Nighttime Cold and Flu

Description

The drug is a combination of active ingredients, though specific chemical names and physical characteristics of these ingredients are not detailed. Information regarding inactive ingredients, formulation details, dosage form, and strength is also not provided. No further descriptive information about the drug is available.

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, headache, fever, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Healthcare professionals are advised to administer the medication strictly as directed, adhering to the overdose warning. The dosing should be measured exclusively with the dosing cup provided, which should be kept with the product to ensure accurate measurement.

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

This medication is not recommended for use in children under 12 years of age.

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. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that adults and children over 12 years of age must not exceed 4 doses (30 mL each) within a 24-hour period, as this represents the maximum daily amount. Additionally, caution is warranted when this product is taken concurrently with other medications containing acetaminophen. Patients who consume 3 or more alcoholic drinks daily while using this product are at an increased risk for liver damage and should be closely monitored.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a 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 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative that patients consult a healthcare provider promptly.

Healthcare professionals should advise patients to stop use and seek medical advice if any of the following occur: pain or cough worsens or lasts longer than 7 days; fever worsens or lasts longer than 3 days; redness or swelling is observed; new symptoms develop; or if cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

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

Severe liver damage may occur in patients who exceed the maximum daily dosage of 4 doses (30 mL each) within a 24-hour period, particularly in adults and children over 12 years of age. The risk of liver damage is heightened if the product is taken in conjunction with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients experiencing a severe sore throat that lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

In the event of an overdose, which may lead to serious health complications including liver damage, it is crucial for patients to seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should discontinue use and consult a doctor if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients should consult a healthcare provider if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems, including 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 taking sedatives or tranquilizers, or those on the blood-thinning medication warfarin, should also consult a doctor or pharmacist before using this product.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or for Parkinson’s disease. It is advised to avoid this medication for at least two weeks after discontinuing an MAOI to prevent serious interactions.

Patients should consult a healthcare professional before using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects and increase the risk of drowsiness.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider prior to using this medication, as there may be an increased risk of bleeding.

Caution is advised when consuming alcohol, as it may further increase drowsiness when taken in conjunction with this medication, as well as with sedatives and tranquilizers. Monitoring for excessive sedation is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cold and Flu (acetaminophen, doxylamine succinate and dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Caution is advised when administering this product, as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately 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 adverse effects or changes in therapeutic response, 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 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 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. Severe liver damage may occur if the following conditions are met:

• Adults and children over 12 years of age should not exceed 4 doses (30 mL each) in a 24-hour period, as this is the maximum daily amount for this product.

• Caution is advised when this product is taken concurrently with other medications containing acetaminophen, as this may increase the risk of liver damage.

• Patients who consume 3 or more alcoholic drinks daily while using this product are at an elevated risk for severe liver damage.

It is recommended that healthcare providers assess liver function and consider dosage adjustments or alternative therapies for patients with compromised liver function to mitigate the risk of hepatotoxicity. Regular monitoring of liver enzymes may be warranted in these patients to ensure safety and efficacy.

Overdosage

Taking more than the recommended dose of the medication can lead to serious health complications, particularly liver damage. It is essential for healthcare professionals to recognize the potential severity of an overdose and to act promptly.

In the event of an accidental overdose, immediate professional assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on management and treatment options.

Quick medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Early intervention can significantly improve outcomes and mitigate the risk of severe health issues.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include 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 product out of the 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 have taken one within the past two weeks. 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 if they have a history of allergic reactions to it or any of its ingredients. They should be instructed to stop using the product and seek medical advice if their pain or cough worsens or persists for more than seven days, if their fever worsens or lasts more than three days, or if they notice any redness or swelling. Additionally, patients should be advised to consult a doctor if new symptoms arise or if a cough returns, especially if accompanied by a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should be reminded to adhere strictly to the recommended dosage to avoid the risk of overdose. They should also be advised to avoid alcoholic beverages while using this product, 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 due to the potential for drowsiness.

Patients should be encouraged to consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, smoking-related issues, 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 upon request. It is essential to store the product at room temperature, within the range of 15-30°C (59-86°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling should be observed to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Nighttime Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)