Revasol Acetaminophen Suspension

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the relief of minor aches and pains associated with various conditions. Specifically, it is effective for alleviating discomfort due to the common cold, headache, toothache, backache, premenstrual and menstrual cramps, flu, sore throat, muscular aches, and minor pain of arthritis.

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

Dosage and Administration

Healthcare professionals should instruct patients to adhere strictly to the recommended dosage to avoid overdose. Prior to administration, the product must be shaken well.

For children aged 2 years to under 12 years, the appropriate dose should be determined using the following chart, prioritizing weight over age when possible. The child protective cap should be removed, and the dose should be squeezed into the enclosed dosing cup. Dosing may be repeated every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period unless otherwise directed by a physician. Treatment should not exceed 5 days unless advised by a healthcare provider.

Dosage Chart for Children:

• Under 24 lb (under 2 years): Consult a doctor for dosing.

• 24-35 lb (2-3 years): 5 mL

• 36-47 lb (4-5 years): 7.5 mL

• 48-59 lb (6-8 years): 10 mL

• 60-71 lb (9-10 years): 12.5 mL

• 72-85 lb (11 years): 15 mL

• *Or as directed by a doctor.

For adults and children aged 12 years and over, the recommended dose is 20 mL (equivalent to two 10 mL doses) every 4 hours while symptoms last. The dosing cup should be filled to the 10 mL line twice for accurate dosing. Patients should not exceed 5 doses (100 mL) in a 24-hour period unless directed by a physician, and treatment should not continue for more than 10 days without medical advice.

It is imperative to use only the enclosed dosing cup specifically designed for this product; no other dosing devices should be utilized.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other medication 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.

Additionally, this product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period; if a child exceeds 5 doses in 24 hours, which is the maximum daily amount; if it is taken concurrently with other medications containing acetaminophen; or if an adult consumes three or more alcoholic beverages daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions include advising patients to seek medical advice prior to use if they have a history of liver disease. Additionally, it is recommended that patients consult a doctor or pharmacist before using this product if they are concurrently taking the anticoagulant medication warfarin.

Patients should be instructed to stop taking the product and contact their healthcare provider if any of the following occur: pain worsens or persists for more than 10 days in adults; pain worsens or lasts more than 5 days in children under 12 years; fever worsens or lasts more than 3 days; new symptoms develop; or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosage. Specifically, adults should not take more than 4,000 mg of acetaminophen in a 24-hour period, and children should not exceed 5 doses within the same timeframe, which is the maximum daily amount. The risk of liver damage is further increased if acetaminophen is taken in conjunction with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

A sore throat warning is also applicable; if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

In cases of overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no symptoms are initially apparent.

Patients are advised to stop use and consult a doctor if pain worsens or lasts more than 10 days in adults, or if pain persists for more than 5 days in children under 12 years. Additionally, if fever worsens or lasts more than 3 days, or if new symptoms arise, medical consultation is recommended. Redness or swelling may also indicate a serious condition, warranting immediate medical attention.

Patients with liver disease should consult a healthcare provider before using this product. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

Acetaminophen has been observed to enhance the anticoagulant effect of warfarin, which may lead to an increased risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients who are receiving both acetaminophen and warfarin concurrently to ensure safe and effective management of anticoagulation therapy.

No additional drug interactions or interactions with laboratory tests have been reported.

Packaging & NDC

Below are the non-prescription pack sizes of Revasol Acetaminophen Suspension (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years to under 12 years should have their dosage determined based on weight whenever possible; otherwise, age may be used as a guide. The recommended dosages are as follows: for children weighing under 24 lbs (under 2 years), consultation with a doctor is advised. For those weighing 24-35 lbs (2-3 years), the dose is 5 mL; for 36-47 lbs (4-5 years), 7.5 mL; for 48-59 lbs (6-8 years), 10 mL; for 60-71 lbs (9-10 years), 12.5 mL; and for 72-85 lbs (11 years), 15 mL.

It is important to note that pediatric patients should not exceed 5 doses (100 mL) within a 24-hour period unless directed by a healthcare professional. Additionally, the medication should not be used for more than 5 consecutive days unless advised by a doctor. If pain worsens or persists for more than 5 days in children under 12 years, the use of the medication should be discontinued, and a doctor should be consulted.

Geriatric Use

Elderly patients should exercise caution when using this medication, particularly those aged 65 and older. It is advisable for these patients to consult a healthcare provider prior to use, especially if they have a history of liver disease. Additionally, geriatric patients who are concurrently taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before initiating treatment.

For adults and children aged 12 years and older, the recommended dosage is 20 mL (equivalent to two 10 mL doses) every 4 hours as needed for symptom relief. It is important to note that the maximum dosage should not exceed 5 doses (100 mL) within a 24-hour period unless specifically directed by a healthcare professional. Furthermore, this medication should not be used for more than 10 consecutive days unless advised by a doctor.

In the event of an overdose, prompt medical attention is crucial for both elderly patients and children, even if no immediate signs or symptoms are apparent. Monitoring and adherence to the recommended dosing guidelines are essential to ensure the safety and efficacy of the treatment in geriatric populations.

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 the safety of both the mother and the developing fetus.

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

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. Severe liver damage may occur if the following conditions are met:

• An adult consumes more than 4,000 mg of acetaminophen within a 24-hour period.

• A child exceeds 5 doses in a 24-hour period, which is the maximum daily amount.

• The product is taken concurrently with other medications that contain acetaminophen.

• An adult consumes 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver damage, it is advisable for healthcare providers to assess liver function and consider dosage adjustments or alternative therapies for patients with compromised liver function. Regular monitoring of liver enzymes may be warranted to ensure patient safety.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, regardless of whether any symptoms are apparent.

Healthcare professionals should be aware that the absence of noticeable symptoms does not preclude the possibility of serious complications. Therefore, vigilance and timely action are essential in managing potential overdose situations.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, there are no details provided concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

Patient Counseling

Patients should be advised to keep this medication out of the reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should be encouraged to consult with a healthcare professional, such as a doctor or pharmacist.

Patients should be cautioned against using this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. They should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days in adults, or for more than 5 days in children under 12 years of age. Additionally, if a fever worsens or lasts more than 3 days, or if new symptoms arise, patients should be advised to stop using the product and consult a healthcare provider.

Patients should also be informed to stop use and seek medical attention if they notice any redness or swelling, as these may indicate a serious condition. It is crucial to emphasize the importance of adhering to the recommended dosage and to be aware of the overdose warning associated with this product.

Before using this medication, patients with liver disease should be advised to consult their doctor. Furthermore, those taking the blood-thinning medication warfarin should be encouraged to speak with their doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

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 a temperature range of 15-30°C (59-86°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed safety seal is torn, broken, or missing, as this may indicate potential compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial for ensuring the product's quality and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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