Resfriol-Ito Children

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, toothache, flu, sore throat, and the common cold. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

This product is intended for use in accordance with the dosing chart provided. Healthcare professionals are advised to determine the appropriate dose based on the patient's weight; if weight is not available, age may be used as a secondary reference.

Tablets should be chewed or crushed completely before swallowing; they must not be swallowed whole. Dosing may be repeated every 4 hours as needed while symptoms persist. However, it is imperative not to exceed 5 doses within a 24-hour period. Additionally, the product should not be administered for more than 5 consecutive days unless specifically directed by a physician.

It is essential to adhere strictly to these guidelines to ensure safe and effective use of the product.

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.

• In children with a known allergy to acetaminophen or any inactive ingredients present in this formulation.

• In patients with liver disease; consultation with a healthcare professional is advised prior to use.

• In children concurrently taking the anticoagulant warfarin; a healthcare professional should be consulted before use.

Warnings and Precautions

Severe liver damage may occur in children who exceed five doses of this product within a 24-hour period, which is the maximum recommended daily amount. Additionally, the risk of severe liver damage increases if this product is taken concurrently with other medications containing acetaminophen.

Acetaminophen is associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should inquire about the presence of liver disease before recommending this product for use in children. Furthermore, it is essential to consult a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Contacting a Poison Control Center is recommended, as timely intervention is vital for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be advised to discontinue use and consult a healthcare provider if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

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 maximum daily dosage of acetaminophen, which is five doses within a 24-hour period, or who take this product concurrently with other medications containing acetaminophen.

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. In the event of a skin reaction, 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.

Patients are advised to stop using the product and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if new symptoms arise, or if there is any redness or swelling present, as these may indicate a serious condition.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may necessitate careful monitoring due to potential interactions that could affect coagulation parameters.

Additionally, it is advised that this medication not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related adverse effects, particularly hepatotoxicity.

Currently, there are no specific drug interactions or laboratory test interactions reported for this medication. However, ongoing monitoring and consultation with healthcare providers are recommended to ensure safe and effective use.

Packaging & NDC

Below are the non-prescription pack sizes of Resfriol-Ito Children (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 11 years are recommended to use this medication, which contains acetaminophen at a dosage of 160 mg per chewable tablet. Dosing should ideally be based on the child's weight; if weight is not available, age may be used as a guide. It is critical not to exceed 5 doses within a 24-hour period and to limit use to no more than 5 consecutive days unless directed by a healthcare professional.

Healthcare providers should be aware of the potential for severe liver damage if the recommended dosage is exceeded or if the patient is concurrently using other medications containing acetaminophen. Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash.

Parents and caregivers should consult a doctor if the child experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting. It is also advisable to seek medical advice before administering this medication to children with liver disease or those taking the anticoagulant warfarin. As with all medications, it is essential to keep this product out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

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

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus. Use of this product should be approached with caution, and dosage adjustments may be necessary based on individual circumstances. It is important for healthcare providers to monitor for any adverse effects in pregnant patients and to report these effects immediately.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of this product on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

Overdosage

In the event of an 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, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of 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 other medications, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if the child's pain worsens or persists for more than five days, or if a fever worsens or lasts longer than three days. Additionally, patients should be advised to stop use and consult a doctor if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition.

It is essential to emphasize the importance of adhering to the recommended dosage and not exceeding it while using this product. Healthcare providers should also recommend that patients consult a doctor before use if their child has liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in tamper-evident packaging. Healthcare professionals should ensure that the outer package remains unopened and that the blister is intact before use.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is essential to avoid high humidity during storage.

For reference, the expiration date and lot number can be found on the packaging flap.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Resfriol-Ito Children, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)