Nuvicare Daytime Cold and Flu Softgel

Description

PP0129-01 NC(nosymbol)-Daytime Cold+Flu Soft Gels are formulated to provide relief from cold and flu symptoms. Each soft gel contains active ingredients designed to alleviate discomfort associated with these conditions. The product is presented in a dosage form of soft gels, with a total count of 10 per package. The formulation is intended for daytime use, ensuring that users can manage symptoms effectively while maintaining daily activities.

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

The medication should be taken only as directed. Adults and children aged 12 years and older are advised to take 2 softgels orally with water every 4 hours, not to exceed 8 softgels within a 24-hour period. For children aged 4 to under 12 years, it is recommended to consult a physician before administration. The use of this medication is not indicated for children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently 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 medication, a healthcare professional should be consulted prior to use.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

The use of this product necessitates caution due to the potential for severe liver damage. Healthcare professionals should advise patients against exceeding four doses within a 24-hour period, as this represents the maximum daily dosage. Additionally, patients should be cautioned about the concurrent use of other medications containing acetaminophen and the consumption of three or more alcoholic beverages daily while using this product, as these factors significantly increase the risk of liver injury.

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

Healthcare providers should also recommend that patients stop using the product and seek medical advice if any of the following occur:

• Pain, cough, or nasal congestion worsens or lasts longer than seven days.

• New symptoms develop.

• Symptoms of nervousness, dizziness, or sleeplessness arise.

• Fever worsens or persists for more than three days.

• Redness or swelling is observed.

• Cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious underlying condition.

Monitoring for these symptoms is essential to ensure patient safety and to facilitate timely medical intervention when necessary.

Side Effects

Severe skin reactions may occur in patients, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients should be aware of the potential for severe liver damage, particularly if they exceed four doses within a 24-hour period, which is the maximum recommended daily amount for this product. The risk of liver damage is also heightened when used in conjunction with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should discontinue use and seek medical advice if they experience worsening pain, cough, or nasal congestion lasting more than seven days, the emergence of new symptoms, nervousness, dizziness, or sleeplessness, a fever that worsens or lasts more than three days, or the presence of redness or swelling. Additionally, if a cough recurs or occurs with a rash or headache that persists, these may indicate a serious condition requiring medical evaluation.

Before using this product, patients should consult a doctor if they have a history of liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Those with a cough that produces excessive phlegm or a persistent or chronic cough associated with smoking, asthma, or emphysema should also seek medical advice prior to use.

Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product to avoid potential interactions.

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, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, as well as for a period of two weeks following the discontinuation of an MAOI. The combination may lead to serious and potentially life-threatening interactions.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential alterations in the effectiveness of warfarin therapy.

Packaging & NDC

Below are the non-prescription pack sizes of Nuvicare Daytime Cold and Flu Softgel (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may take 2 softgels with water every 4 hours. For children aged 4 to under 12 years, it is advised to consult a doctor before use. The product is not recommended for children under 4 years of age.

It is important to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Quick medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information available regarding age considerations, dosage adjustments, safety concerns, or special precautions associated with the use of this medication. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population. Adjustments to dosage may be necessary based on individual patient assessments and clinical judgment.

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 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

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

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 4 doses within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks daily while using this product. Given the potential for increased susceptibility to acetaminophen-related hepatotoxicity in this population, careful consideration of liver function and adherence to recommended dosing guidelines is essential to minimize the risk of severe liver damage. Regular monitoring of liver function tests may be warranted in patients with significant hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Severe skin reactions have been reported, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately and medical assistance sought.

Additionally, new symptoms including nervousness, dizziness, or sleeplessness have been observed. These symptoms may indicate a serious condition, particularly if accompanied by a returning cough or if they occur alongside a rash or persistent headache. Prompt medical attention is essential for both adults and children in cases of overdose.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that they should not 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 with a doctor or pharmacist.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If patients are unsure whether their prescription includes an MAOI, they should seek guidance from a healthcare professional.

Patients should be instructed to discontinue use and consult a doctor if their pain, cough, or nasal congestion worsens or persists for more than seven days. They should also be advised to stop use and seek medical advice if new symptoms arise, or if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be informed to stop use and contact a doctor if their fever worsens or lasts longer than three days, or if they notice any redness or swelling.

Patients should be made aware that if their cough returns or occurs with a rash or headache that lasts, they should seek medical attention, as these could indicate a serious condition. It is crucial to emphasize that patients must not exceed the recommended dosage while using this product.

Before using this medication, patients should be encouraged to consult a doctor if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients should be advised to seek medical advice if they have a cough that produces excessive phlegm or if they have a persistent or chronic cough associated with smoking, asthma, or emphysema. Lastly, patients taking the blood-thinning medication warfarin should also consult a doctor 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, maintaining a range between 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, cold, and humidity to ensure the integrity and efficacy of the product. Proper storage conditions are crucial for maintaining quality and should be adhered to at all times.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare 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 at 1-800-222-1222, 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 Nuvicare Daytime Cold and Flu Softgel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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