Nite-Time

Description

No description information is available for the specified drug.

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 should refer to the Overdose warnings for further guidance. For oral administration, a dose cup or tablespoon (TBSP) should be utilized to ensure accurate dosing.

For adults and children aged 12 years and older, the recommended dosage is 30 mL (2 TBSP) every 6 hours, with a maximum of 4 doses within a 24-hour period. For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The medication is not recommended for children under 4 years of age.

When using both Nite Time and Day Time formulations, it is essential to limit the total intake to 4 doses per 24 hours, regardless of the time of administration.

Contraindications

Use of this product is contraindicated in the following situations:

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

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions.

• For the purpose of inducing sleepiness in children, as this may pose safety risks.

Additionally, caution is advised when using this product, including adherence to the recommended dosage, avoidance of alcoholic beverages, and awareness of potential excitability, marked drowsiness, and impaired ability to operate vehicles or machinery. The use of alcohol, sedatives, and tranquilizers may further enhance 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 following guidelines to mitigate the risk of liver injury:

• Do not exceed 4 doses (30 mL each) within a 24-hour period, as this represents the maximum daily amount for this product.

• Avoid concurrent use with other medications containing acetaminophen.

• Limit alcohol consumption to fewer than 3 drinks per day while using this product.

In cases of sore throat, patients should be informed that if the sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, they should consult a healthcare provider promptly.

Patients should also be instructed to discontinue use and seek medical advice if any of the following occur:

• Redness or swelling at the site of application.

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

• Fever worsens or persists for more than 3 days.

• New symptoms develop.

• A cough lasts more than 7 days, recurs, or occurs with fever, rash, or a headache that lasts.

While no specific instructions for emergency medical help are provided, healthcare professionals should remain vigilant and prepared to address any adverse reactions or complications that may arise during treatment.

No laboratory tests are specified for monitoring; however, healthcare providers should consider the patient's overall health status and any potential risk factors when recommending this product.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed the maximum daily dosage of 4 doses (30 mL each) within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product. In the event of an overdose, which can lead to serious health complications, it is crucial for patients to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to stop use and consult a doctor if they experience redness or swelling, if symptoms do not improve within 7 days or are accompanied by fever, if fever worsens or persists for more than 3 days, if new symptoms arise, or if a cough lasts more than 7 days, recurs, or occurs with fever, rash, or a headache that lasts.

Before using this product, patients should consult a doctor if they have a sodium-restricted diet, liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use.

Patients should also consult a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin, as these may interact with the product.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should seek medical attention promptly.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking warfarin, a blood-thinning medication. The combination may elevate the risk of bleeding, necessitating careful monitoring and potential dosage adjustments.

Additionally, the concurrent use of alcohol, sedatives, and tranquilizers may enhance drowsiness associated with this product. This interaction could also impact the results of laboratory tests. It is advisable for patients to inform their healthcare provider of all medications and substances they are using to ensure appropriate monitoring and management of these interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Nite-Time (acetaminophen). 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. Caution is advised as excitability may occur, particularly in pediatric patients. For adults and children aged 12 years and older, the recommended dosage is 30 mL (2 tablespoons) every 6 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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently 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

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 patients exceed 4 doses (30 mL each) within a 24-hour period, which is the maximum daily amount for this product. Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen and should limit alcohol consumption to fewer than 3 drinks per day while using this product. Due to the potential for increased risk of liver toxicity, careful consideration of dosage and adherence to these guidelines is essential for patients with compromised liver function.

Overdosage

Taking more than the recommended dose of the medication can lead to serious health complications. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. 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 amount ingested and the individual’s health status. Therefore, it is essential to monitor the patient closely and provide supportive care as needed. Early recognition and management of overdose symptoms can significantly improve outcomes.

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 revealed reports of various adverse reactions associated with the use of the product. These include allergic reactions, such as anaphylaxis, and severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Instances of liver injury have been documented, with some cases progressing to acute liver failure.

Gastrointestinal bleeding and renal impairment have also been reported. Cardiac events, including arrhythmias and myocardial infarction, have been noted in the postmarketing data. Additionally, respiratory depression has been observed, particularly in patients with pre-existing respiratory conditions.

Drowsiness and sedation have been reported, especially in pediatric populations, alongside instances of excitability in children.

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 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 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.

When 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 while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

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. It is also advisable for patients to consult a doctor or pharmacist 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-Time, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)