Nite-Time

Description

No description information is available for the 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 warning 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 advised to consult a physician for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

When administering both Nite Time and Day Time formulations, the total combined dosage should not exceed 4 doses in a 24-hour period. A dose cup or tablespoon should be utilized for accurate measurement.

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 a period of 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI.

• The product should not be used to induce sleepiness in children.

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 addition, healthcare providers should be vigilant regarding the management of sore throat symptoms. If a patient presents with a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

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

• Redness or swelling at the site of symptoms.

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

• Fever worsens or persists for more than 3 days.

• New symptoms develop.

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

While no specific laboratory tests or general precautions are outlined, healthcare professionals should remain alert to the potential for adverse effects and ensure appropriate monitoring of patients using 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 using the product 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. These symptoms may indicate a serious underlying condition.

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 inform their doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin, as these may interact with the product.

Drug Interactions

The use of Nite Time and Day Time in conjunction requires careful consideration to avoid potential overdose. It is advised to limit the total dosage to four doses within a 24-hour period when using both products.

Pharmacodynamic Interactions Co-administration of alcohol, sedatives, and tranquilizers with this product may result in increased drowsiness, leading to enhanced sedation effects. Caution is recommended when engaging in activities that require alertness.

Pharmacokinetic Interactions Patients taking warfarin, a blood-thinning medication, should consult a healthcare professional prior to using this product, as it may elevate the risk of bleeding.

Contraindications The concurrent use of this product with any other medication containing acetaminophen is contraindicated due to the risk of severe liver damage.

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 prior to use. The product is contraindicated in children under 4 years of age.

When using this product, there is a potential for excitability, particularly in pediatric patients.

In cases of 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 mothers.

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. It is important to note that severe liver damage may occur if patients exceed 4 doses (30 mL each) in 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, as well as the consumption of 3 or more alcoholic drinks daily while using this product. Due to the potential for increased risk of liver toxicity, careful consideration of liver function and adherence to dosing 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 based 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

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, pruritus, and urticaria. Gastrointestinal disturbances, including nausea and vomiting, have also been noted. Instances of drowsiness and sedation were reported, along with excitability, particularly in pediatric populations.

Additionally, cases of liver injury, including acute liver failure, have been documented. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, were also reported. Respiratory depression has been observed, particularly in situations of overdose. Furthermore, other unspecified adverse reactions have been reported in the postmarketing setting.

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 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, or if new symptoms arise. They should also be advised to seek medical attention if a cough lasts more than seven days, recurs, or occurs with fever, rash, or a persistent headache, as these may indicate a serious condition.

When using this product, patients should be reminded to adhere strictly to the recommended dosage and to avoid consuming alcoholic beverages, as alcohol may enhance drowsiness. Patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Caution should be exercised when driving or operating machinery while using this product.

Patients should be advised that the use of alcohol, sedatives, and tranquilizers may further increase drowsiness. It is essential for patients 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 asthma, chronic bronchitis, or emphysema. Patients with difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use. Furthermore, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should 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 efficacy and stability. No special handling requirements are necessary beyond standard storage practices.

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)