Night Time Severe Cold and Flu Relief

Description

Night Time Severe Cold & Flu Relief is presented in a dosage form of softgels, with each softgel containing the following active ingredients: Acetaminophen 325 mg, Phenylephrine hydrochloride 5 mg, Doxylamine succinate 6.25 mg, and Dextromethorphan hydrobromide 10 mg. The product is identified by the National Drug Code (NDC) 51013-175-04. This formulation is comparable to the active ingredients found in Vicks® NyQuil® Severe Cold and Flu.

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, adhering to the overdose warning. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every four hours.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing guidance. The medication is not recommended for children under 4 years of age.

When using other nighttime or daytime products, it is essential to carefully read each label to ensure correct dosing and avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated 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 any doubt about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

This product is also contraindicated for use in children for the purpose of inducing sleep.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver damage may occur if they exceed four doses within a 24-hour period, which is the maximum daily amount for this product. Additionally, patients should be cautioned against using this product in conjunction with other medications containing acetaminophen or consuming three or more alcoholic drinks daily while using this product.

In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

Acetaminophen may also lead to severe skin reactions. Symptoms such as skin reddening, blisters, or rash warrant immediate cessation of use and prompt medical attention.

General precautions should be taken for patients with specific health conditions. Healthcare professionals should recommend that patients consult a doctor before using this product if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic cough, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use.

Patients should also be advised to consult a doctor or pharmacist before using this product if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted. Quick medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice 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 develop, or if a cough recurs alongside a rash or headache lasting longer than usual, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of four doses within 24 hours, 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 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.

Participants are advised to consult a healthcare professional if they experience a severe sore throat that persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Patients should discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than seven days; if fever worsens or lasts 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 persists. These symptoms may indicate a serious condition.

While using this product, patients should adhere strictly to the recommended dosage to avoid adverse effects. Notable reactions may include excitability, particularly in children, and marked drowsiness. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution is recommended when driving or operating machinery.

In cases of overdose, which can lead to serious health complications, patients should seek immediate medical attention or contact a Poison Control Center. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

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 2 weeks following the discontinuation of the 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 the combination may enhance sedative effects and increase the risk of 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.

Caution is advised when consuming alcohol, sedatives, or tranquilizers while using this medication, as these substances may potentiate drowsiness and impair cognitive and motor functions. Monitoring for increased sedation and potential impairment is recommended.

Packaging & NDC

Below are the non-prescription pack sizes of Night Time Severe Cold and Flu Relief (acetaminophen, phenylephrine hydrochloride, doxylamine succinate, 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 contraindicated in children under 4 years of age. Caution is advised as excitability may occur, particularly in pediatric patients. Marked drowsiness is also a potential side effect. In the event of an overdose, it is crucial to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent. For patients aged 12 years and older, the recommended dosage is 2 softgels with water every 4 hours.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. 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 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 on 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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. It is critical to adhere to the maximum daily dosage of 4 doses within a 24-hour period, as exceeding this limit may result in severe liver damage.

Additionally, patients must be aware that taking this product concurrently with other medications containing acetaminophen can also lead to severe liver damage. Furthermore, the risk of liver damage is heightened for individuals who consume three or more alcoholic drinks daily while using this product.

Prior to use, patients with liver disease are advised to 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 potential adverse effects.

Overdosage

Taking more than the recommended dosage can lead to serious health complications. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Prompt intervention is crucial, as the onset of symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of proactive management even in the absence of observable signs or symptoms.

Healthcare professionals should ensure that patients and caregivers are aware of these critical steps to mitigate the risks associated with overdosage.

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 identified several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

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 cautioned against using this product to induce sleep in children. They should be instructed to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the product 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. New symptoms that arise should also prompt a consultation with a healthcare provider.

Patients should be made aware that if a cough returns or occurs with a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition. When using this product, patients must adhere strictly to the recommended dosage and be informed that excitability may occur, particularly in children. Marked drowsiness is a potential side effect, and patients should be advised to avoid alcoholic beverages while using this product.

Patients should exercise caution when driving or operating machinery due to the risk of drowsiness. They should also be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Before using this product, patients should be encouraged to consult a healthcare provider 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, breathing problems, chronic cough related to smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients should seek advice from a doctor or pharmacist if they are taking sedatives, tranquilizers, or 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 room temperature, ensuring that it is protected from excessive heat to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for preserving the quality 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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Night Time Severe Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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