Severe Nighttime Cold and Flu

Description

This formulation is a maximum strength nighttime cold and flu medication, comparable to Vicks® NyQuil® Severe. It contains a combination of active ingredients designed to alleviate symptoms associated with severe cold and flu. The active components include acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, functioning as a cough suppressant; doxylamine succinate, an antihistamine; and phenylephrine HCl, which acts as a nasal decongestant. The product is presented in the form of softgels, with a total of 48 softgels per package.

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. 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 as needed.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

• Use in children for the purpose of inducing sleep is contraindicated.

• The product should not be used in excess of the directed dosage.

• Consumption of alcoholic beverages while using this product is not recommended.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4 doses within a 24-hour period (the maximum daily amount), concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Healthcare professionals should advise patients to seek prompt medical attention if a sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting. Additionally, acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any skin reaction occur, patients must discontinue use immediately and seek medical assistance.

It is crucial to inform patients that taking more than the directed dosage can result in serious health complications. In the event of an overdose, immediate medical help should be sought, or the Poison Control Center should be contacted without delay, as rapid medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

General precautions should be taken for patients with the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, cough associated with excessive phlegm, or chronic respiratory issues such as smoking-related conditions, asthma, chronic bronchitis, or emphysema. Patients experiencing difficulty urinating due to an enlarged prostate gland should also consult a healthcare provider prior to use. Furthermore, it is advisable for patients to consult a doctor or pharmacist if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

Patients should be instructed to discontinue use and contact a healthcare professional 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.

Side Effects

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

Patients should be aware that if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a doctor promptly. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any skin reaction occurs, patients are advised to discontinue use and seek medical assistance immediately.

In clinical settings, excitability has been reported, particularly in children, and marked drowsiness may occur in some patients. It is recommended that patients avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is advised when driving a motor vehicle or operating machinery.

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 is present; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that lasts.

Before using this product, patients should seek medical advice if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or if they experience a cough associated with excessive phlegm. Patients with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should also consult a doctor. Furthermore, those experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use.

Patients taking sedatives or tranquilizers, or those on the blood-thinning medication warfarin, should consult a doctor or pharmacist before using this product.

An overdose of this product can lead to serious health complications. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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 two 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 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 due to potential interactions.

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 Severe Nighttime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride). 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. For dosing, adults and children aged 12 years and older may take 2 softgels with water every 4 hours, not to exceed 4 doses within 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 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 therapeutic response, 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. 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 no specific data available regarding the excretion of this medication in 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 absence of 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. Severe liver damage may occur if patients exceed the maximum daily amount of 4 doses within a 24-hour period. Additionally, patients should avoid taking this product in conjunction with other medications that contain acetaminophen, as this can further increase the risk of liver damage.

It is also advised that patients limit alcohol consumption to fewer than 3 drinks per day while using this product, as excessive alcohol intake can exacerbate the potential for liver injury.

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

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 effects of an overdose may not be immediately apparent.

Both adults and children are at risk, and quick medical attention is essential even in the absence of noticeable signs or symptoms. This proactive approach can significantly mitigate the potential adverse effects associated with overdosage.

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 specific details regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, users are encouraged to stop use and consult a healthcare professional if they experience symptoms such as nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 7 days; if fever intensifies or lasts more than 3 days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs alongside a rash or headache that persists. These symptoms may indicate a serious condition requiring medical evaluation.

Furthermore, there is a warning regarding overdose, as exceeding the recommended dosage can lead to serious health complications. In cases of overdose, it is crucial to seek medical help or contact a Poison Control Center promptly, as timely medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 medication 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 or a recurrence of cough, especially if accompanied by a rash or persistent headache, should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

While using this product, patients should be reminded not to exceed the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, given the potential for increased drowsiness when combined with alcohol, sedatives, or tranquilizers.

Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or those experiencing a cough with excessive phlegm should be encouraged to consult a doctor before using this product. Additionally, patients with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use. Those who have difficulty urinating due to an enlarged prostate gland, as well as individuals taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should also be advised to consult a healthcare provider or pharmacist before using this product.

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 to maintain its integrity and efficacy. Proper handling should be observed to ensure optimal conditions are met throughout the storage period.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 softgels taken with water every 4 hours. For children aged 4 to under 12 years, it is advised to consult a doctor before use, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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