Revasol Nighttime Cold and Flu

Description

REVASOL NIGHTTIME is a combination product formulated for nighttime use, containing 10 mg of the active ingredient per tablet. The tablets are round, biconvex, and film-coated, exhibiting a light blue color. Inactive ingredients include microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and silicon dioxide. The SPL Code for this product is 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates sore throat, minor aches and pains, runny nose, sneezing, headache, fever, 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.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours. It is important to note that children under 12 years of age should not use this medication.

When utilizing both Day Time and Night Time products, the total number of doses should not exceed 4 doses within a 24-hour period.

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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this may lead to serious drug interactions.

• For the purpose of inducing sleepiness in children, as this is not an approved use and may pose safety risks.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. 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 taken in conjunction with other medications containing acetaminophen. Patients who consume three or more alcoholic drinks daily should be particularly cautious, as this increases the risk of liver damage.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

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

Patients should be instructed to stop use and consult a doctor if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or lasts longer than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of this product, specifically if adults and children over 12 years of age take more than 4 doses (30 mL each) within a 24-hour period, if the product is taken concurrently with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic drinks daily while using this product.

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.

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

Overdose of this product can lead to serious health complications, including liver damage. Patients who suspect an accidental overdose should seek professional medical assistance or contact a Poison Control Center without delay, as timely intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts longer than 7 days, if fever worsens or persists beyond 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 with liver disease, glaucoma, a cough accompanied by excessive phlegm, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema should consult a healthcare provider. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use. Patients taking the blood-thinning medication warfarin are also encouraged to consult a doctor or pharmacist before using this product.

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 also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it should not be administered for at least 2 weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted due to the potential for altered anticoagulant effects.

Caution is advised when this medication is used in conjunction with alcohol, sedatives, or tranquilizers, as these substances may enhance drowsiness and increase the risk of sedation-related adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Revasol Nighttime Cold and Flu (acetaminophen, dextromethorphan hbr and doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 30 mL every 6 hours. When utilizing both Day Time and Night Time products, the total dosage should not exceed 4 doses within a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in children. Caution is advised when prescribing this medication to pediatric patients.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 exercise caution 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.

• Concurrent use with other medications containing acetaminophen should be avoided to prevent exceeding the recommended dosage.

• Adults who consume 3 or more alcoholic drinks daily while using this product are at an increased risk for liver damage.

Due to the potential for serious adverse effects, it is recommended that patients with compromised liver function consult a healthcare professional prior to use. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

Overdose warning: Taking more than the recommended dose may lead to serious health complications, including potential 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.

Quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. Prompt intervention can significantly mitigate the risks associated with overdose and improve outcomes. Healthcare professionals are advised to monitor patients closely and provide appropriate management based on the severity of the overdose and the specific clinical presentation.

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

Severe skin reactions have been reported in postmarketing experience with acetaminophen, including symptoms such as skin reddening, blisters, and rash. In cases of such reactions, it is advised to discontinue use and seek medical assistance promptly.

Additionally, instances of overdose have been documented, with potential serious health consequences, including liver damage. In the event of an accidental overdose, it is crucial to seek professional help or contact a Poison Control Center immediately, as timely medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to keep this medication 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 medication in conjunction with any other drug containing 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 medication 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 for two weeks after discontinuing an MAOI. If patients are unsure whether their prescription includes an MAOI, they should seek clarification from a doctor or pharmacist.

Healthcare providers should emphasize that this medication should not be used to induce sleepiness in children. Patients must be advised to stop using the product and consult a doctor if their pain or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition.

While using this product, patients should be instructed not to exceed the recommended dosage and to avoid alcoholic beverages. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness may result. Caution should be advised when driving a motor vehicle or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients with liver disease, glaucoma, a cough associated with excessive phlegm, or chronic respiratory issues such as asthma, chronic bronchitis, or emphysema should be encouraged to consult a doctor before use. Additionally, patients experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice prior to using this medication.

Finally, patients taking the blood-thinning medication warfarin should be advised 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 Nighttime Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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