Daytime Nighttime Cold Flu Relief

Description

No description information is available for the specified 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 to exceed 4 doses within a 24-hour period. It is essential that the softgels are swallowed whole; they must not be 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, again adhering to the maximum limit of 4 doses in a 24-hour period. As with daytime dosing, the softgels should be swallowed whole and must not be crushed, chewed, or dissolved. This product is also not suitable for children under 12 years.

Healthcare professionals should advise patients to follow these guidelines closely 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, 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 drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

Additionally, it is advised not to exceed the recommended dosage and to avoid alcoholic beverages, as alcohol may enhance drowsiness when combined with this product.

Warnings and Precautions

Severe liver damage may occur with the use of products containing acetaminophen if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using these products.

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 immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor promptly if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions must be emphasized to ensure safe use of these products. Patients should not exceed the recommended dosage. Excitability may occur, particularly in children, and marked drowsiness is a potential side effect. Alcoholic beverages should be avoided, as the combination of alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is advised when driving or operating machinery due to the risk of drowsiness.

In cases of overdose, immediate medical help should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed to stop taking the medication and contact their healthcare provider if they experience any of the following symptoms during the daytime: nervousness, dizziness, or sleeplessness; worsening pain, cough, or nasal congestion lasting more than seven days; presence of redness or swelling; occurrence of new symptoms; or if fever worsens or lasts more than three days.

During nighttime, patients should also seek medical advice if pain or cough worsens or lasts more than seven days, fever worsens or lasts more than three days, redness or swelling is present, new symptoms arise, or if cough returns with a rash or headache that persists. These symptoms may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur 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 these products.

Patients should be aware that acetaminophen may 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.

In cases of severe sore throat that 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.

Patients should stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness, if pain, cough, or nasal congestion worsens or lasts more than seven days, if redness or swelling is present, if new symptoms arise, or if fever worsens or lasts more than three days. Additionally, if a cough recurs or occurs with a rash or headache that lasts, medical advice should be sought.

When using this product, particularly at night, patients may experience excitability, especially in children, and marked drowsiness. It is recommended to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is advised when driving a motor vehicle or operating machinery due to the potential for increased drowsiness.

Drug Interactions

Acetaminophen has several notable drug interactions that warrant careful consideration.

Pharmacodynamic Interactions

Acetaminophen may increase the risk of liver damage when used concurrently with other medications containing acetaminophen or when consumed with three or more alcoholic beverages daily. Patients should be advised to avoid combining these substances to mitigate the risk of hepatotoxicity.

Pharmacokinetic Interactions

The concomitant use of acetaminophen with prescription monoamine oxidase inhibitors (MAOIs) can result in serious interactions. It is recommended that acetaminophen be avoided during MAOI therapy and for at least two weeks following the cessation of MAOI treatment to prevent adverse effects.

Additionally, patients who are on warfarin therapy should consult their healthcare provider prior to using acetaminophen. This is important as acetaminophen may influence International Normalized Ratio (INR) levels, potentially affecting anticoagulation control. Monitoring of INR levels may be necessary in these patients.

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 patients 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 utilize this product, as it is indicated for adults and children aged 12 years and older. However, there are no specific dosage adjustments or safety concerns outlined for this population in the available data.

Healthcare providers should remain vigilant when prescribing this product to geriatric patients, considering the general principles of pharmacotherapy in older adults, such as the potential for altered pharmacokinetics and pharmacodynamics. Continuous monitoring for efficacy and adverse effects is advisable, as individual responses may vary.

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, as well as any available data regarding fetal outcomes and maternal health. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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 medication in 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 that these products contain acetaminophen, which carries a risk of severe liver damage. It is crucial for patients to adhere to the following guidelines to minimize this risk:

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

• Caution is advised when using these products in conjunction with other medications that contain acetaminophen, as this may increase the risk of liver damage.

• Consumption of three or more alcoholic drinks daily while using these products is not recommended, as it may exacerbate liver-related risks.

Before using these products, patients with liver disease should consult a healthcare professional.

Patients are advised to discontinue use and seek medical advice if symptoms such as pain, cough, or nasal congestion worsen or persist for more than seven days.

In the event of an overdose, which can lead to liver damage, immediate medical assistance should be sought. Patients should 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 providers 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 does not contain any relevant information at this time. Additionally, there is no information available pertaining to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notably, severe skin reactions have been reported, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

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 consumption of alcohol, sedatives, and tranquilizers can exacerbate drowsiness. Additionally, patients should be cautioned about the potential risks associated with driving a motor vehicle or operating machinery while under the influence of this medication, as it 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° to 30°C (59° to 86°F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to maintain the efficacy and safety of the product throughout its shelf life.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 softgels with water every 4 hours during the daytime and every 6 hours at nighttime. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is crucial to keep the product out of reach of children.

Patients should be informed of the overdose warning, as exceeding the recommended dose can lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

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)