Daytime Nighttime Cold Flu Relief

Description

Acetaminophen, at a dosage of 325 mg, serves as a pain reliever and fever reducer. Dextromethorphan HBr, present at 10 mg, functions as a cough suppressant. Phenylephrine HCl, included at 5 mg, acts as a nasal decongestant. The formulation is presented in softgel form, specifically liquid-filled capsules. This product is alcohol-free and does not contain antihistamines.

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 indicated for the alleviation of the following symptoms:

• Cough due to minor throat and bronchial irritation

• Nasal congestion

• Headache

• Minor aches and pains

• Fever

• Sore throat

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 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 ensuring that no more than 4 doses are taken in a 24-hour period. As with daytime dosing, the softgels must be swallowed whole and should not be crushed, chewed, or dissolved. This formulation is also not suitable for children under 12 years.

Healthcare professionals should advise patients to adhere strictly to the recommended dosages 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.

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.

It is crucial to avoid using these products in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, patients should be directed to consult a healthcare provider. Additionally, these products should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Patients should be encouraged to verify with a healthcare professional if they are unsure whether their prescription includes an MAOI.

In cases of overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use 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; emergence of new symptoms; or if fever worsens or persists for more than three days. Additionally, a cough that recurs or occurs with a rash or headache that lasts may indicate a serious condition.

During nighttime, patients should also stop taking the product and consult their doctor if they experience worsening pain or cough lasting more than seven days, fever that worsens or lasts more than three days, presence of redness or swelling, emergence of new symptoms, or a cough that recurs or occurs with a rash or headache that lasts. These symptoms may signify a serious underlying condition that requires 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 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.

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

During daytime use, patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or lasts longer 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 persists, these may indicate a serious condition requiring medical evaluation.

For nighttime use, patients should also seek medical advice if pain or cough worsens or lasts more than seven days, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms occur, or if a cough returns or occurs with a rash or headache that lasts.

Patients using this product at night may experience excitability, particularly in children, as well as marked drowsiness. It is advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is recommended when driving or operating machinery.

An overdose of acetaminophen can lead to liver damage. Patients should seek immediate medical help or contact a Poison Control Center (1-800-222-1222) if an overdose is suspected, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 not recommended in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or for Parkinson’s disease, and should be avoided for at least two weeks after discontinuation of the MAOI. This combination may lead to serious adverse effects, including hypertensive crises.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding due to potential interactions.

Caution is advised when this medication is used in conjunction with alcohol, sedatives, or tranquilizers, as these substances may enhance drowsiness and impair cognitive and motor functions. Monitoring for increased sedation and potential respiratory depression is recommended in such cases.

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, as safety and efficacy have not been established in this population for both Daytime and Nighttime formulations. For patients aged 12 years and older, the recommended dosage for the Daytime formulation is 2 softgels taken with water every 4 hours, while the Nighttime formulation should be taken as 2 softgels with water every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children when using the Nighttime formulation. Additionally, marked drowsiness is a potential side effect associated with the Nighttime use. In the event of an overdose, it is crucial to seek immediate medical assistance 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 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 potential adverse effects or changes in efficacy, 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should be aware that these products contain acetaminophen, which poses a risk of severe liver damage. It is crucial for patients to adhere to the following guidelines to minimize the risk of liver injury:

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

• Caution is advised against the concurrent use of other medications containing acetaminophen, as this may lead to unintentional overdose.

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

Before using these products, patients with liver disease should consult a healthcare professional. Additionally, patients are advised to discontinue use and seek medical advice if symptoms such as pain, cough, or nasal congestion worsen or persist beyond seven days. They should also contact a healthcare provider if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious underlying condition.

In the event of an overdose, which can lead to liver damage, immediate medical assistance should be sought. Patients are encouraged 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

Taking more than the recommended dose of this medication can lead to significant liver damage. It is crucial for healthcare professionals to be aware of the potential severity of an overdose and the importance of prompt intervention.

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 for guidance on management. Quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Early intervention can be critical in mitigating the risks associated with overdose and ensuring patient safety.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For non-teratogenic effects, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. Additionally, there is no information provided in the nonclinical toxicology section or regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, emphasizing the importance of prompt attention for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage to avoid potential adverse effects. It is important to inform patients that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect.

Healthcare providers should counsel patients to avoid consuming alcoholic beverages while taking this medication, as alcohol, along with sedatives and tranquilizers, may enhance drowsiness. Additionally, patients should be cautioned about the risks associated with driving a motor vehicle or operating machinery, advising them to exercise caution due to the potential for impaired alertness.

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 should be informed about the oral administration of the medication, which is indicated for both daytime and nighttime use. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours during the day, not exceeding 4 doses in a 24-hour period. For nighttime use, the same dosage is advised every 6 hours, with the same maximum limit.

Clinicians should counsel patients on important safety information. Pregnant or breastfeeding individuals should consult a healthcare professional prior to use. It is crucial to keep the medication out of reach of children. An overdose warning is in place, as exceeding the recommended dose may lead to liver damage. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, 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.

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