Night Time Cold and Flu Relief

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

Patients should adhere strictly to the recommended dosage to avoid the risk of overdose. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every six hours as needed. It is imperative that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved prior to ingestion.

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

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently 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.

Additionally, the 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 any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Patients are also advised not to exceed the recommended dosage and to avoid the consumption of alcoholic beverages while using this product.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or respiratory issues such as chronic cough, asthma, chronic bronchitis, or emphysema. Additionally, patients taking blood thinners like warfarin or those on sedatives or tranquilizers should seek guidance from a healthcare provider or pharmacist before using this product.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, even if no symptoms are apparent.

Discontinuation of Use Patients should be advised to stop taking this product and consult a doctor if any of the following occur: worsening pain or cough lasting more than seven days, fever worsening or lasting more than three days, presence of redness or swelling, emergence of new symptoms, or recurrence of cough accompanied by rash or headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

While using this product, excitability may occur, particularly in children, and marked drowsiness may be experienced. The use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, necessitating caution when driving or operating machinery.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts longer than seven days, if fever worsens or persists for 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. These symptoms could indicate a serious condition.

An overdose warning is also pertinent; taking more than the recommended dose can lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Acetaminophen and warfarin co-administration may elevate the risk of bleeding. It is recommended to monitor the International Normalized Ratio (INR) closely in patients receiving both medications to ensure safe therapeutic levels.

Doxylamine has the potential to enhance the sedative effects of other central nervous system (CNS) depressants. This interaction may lead to increased drowsiness and a heightened risk of respiratory depression. Caution is advised when prescribing doxylamine in conjunction with other CNS depressants, and monitoring for excessive sedation and respiratory function is recommended.

Packaging & NDC

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

Pediatric Use

Children under 12 years should not use this medication. For adults and children aged 12 years and over, the recommended dosage is 2 softgels taken with water every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments for this product; however, caution is advised due to potential safety concerns. The formulation contains acetaminophen, which carries a risk of severe liver damage if taken in excess. This risk is particularly pertinent for geriatric patients who may have diminished liver function.

Additionally, elderly patients may exhibit increased sensitivity to the side effects of antihistamines, such as doxylamine, which can lead to significant drowsiness. Therefore, it is recommended that geriatric patients consult a healthcare provider prior to use, especially if they have pre-existing conditions such as liver disease, glaucoma, or urinary difficulties related to an enlarged prostate gland. Monitoring for adverse effects is advisable in this population to ensure safe and effective use of the product.

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 considered in these populations to ensure the safety of both the mother and the fetus or 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 individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use if they experience difficulty urinating due to an enlarged prostate gland. Additionally, it is advisable for patients to seek guidance from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, as well as sedatives or tranquilizers. Monitoring and appropriate dosing adjustments may be necessary in these cases to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be aware of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with known liver disease consult a healthcare professional prior to using this product. During the use of this product, patients are strongly encouraged to avoid alcoholic beverages to minimize the risk of liver damage.

In the event of an overdose, which can lead to significant liver injury, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are present.

Overdosage

Taking more than the recommended dose of the medication can lead to significant liver damage. It is crucial for healthcare professionals to recognize the seriousness of an overdose and the potential for severe health consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is essential, as quick medical attention can be critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risks associated with liver damage and other potential complications.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients not to exceed the recommended dosage, as taking more than the prescribed amount can lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are present.

Patients should be informed that excitability may occur, particularly in children, and they should be cautious about engaging in activities that require alertness. Marked drowsiness is a potential side effect, and patients should be warned that the use of alcohol, sedatives, and tranquilizers can exacerbate this drowsiness. Therefore, it is advisable for patients to avoid alcoholic beverages while taking this medication.

Additionally, healthcare providers should emphasize the importance of being careful when driving a motor vehicle or operating machinery, as drowsiness may impair their ability to perform these tasks safely.

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 a temperature range of 15-30ºC (59-86ºF) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, which may compromise the integrity of the product. Proper storage conditions are crucial for ensuring the quality and safety 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 Night Time Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)