Night-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, headache, minor aches and pains, 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

The medication should be taken only as recommended, adhering to the overdose warning. For accurate dosing, a dose cup or tablespoon (TBSP) should be utilized.

Adults and children aged 12 years and older are advised to take 30 mL (2 TBSP) every 6 hours, with a maximum of 4 doses within a 24-hour period. For individuals taking both Night Time and Day Time formulations, the total combined doses must not exceed 4 doses in a 24-hour timeframe.

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

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

• Administration to induce sleepiness in children is contraindicated.

Additionally, the consumption of alcoholic beverages is discouraged, as it may enhance drowsiness when combined with this product. Use should not exceed the recommended dosage.

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 minimize the risk of liver injury: do not exceed 4 doses within a 24-hour period, avoid concurrent use with other medications containing acetaminophen, and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and 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 that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare provider promptly.

Patients should be instructed to stop use and contact their doctor if they experience redness or swelling, if symptoms do not improve within 7 days or are accompanied by fever, if fever worsens or lasts more than 3 days, if new symptoms develop, or if a cough persists for more than 7 days, recurs, or occurs with fever, rash, or headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

No specific laboratory tests or general precautions have been identified for this product. However, healthcare professionals should remain vigilant for any signs of adverse reactions or complications in patients using this medication.

Side Effects

Patients using this product should be aware of several potential adverse reactions, including serious warnings related to liver health and allergic reactions.

Severe liver damage may occur if patients exceed four doses within a 24-hour period, which is the maximum daily amount for this product. Additionally, the risk of liver damage increases if the product is taken in conjunction with other medications containing acetaminophen or if patients consume three or more alcoholic drinks daily while using this product.

Patients should also be alert for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

A sore throat warning is in place for patients experiencing severe sore throat symptoms that persist for more than two days, especially if accompanied by fever, headache, rash, nausea, or vomiting. In such cases, prompt consultation with a healthcare provider is recommended.

Overdosage of this product can lead to serious health complications. Patients are urged to seek medical help or contact a Poison Control Center immediately if they suspect an overdose, as timely medical intervention is crucial for both adults and children, even in the absence of noticeable 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 lasts more than three days, if new symptoms arise, or if a cough persists for more than seven days or recurs with fever, rash, or headache, as these may indicate a serious condition.

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

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

Drug Interactions

Acetaminophen has been identified to potentially increase the risk of bleeding when co-administered with warfarin. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving this combination to ensure safe therapeutic levels and to mitigate the risk of adverse effects.

No additional drug interactions or laboratory test interactions have been reported.

Packaging & NDC

Below are the non-prescription pack sizes of Night-Time (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 medication is not recommended for children under 4 years of age.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect that may affect pediatric patients.

In the event of an overdose, it is crucial to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including 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 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function 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, as exceeding this limit may result in severe liver damage.

Additionally, patients with compromised liver function must be aware that taking this product in conjunction with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, the risk of liver damage is heightened for patients who consume three or more alcoholic drinks daily while using this product. Therefore, it is advisable for patients with hepatic impairment to consult with a healthcare professional before using this product, particularly if they have a history of liver disease or alcohol use. Regular monitoring of liver function may be warranted in these patients to ensure safety and prevent potential adverse effects.

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 attention 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 intervention can significantly improve outcomes in cases of overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

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

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, or if new symptoms arise.

Healthcare providers should emphasize that if a cough lasts more than seven days, recurs, or occurs with fever, rash, or a persistent headache, patients should seek medical attention, as these may indicate a serious condition. Patients must 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. Caution should be advised when driving or operating machinery while using this product. Furthermore, patients should be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Before using this product, patients should consult their healthcare provider 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. Patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use. Lastly, 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 integrity and efficacy. 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 Night-Time, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)