Nite-Time

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, fever, 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 available in a liquid dosage form, with a total volume of 6 FL OZ (177 mL), and is presented in an original 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

Healthcare professionals are advised to administer the medication strictly as recommended, adhering to the specified dosage guidelines to avoid the risk of overdose.

The medication should be measured using a dose cup or a tablespoon (TBSP) for accurate dosing. The maximum allowable dosage is four doses within a 24-hour period.

When administering Nite Time at night and Day Time during the day, the total combined dosage of both formulations must not exceed four doses in a 24-hour timeframe. It is essential to monitor the total intake to ensure patient safety and compliance with the dosing recommendations.

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.

This 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 the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Additionally, this product should not be used to induce sleepiness in children.

It is also advised to adhere strictly to the recommended dosage and to 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 doses within a 24-hour period (the maximum daily amount), concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic beverages daily while using this product.

Allergy Alert Acetaminophen has the potential to cause severe skin reactions. Symptoms 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 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

Stop Use and Ask a Doctor If

• Redness or swelling is observed.

• Symptoms do not improve within 7 days or are accompanied by fever.

• Fever worsens or lasts more than 3 days.

• New symptoms develop.

• Cough persists for more than 7 days, recurs, or occurs with fever, rash, or a headache that lasts.

Healthcare professionals are advised to monitor patients closely for these signs and symptoms to ensure timely intervention and management.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. Patients are advised that taking more than four doses in a 24-hour period, using other medications containing acetaminophen, or consuming three or more alcoholic drinks can increase the risk of liver damage. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no symptoms are initially apparent.

Allergic reactions may also occur, with acetaminophen potentially causing severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any skin reaction is observed, patients should discontinue use and seek medical assistance without delay.

Patients should consult a doctor if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, if redness or swelling is present, if symptoms do not improve within seven days, or if fever worsens or lasts more than three days, medical advice should be sought. New symptoms or a cough that lasts more than seven days, recurs, or occurs with fever, rash, or headache should also prompt a consultation with a healthcare provider.

Certain pre-existing conditions warrant caution. Patients with a sodium-restricted diet, liver disease, glaucoma, or chronic respiratory issues such as asthma, chronic bronchitis, or emphysema should consult a doctor before use. Furthermore, individuals experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to using this product.

Patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a doctor or pharmacist before use to avoid potential interactions.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as there may be an increased risk of additive central nervous system depression.

Additionally, it is advisable to seek guidance from a healthcare provider if the patient is using warfarin, a blood-thinning agent, due to potential interactions that could affect anticoagulation control.

This medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or nonprescription, to avoid the risk of acetaminophen overdose.

Furthermore, the use of this medication 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, and co-administration may lead to serious adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Nite-Time (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be monitored closely for potential excitability, which may occur particularly in children. Additionally, marked drowsiness has been reported in this population. It is crucial to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is essential for both children and adults, even if no signs or symptoms are initially 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 should consult a healthcare professional before 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 discuss their individual circumstances with their healthcare provider to ensure appropriate management during pregnancy.

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 considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 4 doses within a 24-hour period to avoid the risk of severe liver damage. Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen, as well as the consumption of three or more alcoholic drinks daily while using this product.

Monitoring of liver function is recommended for patients with compromised liver function to ensure safety and efficacy. Regular assessment of liver enzymes may be warranted to detect any potential hepatotoxicity early.

Overdosage

Taking more than the recommended dose of the 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.

Quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. Early recognition and management of an overdose can significantly improve outcomes and mitigate potential health risks.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed that acetaminophen may cause severe skin reactions. Reports indicate 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 a 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 stop use and consult a doctor if a fever worsens or persists for more than three days, if new symptoms arise, or if a cough lasts longer than seven days, recurs, or occurs with fever, rash, or a persistent headache.

While using this product, patients should be reminded to adhere strictly to the recommended dosage and to avoid consuming alcoholic beverages. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should exercise caution when driving or operating machinery, as drowsiness may be exacerbated by alcohol, sedatives, or tranquilizers.

Patients should be encouraged to consult a doctor before using this product 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, asthma, chronic bronchitis, or emphysema. Additionally, patients with difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use. Finally, patients taking sedatives, tranquilizers, or 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 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-Time, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)