleeding or other interactions.

Caution is advised when consuming alcohol, as it may further increase drowsiness when taken in conjunction with this medication, sedatives, or tranquilizers. Monitoring for excessive sedation and other adverse effects is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Nyquil Severe Plus Vapocool Cold and Flu, Nyquil Severe Plus Vapocool Cold and Flu, Cvp Health, Nyquil Severe Plus Vapocool Cold and Flu, Travel Basix (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 medication is not recommended for children under 4 years of age. For dosing, adults and children aged 12 years and older may take 2 caplets with water every 4 hours, with a maximum of 8 caplets in a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness is a potential side effect that may affect children.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this product, particularly if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or respiratory conditions such as asthma, chronic bronchitis, or emphysema. Additionally, those experiencing chronic cough associated with excessive phlegm or who have difficulty urinating due to an enlarged prostate gland should seek medical advice before use.

It is also advisable for geriatric patients to inform their doctor or pharmacist if they are currently taking sedatives, tranquilizers, or anticoagulants such as warfarin, as these medications may interact with the product.

Elderly patients should exercise caution when driving or operating machinery while using this product, as the combined effects of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should discontinue use and consult a healthcare provider if they experience symptoms such as nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or if a cough persists beyond 7 days. Additionally, if fever worsens or lasts more than 3 days, or if new symptoms arise, including cough accompanied by a rash or headache that persists, these may indicate a serious condition requiring medical attention.

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 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 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 patients exceed the maximum daily dosage of 8 caplets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

It is also advised that patients consuming three or more alcoholic drinks daily refrain from using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with known liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

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 effects were reported in studies evaluating the developmental toxicity of the compounds. Additionally, no increase in fetal malformations was observed in animal studies.

Studies in animals have demonstrated that acetaminophen can induce liver damage at high doses. Furthermore, acetaminophen has been linked to adverse developmental outcomes when administered at doses significantly exceeding the recommended human dose.

Doxylamine succinate has been shown to produce sedation in animal models, while phenylephrine hydrochloride has been associated with increased blood pressure in similar studies. Dextromethorphan hydrobromide has been observed to suppress the cough reflex in animal models.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions 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 the medication out of reach of children to prevent accidental ingestion. It is important to emphasize the necessity of seeking immediate medical assistance or contacting a Poison Control Center in the event of an overdose. Patients should be informed that quick medical attention is critical for both adults and children, even if they do not observe any signs or symptoms of overdose. This proactive approach can help ensure safety and effective management in case of an emergency.

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 to maintain its integrity and efficacy. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should be observed to prevent any compromise to the product's quality during storage and transportation.

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, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately. Quick medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Nyquil Severe Plus Vapocool Cold and Flu, Nyquil Severe Plus Vapocool Cold and Flu, Cvp Health, Nyquil Severe Plus Vapocool Cold and Flu, Travel Basix, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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