Vicks Nyquil

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 alleviates cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and 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 every 6 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:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

• The product should not be used 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 minimize the risk of liver injury: 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 lead to severe skin reactions. Symptoms such as skin reddening, blisters, or rash may indicate an allergic reaction. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding the potential for severe sore throat symptoms. If a patient experiences a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt medical evaluation is warranted.

General precautions must be communicated to patients. They should be advised against using this product in conjunction with any other medications containing acetaminophen, whether prescription or over-the-counter. 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 medications.

Patients with specific medical conditions should seek medical advice prior to use. These conditions include liver disease, glaucoma, excessive mucus production with cough, chronic respiratory issues (such as asthma, chronic bronchitis, or emphysema), and urinary difficulties due to an enlarged prostate gland. Furthermore, individuals taking sedatives, tranquilizers, or the anticoagulant warfarin should consult a healthcare professional before using this product.

In cases of overdose, immediate medical attention is critical. Patients should be instructed to 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 should also be advised to discontinue use and consult a 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 lasting for an extended period. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4 doses in 24 hours, use it in conjunction with other drugs 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.

Additional adverse reactions that may occur during the use of this product include excitability, particularly in children, and marked drowsiness. Patients are cautioned to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Care should be taken when driving a motor vehicle or operating machinery due to the potential for impaired alertness.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts longer than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 under 4 years of age should not use this medication. For children aged 4 to under 12 years, it is advised to consult a doctor before use. The recommended dosage for adults and children 12 years and older is 30 mL every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children, and marked drowsiness is a potential side effect. It is essential to keep this medication out of reach of children. Quick medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients may not have specific geriatric use information available in the prescribing information. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for this population. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential age-related physiological changes. Monitoring for efficacy and safety is advised, as with any medication prescribed to elderly individuals.

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 the safety of both the mother and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a healthcare 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 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.

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 amount of 4 doses 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 3 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 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 health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability has been observed, particularly in pediatric populations. Additionally, marked drowsiness may occur, which can be exacerbated by the concurrent use of alcohol, sedatives, and tranquilizers.

No information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Furthermore, there is no data provided on animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include skin reddening, blisters, and rash. In cases where a skin reaction occurs, it is advised that users discontinue use and seek medical assistance promptly.

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 past two weeks. Patients who are unsure if their prescription medication contains an MAOI should be advised to seek clarification from a healthcare professional.

Patients should be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists for more than 7 days, if their fever worsens or lasts more than 3 days, or if they notice any redness or swelling. They should also be advised to seek medical attention 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 is a possible 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. Additionally, patients should be informed that the use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients with liver disease, glaucoma, or a cough associated with excessive phlegm should be advised to consult a doctor before using this product. Those with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use. Furthermore, patients experiencing difficulty urinating due to an enlarged prostate gland should consult a healthcare professional before using this medication. Lastly, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should be encouraged to discuss their current medications with a doctor or pharmacist before use.

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. 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 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 medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

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)