Nite-Timecold/Flu Cherry

Description

Nite-Time COLD/FLU Medicine is a multi-symptom formulation designed to address various cold and flu symptoms. It contains acetaminophen, which serves as a pain reliever and fever reducer, effectively alleviating aches and sore throat. Dextromethorphan acts as a cough suppressant, while doxylamine succinate functions as an antihistamine, providing relief from sneezing and a runny nose. The product is presented in a 6 FL OZ (177 mL) liquid dosage form with a cherry flavor.

Uses and Indications

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

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

Dosage and Administration

The medication should be taken only as recommended, and healthcare professionals are advised to refer to the Overdose warnings for further guidance.

For adults and children aged 12 years and older, the recommended dosage is 30 mL (equivalent to 2 tablespoons) every 6 hours. It is important not to exceed 4 doses within a 24-hour period.

For children aged 4 to under 12 years, it is essential to consult a physician for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

When administering Nite Time at night and Day Time during the day, the total combined dosage should also be limited to 4 doses within a 24-hour period. A dose cup or tablespoon should be used for accurate measurement.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction 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 uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to use.

This product should not be used to induce sleepiness in children.

It is also essential to keep this product out of reach of children, adhere strictly to the recommended dosage, and avoid the consumption of alcoholic beverages while using this product.

Warnings and Precautions

Failure to adhere to the following warnings may result in serious health consequences.

Liver Warning This product contains acetaminophen, which can lead to severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Allergy Alert Acetaminophen has the potential to cause severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

Discontinuation of Use Patients should stop using this product and consult a doctor if any of the following occur: redness or swelling is present; symptoms do not improve within seven days or are accompanied by fever; fever worsens or lasts more than three days; new symptoms develop; or if a cough persists for more than seven days, recurs, or occurs with fever, rash, or a headache lasting longer than usual. These symptoms may indicate a serious underlying condition.

Emergency medical assistance should be sought if any severe reactions or complications arise.

No specific laboratory tests or general precautions are provided; however, healthcare professionals are advised to monitor patients for the aforementioned symptoms and reactions to ensure safe use of this product.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, 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 of severe sore throat that 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.

Taking more than the recommended dose of acetaminophen can lead to serious health complications. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center without delay, as timely medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and consult a doctor if they experience redness or swelling, if symptoms do not improve within seven days or are accompanied by fever, if fever worsens or persists for more than three days, if new symptoms arise, or if a cough lasts more than seven days, recurs, or occurs with fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition.

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.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease, as well as for a period of 2 weeks following the discontinuation of an MAOI.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these may enhance the sedative effects of the medication.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as potential interactions may affect anticoagulation control.

It is important to note that the concomitant use of alcohol, sedatives, and tranquilizers may lead to increased drowsiness, necessitating caution in activities requiring alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Nite-Timecold/Flu Cherry (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 contraindicated in children under 4 years of age. For dosing, adults and children 12 years and older may take 30 mL (2 tablespoons) every 6 hours, with a maximum of 4 doses in a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in children, and marked drowsiness is also a potential side effect.

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 potential adverse effects or changes in therapeutic response, given the lack of detailed information on the use of this medication in the elderly population. Individualized assessment and careful consideration of the patient's overall health status and comorbidities are recommended to ensure safe and effective use.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

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 drug in human 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if the total daily dose of acetaminophen exceeds 4,000 mg. Therefore, dosage adjustments may be necessary for patients with compromised liver function to prevent potential toxicity.

Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen, as this can further increase the risk of severe liver damage.

Furthermore, patients who consume three or more alcoholic drinks daily are at an elevated risk for liver damage while using this product. It is recommended that these patients either avoid alcohol consumption or consult with a healthcare professional to assess the safety of using this product in conjunction with their alcohol intake. Regular monitoring of liver function may be warranted in these cases to ensure patient safety.

Overdosage

Taking more than the recommended dose of this medication 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 onset of symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of acting swiftly even in the absence of noticeable signs or symptoms.

Healthcare professionals should ensure that patients and caregivers are aware of these critical steps to take in the case of an overdose, reinforcing the necessity of quick medical attention to mitigate potential health risks.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this product 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 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 sleepiness in children. They should be instructed to discontinue use and seek medical advice if they experience redness or swelling, if symptoms do not improve within seven days, or if symptoms are accompanied by a fever. Additionally, patients should be advised to stop use and consult a doctor if a fever worsens or persists for more than three days, or if new symptoms arise.

Healthcare providers should inform patients that if a cough lasts more than seven days, recurs, or occurs with fever, rash, or a persistent headache, they should seek medical attention, as these may indicate a serious condition. Patients should be reminded to adhere strictly to the recommended dosage and to avoid alcoholic beverages while using this product.

Patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. They should be cautioned to exercise care when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Before using this product, patients should be advised to consult a doctor if they are on a sodium-restricted diet, have liver disease, glaucoma, a cough with excessive phlegm, or any breathing problems such as chronic cough, smoking-related issues, asthma, chronic bronchitis, or emphysema. Additionally, patients should seek medical advice if they have difficulty urinating due to an enlarged prostate gland, or if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Nite-Timecold/Flu Cherry, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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