Daytime 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 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 specified warnings. The recommended dosage for adults and children aged 12 years and older is 2 soft gels taken orally with water every 4 hours. It is important not to exceed 4 doses within a 24-hour period.

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.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other products containing Acetaminophen, whether prescription or nonprescription, is prohibited due to the risk of acetaminophen overdose. Patients should consult a healthcare professional if uncertain about the presence of acetaminophen in other medications.

The product should not be used in conjunction with prescription Monoamine Oxidase Inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should verify with a healthcare provider if they are unsure whether their prescription includes an MAOI.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that exceeding 4 doses within a 24-hour period—this being the maximum daily amount—or concurrent use with other medications containing acetaminophen, as well as the consumption of 3 or more alcoholic drinks daily while using this product, significantly increases the risk of liver injury.

Acetaminophen may also provoke severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider without delay.

Patients should be instructed to stop taking the product and contact their doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms worsen or persist beyond 5 days in children or 7 days in adults, or if fever intensifies or lasts more than 3 days, medical consultation is warranted. The presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or persistent headache may indicate a serious condition, necessitating prompt medical evaluation.

In the event of an overdose, immediate medical attention should be sought, or the local Poison Control Center should be contacted.

No specific laboratory tests are recommended for the safe use of this product.

Side Effects

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

Severe liver damage may occur with the use of this product, particularly if patients exceed the maximum daily dosage of four doses within a 24-hour period, take it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they consult a healthcare professional promptly.

Other adverse reactions that warrant discontinuation of use and consultation with a doctor include the onset of nervousness, dizziness, or sleeplessness, worsening symptoms that last beyond five days in children or seven days in adults, fever that worsens or lasts more than three days, 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 expected. These symptoms may indicate a serious underlying condition that requires medical evaluation.

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 Cold/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 product is not recommended for children under 4 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is 2 soft gels taken with water every 4 hours.

In pediatric patients, if symptoms worsen or persist for more than 5 days, or if fever lasts more than 3 days, it is advised to discontinue use and seek medical advice.

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 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 4 doses within a 24-hour period to prevent severe liver damage. Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen, as this may increase the risk of hepatotoxicity.

Furthermore, patients with compromised liver function should limit their alcohol intake to fewer than 3 alcoholic drinks per day while using this product, as excessive alcohol consumption can exacerbate the risk of liver injury. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control center without delay. Prompt medical intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has indicated that acetaminophen may be associated with severe skin reactions. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that users discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients must be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is crucial to inform patients that they should not use this product if they are currently taking a prescription Monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI drug within the past two weeks. Patients who are unsure if their prescription medication contains an MAOI should be encouraged to ask their healthcare provider or pharmacist.

Patients should be instructed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if their symptoms worsen or persist beyond 5 days for children or 7 days for adults. If a fever worsens or lasts more than 3 days, or if there is any redness or swelling, patients should also stop use and contact a healthcare professional.

Patients should be made aware that new symptoms or a recurrence of cough, especially if accompanied by a rash or persistent headache, may indicate a serious condition, and they should seek medical attention promptly. It is important to emphasize that patients should not exceed the recommended dosage when using this product.

Before using this medication, patients should be advised to consult a doctor if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm or chronic conditions such as smoking, asthma, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should also seek guidance from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, ideally between 20-25º C (68-77º F). Care should be taken to avoid exposure to excessive heat to maintain product integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)