Daytime 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 nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

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

Dosage and Administration

Patients should take the medication only as directed, adhering to the warnings provided. 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 four hours.

For children aged 4 to under 12 years, it is advised to consult a physician before administration. The medication is not recommended for children under 4 years of age.

When using other Daytime or Nighttime products, it is essential to carefully read each label to ensure correct dosing and avoid exceeding the recommended limits.

Contraindications

Use of this product is contraindicated in the following situations:

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

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOi) for depression, psychiatric or emotional conditions, or Parkinson's disease, or within 2 weeks of discontinuing such treatment. The combination may lead to serious interactions. 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

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, which is a maximum of 8 liquid caps within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications containing acetaminophen or consuming 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. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

Patients should be instructed to stop use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms worsen or persist beyond five days in children or seven days in adults, or if fever worsens or lasts more than three days, medical consultation is necessary. The presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than usual may indicate a serious condition requiring immediate attention.

In the event of an accidental overdose, it is imperative to seek emergency medical help or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Patients using this product should be aware of several potential adverse reactions, including serious warnings related to liver health and allergic reactions.

Severe liver damage may occur if patients exceed the maximum daily dosage of 8 liquid caps 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.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if they experience a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these may indicate a need for prompt medical consultation.

Common adverse reactions that warrant discontinuation of use and consultation with a healthcare provider include feelings of nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if symptoms worsen or persist beyond five days for children or seven days for adults, if fever worsens or lasts more than three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms could signify a serious underlying condition.

Before using this product, patients with pre-existing conditions such as liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or urinary difficulties due to an enlarged prostate gland should consult a healthcare professional. Additionally, those experiencing a cough with excessive phlegm or a persistent cough associated with smoking, asthma, or emphysema should seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using this product to avoid potential interactions.

Drug Interactions

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using acetaminophen. The interaction between these two medications may alter the anticoagulant effect of warfarin, potentially increasing the risk of bleeding. Monitoring of INR (International Normalized Ratio) levels is advisable to ensure safe and effective anticoagulation therapy. Adjustments to the dosage of warfarin may be necessary based on clinical judgment and laboratory results.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The medication is not recommended for children under 4 years of age. For patients aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours.

Healthcare providers should advise parents and caregivers to discontinue use and seek medical advice if symptoms worsen or persist for more than 5 days in children.

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 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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function. Regular monitoring of renal function may be warranted in these patients, although specific guidelines are not outlined.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 8 liquid caps within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also advised that patients with compromised liver function limit their alcohol intake to fewer than 3 alcoholic drinks daily while using this product. Due to the potential for increased susceptibility to acetaminophen-related hepatotoxicity, careful consideration of liver function is essential in this patient population. Regular assessment of liver function may be warranted to ensure patient safety and to mitigate the risk of severe adverse effects.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with acetaminophen, including symptoms such as 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 seek immediate medical assistance or contact a Poison Control Center in the event of an accidental overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOi) or have taken one within the past two weeks. Patients should be reminded to verify with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOi.

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 advised to seek medical advice if their symptoms worsen or persist beyond 5 days for children or 7 days for adults. If fever worsens or lasts more than 3 days, or if there is any redness or swelling, patients should also be instructed to stop use and contact a healthcare professional. New symptoms or a recurrence of cough, especially if accompanied by a rash or persistent headache, should prompt immediate consultation, as these may indicate a serious condition.

While using this product, patients must be reminded to adhere strictly to the recommended dosage and not exceed the directed amount. It is essential to encourage patients to consult a doctor before use if they have any underlying health conditions, including liver disease, heart disease, thyroid disease, diabetes, or high blood pressure. Patients experiencing difficulty urinating due to an enlarged prostate gland, or those with a cough that produces excessive phlegm, should also seek medical advice prior to use. Furthermore, patients with a persistent or chronic cough related to smoking, asthma, or emphysema should consult a healthcare provider before using this product. Lastly, patients taking the blood-thinning medication warfarin should be advised to discuss their use of this product with a doctor or pharmacist.

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, maintaining a range of 20-25°C (68-77°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 ensure the product remains effective and safe for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)