Daytime Nighttime Cold Flu Relief

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms in adults and children.

Daytime Use It is specifically indicated for the alleviation of the following symptoms:

• Cough due to minor throat and bronchial irritation

• Fever

• Sore throat

• Nasal congestion and sinus pressure

• Headache

• Minor aches and pains

Nighttime Use This drug is also indicated for the temporary relief of common cold and flu symptoms during nighttime, including:

• Cough due to minor throat and bronchial irritation

• Sore throat

• Headache

• Minor aches and pains

• Fever

• Runny nose and sneezing

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

Dosage and Administration

For daytime use, adults and children aged 12 years and older are instructed to take 2 softgels with water every 4 hours, not exceeding 4 doses within a 24-hour period. It is imperative that the softgels are swallowed whole and not crushed, chewed, or dissolved. The use of this product is not recommended for children under 12 years of age.

For nighttime use, adults and children aged 12 years and older should take 2 softgels with water every 6 hours, also adhering to the maximum limit of 4 doses in a 24-hour timeframe. Similar to daytime instructions, the softgels must be swallowed whole without crushing, chewing, or dissolving. This product is contraindicated for children under 12 years.

Healthcare professionals should advise patients to follow these guidelines strictly to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• The product should not be used 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 uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

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 total acetaminophen intake and advise patients on the risks associated with alcohol consumption during treatment.

Allergy Alert Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be instructed 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 advised to consult a physician promptly.

General Precautions Healthcare professionals should counsel patients to adhere strictly to the recommended dosage to avoid potential complications. Notably, excitability may occur, particularly in children, and marked drowsiness is a possible side effect. Patients should be cautioned against the consumption of alcoholic beverages, as alcohol, sedatives, and tranquilizers can exacerbate drowsiness. Caution is advised when driving or operating machinery due to the potential for impaired alertness.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center at 1-800-222-1222, regardless of whether symptoms are present, as rapid intervention is essential for both adults and children.

When to Contact a Doctor Patients should be instructed to stop taking the product and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms such as pain, cough, or nasal congestion worsen or persist beyond seven days, or if redness or swelling occurs, medical advice should be sought. Patients should also be vigilant for new symptoms, worsening fever lasting more than three days, or a cough that recurs or is accompanied by a rash or headache.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who 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 cause severe skin reactions, which can 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.

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.

Participants should stop use and seek medical advice if they experience any of the following symptoms: nervousness, dizziness, or sleeplessness; worsening pain, cough, or nasal congestion lasting more than seven days; redness or swelling; new symptoms; or fever that worsens or lasts more than three days. Additionally, if a cough recurs or occurs with a rash or headache that persists, medical consultation is recommended, as these may indicate a serious condition.

When using this product, it is crucial for patients to adhere to the recommended dosage to avoid adverse effects. Notably, excitability may occur, particularly in children, and marked drowsiness is a common side effect. Patients are advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution is recommended when driving or operating machinery.

In cases of overdose, which can lead to liver damage, patients should seek immediate medical attention or contact a Poison Control Center (1-800-222-1222). Prompt medical intervention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Nighttime Cold Flu Relief (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl). 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 4 hours for Daytime use and every 6 hours for Nighttime use.

Healthcare professionals should be aware that excitability may occur, particularly in children. 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 have specific geriatric use information, dosage adjustments, or safety concerns outlined in the provided drug insert. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the individual health status and potential comorbidities that may affect treatment outcomes. Regular monitoring and assessment of therapeutic response and adverse effects are recommended to ensure the safety and efficacy of the medication 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 associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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

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.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for these patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed 4,000 mg of acetaminophen in a 24-hour period.

• Concurrent use with other medications containing acetaminophen is contraindicated.

• Consumption of three or more alcoholic drinks daily while using this product is not recommended, as it may exacerbate the risk of liver damage.

Before using this product, patients with liver disease should consult a healthcare professional. They should also discontinue use and seek medical advice if any of the following occur: worsening pain, cough, or nasal congestion lasting more than 7 days; fever that worsens or persists for more than 3 days; presence of redness or swelling; emergence of new symptoms; or if a cough recurs or is accompanied by a rash or headache that lasts.

In the event of an overdose, which can lead to liver damage, immediate medical assistance should be sought. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

In cases of overdosage, it is imperative 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 intervention is crucial 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 recognition of an overdose, healthcare professionals should follow established guidelines for the assessment and management 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 clinical presentation.

In summary, the potential for liver damage necessitates a proactive approach in the management of overdose cases, emphasizing the importance of immediate medical attention and thorough evaluation.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section lacks any specific information. Additionally, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage, emphasizing that exceeding this dosage can lead to serious liver damage. In the event of an overdose, patients should be instructed to seek immediate medical assistance 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 symptoms are apparent.

Patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. It is essential to counsel patients to avoid alcoholic beverages, as the combination of alcohol with this medication can exacerbate drowsiness. Additionally, the use of sedatives and tranquilizers should be approached with caution, as these substances may further increase drowsiness.

Finally, healthcare providers should remind patients to exercise caution when driving or operating machinery, as drowsiness can 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 should be stored at a temperature range of 15° to 30°C (59° to 86°F). Care should be taken to avoid exposure to excessive heat, which may compromise the integrity of the product. Proper storage conditions are essential to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children.

Patients should be informed about the risks of overdose, as exceeding the recommended dose can lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, and patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)