Revasol Acetaminophen Suspension Dye Free

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. These conditions include the common cold, headache, toothache, backache, premenstrual and menstrual cramps, influenza, sore throat, muscular aches, and minor pain of arthritis.

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

Dosage and Administration

Shake the product well before use. It is imperative to adhere to the recommended dosing guidelines to avoid overdose.

For children aged 2 years to under 12 years, the appropriate dose should be determined using the dosage chart below, 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 professional.

Dosage Chart for Children:

• Weight under 24 lb or age under 2 years: Consult a doctor.

• Weight 24-35 lb (2-3 years): 5 mL

• Weight 36-47 lb (4-5 years): 7.5 mL

• Weight 48-59 lb (6-8 years): 10 mL

• Weight 60-71 lb (9-10 years): 12.5 mL

• Weight 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, which can be administered by filling the dosing cup to the 10 mL line twice, every 4 hours while symptoms last. The maximum allowable dosage is 5 doses (100 mL) within a 24-hour period unless directed otherwise by a physician. Treatment duration should not exceed 10 days unless advised by a healthcare professional.

It is essential 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.

Exceeding the recommended dosage while using this product is also contraindicated, as it may lead to serious adverse effects.

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 lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and 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 is accompanied 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 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 arise; 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 who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, or if a child exceeds 5 doses in the same timeframe. The risk is further heightened when acetaminophen is taken in conjunction with other medications containing the same active ingredient or if an 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 use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

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 advice should be sought. The presence of redness or swelling may indicate a serious condition and warrants immediate attention.

Patients with liver disease should consult a doctor 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

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as concurrent use may elevate the risk of bleeding. No additional drug interactions or laboratory test interactions have been identified for this medication. Monitoring for signs of increased bleeding is advisable in patients who are co-administered warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Revasol Acetaminophen Suspension Dye Free (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 using the following weight-based chart. If weight is not available, age may be used as a guide for dosing:

• For children under 24 lbs (under 2 years), consultation with a doctor is advised.

• For children weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL.

• For children weighing 36-47 lbs (4-5 years), the recommended dose is 7.5 mL.

• For children weighing 48-59 lbs (6-8 years), the recommended dose is 10 mL.

• For children weighing 60-71 lbs (9-10 years), the recommended dose is 12.5 mL.

• For children weighing 72-85 lbs (11 years), the recommended dose is 15 mL.

Pediatric patients should not exceed 5 doses in a 24-hour period unless directed by a healthcare professional. Additionally, treatment should not extend beyond 5 days unless advised by a doctor. If pain worsens or persists for more than 5 days in children under 12 years, prompt consultation with a healthcare provider is recommended.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. 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 general considerations 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 on 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

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:

• 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 recommended that patients with compromised liver function adhere strictly to the prescribed dosage and avoid exceeding the stated limits. Regular monitoring of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

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 symptoms does not preclude the possibility of overdose effects. Therefore, vigilance and timely action are essential in managing potential overdose situations.

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

Acetaminophen has been associated with severe skin reactions in postmarketing experience. Reports indicate that symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients 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 medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be made aware that this product should not be used if they have a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Healthcare providers should instruct patients 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, patients should be advised to stop using the product and consult a doctor if their fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

It is crucial to emphasize to patients the importance of adhering to the recommended dosage and to be aware of the overdose warning associated with this product. Patients with liver disease should be advised to consult a doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should be encouraged to seek guidance from a doctor or pharmacist prior to use.

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 Dye Free, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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