Nighttime Cold and Flu Relief

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, 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. It is imperative that the softgels are swallowed whole; they should not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication.

This product is not intended for use in children under 12 years of age.

When utilizing other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each product label to confirm appropriate dosing and avoid exceeding the maximum dosage.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction 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.

The product is also contraindicated in individuals 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, a healthcare professional should be consulted prior to use.

Additionally, patients should not exceed the recommended dosage and should 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 arise, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists beyond two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

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, 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 right away, regardless of whether symptoms are present.

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 adverse reactions associated with this product include significant liver damage, which may occur if patients exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Patients should be aware that acetaminophen may also lead to severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients are advised to consult a healthcare professional if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, individuals should stop using the product and seek medical advice if pain or cough worsens or lasts longer than seven days, if fever worsens or persists beyond three days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition.

While using this product, patients should adhere to the recommended dosage to avoid adverse effects. Notably, excitability may occur, particularly in children, and marked drowsiness is a potential side effect. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, necessitating caution when driving or operating machinery.

In cases of overdose, which can lead to liver damage, immediate medical attention is crucial. Patients should contact a healthcare provider or a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are apparent, as prompt intervention is essential for both adults and children.

Drug Interactions

Co-administration of acetaminophen and warfarin may elevate the risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving this combination to ensure safe therapeutic levels.

The concomitant use of alcohol, sedatives, and tranquilizers with this product may potentiate drowsiness. Caution is advised when these substances are used together, and patients should be monitored for increased sedation and impairment.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 softgels taken with water every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children. 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 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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients 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 a history of liver disease consult a healthcare professional prior to using this product. Monitoring of liver function may be necessary for patients with compromised liver function, particularly if they are at risk of exceeding the recommended dosage or engaging in behaviors that could exacerbate liver damage.

In the event of an overdose, which can lead to significant liver damage, 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 initially apparent.

Overdosage

In cases of overdosage, it is crucial to recognize the potential for serious health consequences, particularly concerning liver damage. Healthcare professionals should be aware that exceeding the recommended dosage can lead to significant adverse effects.

Recommended Actions In the event of an overdose, immediate medical assistance is essential. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt medical intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Potential Symptoms While specific symptoms of overdose may not always be evident, the risk of liver damage underscores the importance of vigilance. Healthcare professionals should monitor for any signs of hepatic impairment and be prepared to initiate appropriate management protocols.

Management Procedures Upon confirmation of an overdose, healthcare providers should follow established guidelines for the assessment and treatment of liver toxicity. This may include supportive care and monitoring of liver function tests, as well as considering the need for further interventions based on the severity of the overdose and the patient's clinical status.

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 severe skin reactions associated with acetaminophen. Reported symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance immediately.

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, patients must seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial 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 that marked drowsiness is a possible side effect. It is important to counsel patients to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Patients should exercise caution when driving or operating machinery due to the potential for increased drowsiness.

Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, a breathing problem or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if they have a cough that produces excessive phlegm (mucus).

Additionally, patients should be advised to speak with a doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

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, as this 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 Nighttime Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)