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

The medication should be taken only as directed. For adults and children aged 12 years and older, the recommended dosage is 2 LiquiCaps taken with water every 4 hours, not to exceed 8 LiquiCaps 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 use of this medication is not recommended for 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.

• 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 typically 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 that the risk of liver injury increases significantly if they exceed the maximum daily dosage of 8 Liquicaps within a 24-hour period. Additionally, patients should be cautioned against concurrent use with other medications containing acetaminophen and the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of any skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay.

Patients should be instructed to stop use and seek medical advice if any of the following occur: pain or cough worsens or lasts longer than 7 days; fever worsens or persists for more than 3 days; redness or swelling develops; new symptoms arise; 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 further evaluation.

Healthcare professionals should remain vigilant for these warnings and ensure appropriate monitoring and intervention as necessary.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed the maximum daily dosage of 8 Liquicaps within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical consultation.

It is recommended that patients stop using the product and consult a doctor if pain or cough worsens or lasts longer than seven days, if fever worsens or persists for more than three days, if redness or swelling is present, if new symptoms arise, or if a cough recurs with a rash or headache that lasts.

Patients with certain pre-existing conditions should consult a doctor before using this product. These conditions include liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema, and difficulty urinating due to an enlarged prostate gland.

Furthermore, patients should seek advice from a doctor or pharmacist if they are currently taking sedatives or tranquilizers, or if they are using the blood-thinning medication warfarin.

Drug Interactions

Acetaminophen has the potential to significantly elevate the risk of severe liver damage when used concurrently with other acetaminophen-containing products or in individuals consuming three or more alcoholic beverages daily.

Doxylamine succinate may lead to pronounced drowsiness, particularly when combined with alcohol, sedatives, or tranquilizers, thereby heightening the risk of sedation.

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. It is advised that this product not be administered for at least two weeks following the discontinuation of an MAOI.

Warfarin, an anticoagulant, may exhibit enhanced effects when taken alongside this product, which necessitates careful monitoring of International Normalized Ratio (INR) levels to ensure patient safety.

No additional drug interactions or drug and laboratory test interactions have been identified.

Packaging & NDC

Below are the non-prescription pack sizes of Vicks Nyquil (acetaminophen, dextromethorphan hbr, 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 use. The medication is not recommended for children under 4 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is 2 LiquiCaps with water every 4 hours.

Caution is advised as excitability may occur, particularly in pediatric patients.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for patients to adhere to the following guidelines to minimize the risk of hepatic injury.

The maximum recommended dosage for this product is 8 Liquicaps in a 24-hour period. Patients with compromised liver function should not exceed this limit, as doing so may significantly increase the risk of severe liver damage. Additionally, patients should avoid concomitant use of other medications that contain acetaminophen, as this can further elevate the risk of hepatotoxicity.

Furthermore, patients are advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product. Regular monitoring of liver function may be warranted in patients with existing liver conditions or those who are at increased risk for hepatic impairment. It is essential for patients to consult with their healthcare provider for personalized recommendations and to discuss any concerns regarding liver health while using this product.

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, it is essential to monitor the patient closely and provide supportive care as necessary.

Management of an overdose may involve symptomatic treatment and monitoring of vital signs, as well as specific interventions based on the substance involved. It is recommended that healthcare providers follow established protocols for overdose management and consult relevant guidelines to ensure comprehensive care.

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 indicated that the use of this product may be associated with severe skin reactions. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the product be discontinued immediately and medical assistance be sought.

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 who are unsure if their prescription medication contains an MAOI should seek guidance from a healthcare professional.

Patients should be advised 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 instructed to seek medical advice 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 must be cautioned not to exceed the recommended dosage. They should be made aware that excitability may occur, especially in children, and that marked drowsiness is a possible side effect. Patients should avoid consuming alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Additionally, patients should exercise caution when driving or operating machinery.

Patients with liver disease, glaucoma, a cough that produces excessive phlegm, or breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema should be advised to consult a doctor before using this product. Those experiencing difficulty urinating due to an enlarged prostate gland, as well as patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should also seek advice from a healthcare professional prior to 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 25° C to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance and safety.

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

View product document (PDF)