Nuvicare Daytime Cold and Flu Softgel

Description

PP0143-00 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 their symptoms 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 minor aches and pains, headache, sore throat, nasal congestion, fever, and cough due to minor throat and bronchial irritation.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication is to be taken orally, with water, as directed. For adults and children aged 12 years and over, the recommended dosage is 2 softgels every 4 hours, not to exceed 8 softgels within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a physician before administration. 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, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to use.

• Exceeding the recommended dosage is contraindicated, as it may lead to adverse effects.

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.

• Patients experience nervousness, dizziness, or sleeplessness.

• 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 adverse reactions may occur in patients using this product. Notably, severe skin reactions have been reported, which may include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

There is a significant risk of severe liver damage associated with the use of this product, particularly if patients exceed the maximum recommended dosage of 4 doses within a 24-hour period, use it concurrently with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be vigilant for severe sore throat symptoms that persist for more than 2 days or are accompanied by fever, headache, rash, nausea, or vomiting, and should consult a healthcare provider promptly in such cases.

Patients are also advised to stop use and consult a doctor if any of the following occur: worsening pain, cough, or nasal congestion lasting more than 7 days; the emergence of new symptoms; nervousness, dizziness, or sleeplessness; fever worsening or lasting more than 3 days; presence of redness or swelling; or a cough that recurs or is accompanied by a rash or headache lasting for an extended period, as these may indicate a serious condition.

Before using this product, patients should consult a healthcare provider if they have any of the following conditions: liver disease, diabetes, heart disease, thyroid disease, high blood pressure, trouble urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients should seek advice from a doctor or pharmacist if they are taking the blood-thinning medication warfarin.

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), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be administered for at least two 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 safe use and to mitigate the risk of altered anticoagulant effects.

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 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 adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted clinical data 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 currently no available data regarding 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

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. Severe liver damage may occur if patients exceed the maximum daily amount of 4 doses within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also important for patients with compromised liver function to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks daily while using this product is contraindicated, as it may exacerbate the potential for severe liver damage. Regular assessment of liver function is recommended for patients with hepatic impairment to ensure safe use of this medication.

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 based 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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

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 taken one within the last two weeks. Patients should be advised to ask their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to stop using the product and seek medical advice if their pain, cough, or nasal congestion worsens or persists for more than seven days. They should also be advised to discontinue use and consult a doctor if new symptoms arise, or if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be informed to stop use and seek medical attention if their fever worsens or lasts more 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 persistent headache, 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.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have any of the following conditions: liver disease, diabetes, heart disease, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice before use. Furthermore, patients should be advised to consult a doctor if they have a cough accompanied by excessive phlegm (mucus). Lastly, patients taking the blood-thinning medication warfarin should be encouraged to discuss their use of this product with a doctor or pharmacist 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 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 of the product. Proper storage conditions are crucial for maintaining the product's efficacy 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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.

View product document (PDF)