Day-Time Cold and Flu Relief

Description

This product is identified by NDC 69517-160-10 and is available in a dosage form of 10 softgels. It is formulated for day-time relief of cold and flu symptoms, specifically targeting aches, fever, sore throat, nasal congestion, and cough. The active ingredients include acetaminophen, phenylephrine, and dextromethorphan. This formulation is comparable to the active ingredients found in Vicks Dayquil®.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

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

There are no specific contraindications listed for this product. However, it is important to note that taking more than the directed dosage can lead to serious health problems. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, liver damage may occur if more than four doses are taken within a 24-hour period, if it is used concurrently with other medications containing acetaminophen, or if consumed with three or more alcoholic drinks daily while using this product.

In the event of a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, it is advisable to consult a doctor or pharmacist. Additionally, this product must not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. If there is any doubt about the presence of an MAOI in a prescription drug, consultation with a healthcare professional is recommended.

Before using this product, individuals should seek medical advice if they have any of the following conditions: liver disease, heart disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, a cough that produces excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, it is essential to consult a doctor or pharmacist if taking the anticoagulant warfarin.

When using this product, it is crucial to adhere strictly to the recommended dosage.

Users should discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness; if symptoms worsen or persist beyond five days for children or seven days for adults; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious condition.

In the case of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are immediately apparent.

Side Effects

Severe liver damage may occur in patients who exceed the maximum recommended dosage of four doses within a 24-hour period, particularly when used in conjunction with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

Patients should be advised to seek medical attention if they experience a severe sore throat that lasts more than two days, especially if accompanied by fever, headache, rash, nausea, or vomiting.

Additionally, patients are instructed to discontinue use and consult a healthcare professional if they experience symptoms such as nervousness, dizziness, or sleeplessness. It is also important to seek medical advice if symptoms worsen or persist beyond five days in children or seven days in adults, if fever worsens or lasts more than three days, if there is any redness or swelling, if new symptoms develop, or if a cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires prompt evaluation.

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), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be administered for at least 2 weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Day-Time Cold and Flu Relief (acetaminophen, phenylephrine, dextromethorphan). 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 not recommended for children under 4 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 4 doses within a 24-hour period.

Healthcare professionals should advise parents and caregivers to monitor symptoms closely. If symptoms worsen or persist beyond 5 days in children, or 7 days in adults, medical advice should be sought. Additionally, if a fever in pediatric patients worsens or lasts more than 3 days, it is important to consult a healthcare provider.

An overdose warning is applicable; prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 potential for altered pharmacokinetics and pharmacodynamics in 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 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 safe use during pregnancy and lactation.

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 mothers.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed four doses within a 24-hour period, as this represents the maximum daily amount for this product. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks daily while using this product is contraindicated, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with the use of this product, which contains acetaminophen.

Maximum Daily Dosage Healthcare professionals should advise patients that the maximum recommended dosage is 4 doses within a 24-hour period. Exceeding this limit significantly increases the risk of liver injury.

Concurrent Use with Other Acetaminophen Products It is essential to caution patients against the concurrent use of this product with other medications that also contain acetaminophen. Such combinations can lead to an increased risk of severe liver damage.

Alcohol Consumption Patients should be informed that the consumption of three or more alcoholic drinks daily while using this product can further elevate the risk of liver damage. Healthcare providers should assess patients' alcohol intake and provide appropriate guidance.

Management of Overdosage In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should monitor liver function and consider the administration of N-acetylcysteine as an antidote, particularly if the overdose is identified within a critical time frame. Prompt intervention is crucial to mitigate the risk of severe hepatic injury.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients on the importance of adhering to the prescribed dosage of the medication. Emphasize that taking more than the directed amount can lead to serious health complications.

In the event of an overdose, patients should be instructed to seek medical assistance immediately or contact a Poison Control Center without delay. It is crucial to highlight that prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Storage and Handling

The product is supplied in a tamper-evident package that is safety sealed and child-resistant. It is essential to use the product only if the blisters are intact. In cases where the package is difficult to open, scissors may be used for assistance.

For optimal storage, the product should be kept at room temperature. It is advisable to retain the outer carton, as it contains complete warnings and product information necessary for safe usage.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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