Vicks Nyquil

Description

VICKS® NyQuil™ COLD & FLU is a combination medication formulated to provide nighttime relief from cold and flu symptoms. The active ingredients include acetaminophen, which serves as a pain reliever and fever reducer; doxylamine succinate, an antihistamine; and dextromethorphan HBr, a cough suppressant. This product contains 10% alcohol and is available in a liquid dosage form, with a total volume of 4 fluid ounces (118 mL).

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: cough due to minor throat and bronchial irritation, cough to facilitate sleep, sore throat, headache, minor aches and pains, fever, and runny nose with sneezing.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take the medication only as directed. The provided dose cup must be used for accurate measurement.

For adults and children aged 12 years and older, the recommended dosage is 30 mL per dose, administered every 6 hours. It is important not to exceed 4 doses within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a healthcare professional 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) for depression, psychiatric or emotional conditions, or Parkinson's disease, or within 2 weeks of discontinuing such treatment. The interaction between this product and MAOIs may lead to serious adverse effects. 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 minimize the risk of liver injury: do not exceed 4 doses (30 mL each) 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 advised to consult a physician promptly.

General precautions should be emphasized to patients. They should not use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be encouraged 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 advised to confirm with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should seek medical advice prior to using this product if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing difficulties due to chronic conditions such as asthma or emphysema, or urinary issues related to an enlarged prostate gland. Furthermore, individuals taking sedatives, tranquilizers, or the anticoagulant warfarin should consult a healthcare professional before use.

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 essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact their healthcare provider if any of the following occur: worsening pain or cough lasting more than 7 days, fever that worsens or persists beyond 3 days, the presence of redness or swelling, the emergence of new symptoms, or a recurrence of cough accompanied by rash or headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 4 doses (30 mL each) within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may 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 where a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

While using this product, excitability may occur, particularly in children, and marked drowsiness is also a possibility. Patients are cautioned to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, given that alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts longer than 7 days, if fever worsens or persists beyond 3 days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms could indicate a serious condition requiring medical evaluation.

Drug Interactions

Concurrent use of this medication with any other drug 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 two weeks following the discontinuation of an MAOI. This interaction may lead to serious and potentially life-threatening side effects.

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 adverse effects.

It is important to note that the concomitant use of alcohol, sedatives, and tranquilizers with this medication may further increase drowsiness, necessitating caution in activities requiring alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Vicks Nyquil (acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate). 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 using this product. It is contraindicated in children under 4 years of age. Caution is advised as excitability may occur, particularly in pediatric patients.

Geriatric Use

There is no specific information 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or 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

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 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 (30 mL each) 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 with compromised liver function refrain from consuming 3 or more alcoholic drinks daily while using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with a history of liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular 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, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No teratogenic effects have been observed in nonclinical studies. Additionally, there are no reported non-teratogenic effects. The available data does not provide any details regarding nonclinical toxicology. Furthermore, there are no findings related to 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 and seek medical assistance immediately.

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 a medication. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to discontinue use and seek medical advice if their pain or cough worsens or persists for more than seven days, if their fever worsens or lasts more than three days, or if they notice any redness or swelling. They should also be advised to stop use and consult a doctor if new symptoms arise or if a cough returns, particularly if accompanied by a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, especially in children, and that marked drowsiness may also be a side effect. They should be cautioned against consuming alcoholic beverages while using this product, as well as being careful when driving or operating machinery due to the potential for increased drowsiness, especially when combined with alcohol, sedatives, or tranquilizers.

Patients should be encouraged to consult a doctor before using this product if they have liver disease, glaucoma, a cough that produces excessive phlegm, or any breathing problems, including chronic coughs associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use. Finally, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also 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 (77°F). 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)