Nuvicare Nighttime Cold and Flu Softgel

Description

PP0130-01 NC(nosymbol)-Nighttime Cold+Flu Soft Gels are formulated to provide relief from nighttime cold and flu symptoms. Each soft gel contains a proprietary blend of active ingredients designed to alleviate discomfort associated with colds and flu. The product is presented in a soft gel dosage form, facilitating ease of ingestion. The packaging contains 10 soft gels, ensuring a convenient supply for users seeking symptomatic relief during nighttime hours.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, sore throat, fever, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Patients should take the medication only as directed. The recommended dosage for adults and children aged 12 years and older is 2 softgels every 6 hours, not to exceed 8 softgels within a 24-hour period. It is advised to take the softgels with a full glass of water to ensure proper swallowing and absorption.

For children aged 4 to under 12 years, it is essential to consult a healthcare professional for appropriate dosing recommendations. 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:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is also contraindicated due to the risk of acetaminophen overdose.

Additionally, this product should be kept out of reach of children, and the recommended dosage should not be exceeded. Alcoholic beverages should be avoided, as they may enhance drowsiness when combined with this product. Caution is advised as alcohol, sedatives, and tranquilizers can further increase drowsiness.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, which is a maximum of 8 softgels within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications that contain acetaminophen or if they consume three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider without delay.

Patients should also be instructed to stop use and seek medical advice if any of the following occur: pain or cough worsens or lasts longer than seven days; new symptoms develop; fever worsens or persists beyond three days; redness or swelling is observed; or if cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 8 softgels within a 24-hour period, use 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 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.

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 consult a doctor if pain or cough worsens or lasts longer than seven days, if new symptoms arise, if fever worsens or persists for more than three days, if redness or swelling is observed, or if a cough recurs or occurs with a rash or headache that lasts. These symptoms may indicate a serious condition.

Prior to using this product, patients should seek medical advice if they have a history of liver disease, glaucoma, a cough that produces excessive phlegm, or any breathing problems, including chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland should consult a healthcare provider.

Patients taking the blood-thinning medication warfarin or those using sedatives or tranquilizers should also consult a doctor or pharmacist before use.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while taking MAOIs or for a period of two weeks following the discontinuation of an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease.

Caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking warfarin.

Additionally, the use of alcohol, sedatives, and tranquilizers in combination with this medication may enhance drowsiness. Patients should be monitored for increased sedation and advised to avoid activities that require full alertness until they understand how the combination affects them.

Packaging & NDC

Below are the non-prescription pack sizes of Nuvicare Nighttime Cold and Flu Softgel (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). 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 every 6 hours.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific information available 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 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 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 exercise caution 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 8 softgels 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.

Furthermore, patients with compromised liver function are advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product. Monitoring of liver function is recommended for patients with existing liver conditions or those who may be at increased risk for hepatic impairment. Regular assessment of liver enzymes may be warranted to ensure patient safety and to mitigate the risk of potential hepatotoxicity.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Quick intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Healthcare professionals are advised to utilize the Poison Control Center hotline at 1-800-222-1222 for guidance and support in managing overdose situations.

Prompt recognition and response to an overdose can significantly impact patient outcomes. Therefore, it is essential for healthcare providers to remain vigilant and proactive in addressing potential overdose cases.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and marked drowsiness has been observed. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is provided in the insert.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may present as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult with their doctor or pharmacist.

It is important to instruct patients not to use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. Patients should be advised to seek clarification from their healthcare provider if they are unsure about the presence of acetaminophen in their other medications.

Patients should be counseled to discontinue use and consult a doctor if their pain or cough worsens or persists for more than seven days. They should also be instructed to stop use and seek medical advice if new symptoms arise, if fever worsens or lasts more than three days, or if there is any redness or swelling. Additionally, patients should be made aware that a returning cough, especially if accompanied by a rash or persistent headache, may indicate a serious condition requiring medical attention.

When using this product, patients should be cautioned against exceeding the recommended dosage. They should be informed that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be warned to exercise caution when driving or operating machinery due to the potential for drowsiness. It is essential to recommend that patients consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, smoking-related issues, asthma, chronic bronchitis, or emphysema. Furthermore, patients should be advised to seek medical advice if they experience difficulty urinating due to an enlarged prostate gland.

Lastly, patients should be encouraged to consult their doctor or pharmacist before using this product if they are taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

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 a temperature range of 15-30°C (59 to 86°F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to maintain the efficacy and safety of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 softgels every 6 hours. For children aged 4 to under 12 years, it is advised to consult a doctor regarding appropriate use, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to seek medical advice if they are pregnant or breastfeeding. Patients are also advised to discontinue use and consult a doctor if pain or cough worsens or persists beyond 7 days, if new symptoms arise, if fever worsens or lasts more than 3 days, or if there is any redness or swelling. Additionally, patients should seek medical attention if a cough recurs or is accompanied by a rash or persistent headache.

Drug Information (PDF)

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

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