Revasol Daytime Cold and Flu

Description

Revasol Cold Daytime is identified by the SPL Code 34089-3. This formulation is designed for daytime relief from cold symptoms. The product's specific characteristics and composition details are encapsulated in its labeling, ensuring clarity for healthcare professionals.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates 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

Patients should take the medication only as directed, adhering to the overdose warning. It is essential to measure the dosage using the dosing cup provided with the product, and to keep this dosing cup with the product at all times. The dosage is specified in milliliters (mL), and patients must not exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. The use of this medication is not recommended for children under 12 years of age.

When utilizing both Day Time and Night Time products, it is crucial to carefully read each label to ensure accurate dosing.

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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions.

• History of allergic reaction to this product or any of its ingredients, which may result in severe hypersensitivity reactions.

Additionally, while using this product, it is advised to avoid exceeding the recommended dosage and to refrain from consuming alcoholic beverages.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage under certain conditions. Healthcare professionals should advise patients that adults and children over 12 years of age must not exceed 4 doses (30 mL each) within a 24-hour period, as this represents the maximum daily amount. Additionally, caution is warranted when this product is used in conjunction with other medications containing acetaminophen. Patients who consume three or more alcoholic drinks daily while using this product are also at increased risk for liver damage.

Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare provider promptly.

Patients should be advised to stop use and contact a doctor if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 5 days in children or 7 days in adults; fever that worsens or lasts more than 3 days; presence of redness or swelling; emergence of new symptoms; or a cough that recurs or occurs alongside a rash or headache lasting. These symptoms may indicate a serious underlying condition.

Emergency medical help should be sought if any severe adverse reactions occur.

Side Effects

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

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if adults and children over 12 years of age take more than 4 doses (30 mL each) within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 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. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance immediately.

Patients should also be cautious if experiencing a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, as these symptoms warrant prompt consultation with a healthcare provider.

In cases of overdose, which may lead to serious health complications including liver damage, it is critical for patients to seek professional assistance or contact a Poison Control Center immediately, even if no signs or symptoms are present. Quick medical attention is essential for both adults and children.

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have a history of liver disease, heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should seek advice from a doctor or pharmacist if they are taking the blood-thinning medication warfarin.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for the treatment of depression, psychiatric disorders, or Parkinson’s disease, as well as for a period of two weeks following the discontinuation of an MAOI. The combination may lead to serious and potentially life-threatening interactions.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential alterations in the anticoagulant effect.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. There are no established safety or efficacy profiles for pediatric patients in this age group, and caution is advised when considering treatment options for younger populations.

Geriatric Use

Elderly patients may not have specific geriatric use information available in the prescribing information. The absence of recommended age considerations, dosage adjustments, safety concerns, or special precautions indicates that the data does not highlight any particular risks or modifications for this population.

Healthcare providers should remain vigilant when prescribing this medication to geriatric patients, as individual responses may vary. Continuous monitoring and clinical judgment are advised to ensure the safe and effective use of the medication in elderly individuals.

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 available data 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 information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if the following conditions are met:

• Adults and children over 12 years of age should not exceed 4 doses (30 mL each) within a 24-hour period, as this represents the maximum daily amount for this product.

• Caution is advised when this product is taken concurrently with other medications containing acetaminophen, as this may increase the risk of liver damage.

• Patients who consume 3 or more alcoholic drinks daily should avoid using this product, as alcohol consumption can exacerbate the risk of severe liver injury.

Due to the potential for significant hepatic effects, it is recommended that healthcare providers assess liver function and consider dosage adjustments or alternative therapies for patients with compromised liver function. Regular monitoring of liver enzymes may be warranted in these patients to ensure safety and efficacy.

Overdosage

Taking more than the recommended dose of this medication may lead to serious health complications, particularly liver damage. In the event of an accidental overdose, it is imperative to seek professional medical assistance or contact a Poison Control Center without delay.

Recommended Actions

Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Healthcare professionals should be prepared to provide immediate care and support to mitigate potential health risks associated with the overdose.

Potential Symptoms

While specific symptoms of overdose may vary, the risk of severe health issues underscores the importance of vigilance and rapid response in suspected cases of overdose.

In summary, adherence to recommended dosing guidelines is essential to prevent the serious consequences associated with overdose.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in nonclinical toxicology studies. Additionally, no data has been provided concerning 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 include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately and medical assistance be sought.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children. Patients who are pregnant or breastfeeding should be encouraged to consult a health professional before using the product.

It is important to inform patients not to use this product in conjunction with any other medication that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be instructed to consult a doctor or pharmacist.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson’s disease, or if they have stopped taking an MAOI within the past two weeks. If patients are unsure whether their prescription medication contains an MAOI, they should seek guidance from a doctor or pharmacist.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised not to use it. They should also be instructed to stop use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Healthcare providers should inform patients to discontinue use and seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults. Additionally, patients should be advised to stop use and consult a doctor if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. Patients should also be made aware that a returning cough or one that occurs with a rash or persistent headache may indicate a serious condition, warranting immediate medical attention.

When using this product, patients should be reminded not to exceed the recommended dosage and to avoid consuming alcoholic beverages.

Patients with liver disease, heart disease, high blood pressure, diabetes, thyroid disease, or those experiencing difficulty urinating due to an enlarged prostate gland should be advised to consult a doctor before use. Additionally, patients with a cough that produces excessive phlegm or a chronic cough associated with smoking, asthma, or emphysema should seek medical advice prior to using this product.

Finally, patients taking the blood-thinning medication warfarin should be instructed to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, within the range of 15-30°C (59-86°F). Refrigeration is not recommended, as it may compromise the integrity of the product.

Healthcare professionals should ensure that the printed safety seal remains intact; the product should not be used if the seal is torn, broken, or missing. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)