Day-Time 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, including minor aches and pains, headache, sore throat, fever, nasal congestion, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

The medication should be taken only as recommended, adhering to the overdose warning. A dosage cup or tablespoon (TBSP) should be utilized for accurate measurement. It is imperative not to exceed 4 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL (2 TBSP) every 4 hours. For children aged 6 years to under 12 years, the dosage is 15 mL (1 TBSP) every 4 hours. For children aged 4 years to under 6 years, it is advised to consult a physician for appropriate dosing. The medication is not recommended for children under 4 years of age.

When utilizing both Day Time and Night Time products, healthcare professionals should ensure that each label is carefully read to confirm the correct dosing.

Contraindications

Use of this product is contraindicated in the following situations:

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for psychiatric or emotional conditions, or Parkinson's disease, or within 2 weeks of discontinuing such medication. The combination may lead to serious interactions. If uncertain whether a prescription drug contains an MAOI, consult a healthcare professional.

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, seek advice from a healthcare professional.

• Use is not recommended beyond the directed dosage, as exceeding this may result in overdose.

• Alcoholic beverages should be avoided while using this product due to potential adverse effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if an adult or child exceeds four doses within a 24-hour period, which is the maximum recommended daily amount. Additionally, caution should be exercised if the product is taken concurrently with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should also be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly.

Patients should be advised to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, they should report any new symptoms, worsening fever lasting more than three days, or pain and cough that persist beyond five days in children or seven days in adults. Redness or swelling should also prompt a consultation, as well as a recurrence of cough accompanied by rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition that requires further evaluation.

Emergency medical assistance should be sought if any severe adverse reactions occur, although specific instructions for such situations are not detailed in the provided information.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is four doses in 24 hours, is exceeded. This risk is heightened if the product is taken in conjunction with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product. In cases of overdose, which can lead to serious health problems including liver damage, immediate medical attention is critical. Patients should seek professional assistance or contact a Poison Control Center without delay, even if no signs or symptoms are present.

Patients may also experience severe skin reactions due to acetaminophen, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to stop use and seek medical help immediately. Additionally, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a doctor promptly.

Patients are advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, sleeplessness, new symptoms, worsening fever lasting more than three days, or if pain or cough persists beyond five days in children or seven days in adults. The presence of redness or swelling, or a cough that returns or occurs with a rash or headache lasting, should also prompt medical consultation, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or a cough accompanied by excessive phlegm should also seek medical advice prior to use. Furthermore, patients taking the blood thinner warfarin should consult a doctor or pharmacist before using this product.

Drug Interactions

Patients taking acetaminophen should consult a healthcare professional prior to use if they are concurrently using the anticoagulant warfarin. The combination may lead to an interaction that could affect the efficacy and safety of warfarin therapy.

Currently, there are no additional drug interactions or laboratory test interactions reported for acetaminophen. Therefore, routine monitoring or dosage adjustments are not indicated beyond the aforementioned consideration with warfarin.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 years to under 12 years may receive a dosage of 15 mL (1 tablespoon) every 4 hours. For children aged 4 years to under 6 years, it is advised to consult a healthcare professional before administration. The use of this medication is not recommended for children under 4 years of age.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Monitoring for efficacy and adverse effects is recommended in this population, given the lack of targeted data.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication 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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance 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 closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 4 doses within a 24-hour period. Additionally, patients must avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver damage.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product may significantly heighten the risk of severe liver damage. Therefore, careful consideration of liver function and adherence to recommended dosage guidelines is essential for the safe use of this product in patients with hepatic impairment.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, serious health complications may arise, including potential liver damage.

Recommended Actions In cases of accidental overdose, it is imperative to seek professional medical assistance immediately. Healthcare professionals should advise contacting a Poison Control Center without delay.

Symptoms and Management Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Early intervention can significantly mitigate the risk of severe health consequences.

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

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. Symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this and all medications out of the reach of children. Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. Patients should be advised to seek clarification from a healthcare professional if they are unsure whether a drug contains acetaminophen.

Patients should be counseled to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be instructed to stop use and seek medical advice if new symptoms arise, if fever worsens or persists for more than three days, or if pain or cough intensifies or lasts beyond five days in children or seven days in adults. Patients should also be advised to stop use and consult a doctor if they notice any redness or swelling, or if a cough returns or occurs alongside a rash or headache that persists, as these may indicate a serious condition.

When using this product, patients should be reminded not to exceed the recommended dosage and to avoid consuming alcoholic beverages. It is essential to encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice before use. Furthermore, patients should be advised to consult a doctor if they have a cough accompanied by excessive phlegm (mucus) or if they are taking the blood thinner warfarin.

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 room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)