Max Relief Junior Grape

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for use in pediatric patients, with specific caution advised for those concurrently taking the anticoagulant warfarin. Healthcare professionals should ensure that patients or caregivers consult with a doctor or pharmacist prior to administration if the child is on warfarin therapy.

It is essential to adhere to the recommended dosage guidelines when using this product, as exceeding the recommended dose may lead to adverse effects.

No teratogenic or nonteratogenic effects have been reported in relation to this drug.

Dosage and Administration

Shake the product well before use. Healthcare professionals should determine the appropriate dose based on the patient's weight whenever possible; if weight is not available, age may be used as a guide. The enclosed dosing cup, specifically designed for use with this product, must be utilized for accurate measurement.

The recommended dosing is as follows:

• For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a doctor before administration.

• For patients weighing 25 to 35 lbs or aged 2 to 3 years, the recommended dose is 1 teaspoon (5 mL).

• For patients weighing 36 to 47 lbs or aged 4 to 5 years, the recommended dose is 1 1/2 teaspoons (7.5 mL).

• For patients weighing 48 to 59 lbs or aged 6 to 8 years, the recommended dose is 2 teaspoons (10 mL).

• For patients weighing 60 to 71 lbs or aged 9 to 10 years, the recommended dose is 2 1/2 teaspoons (12.5 mL).

• For patients weighing 72 to 95 lbs or aged 11 years, the recommended dose is 3 teaspoons (15 mL).

If necessary, the dose may be repeated every 4 hours while symptoms persist; however, it is important not to exceed 5 doses within a 24-hour period.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the recommended dosage guidelines. Exceeding the recommended dose may lead to adverse effects; therefore, caution is advised to prevent potential overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the child exceeds the maximum daily dosage of 5 doses within a 24-hour period or if it is taken concurrently with other medications containing acetaminophen.

Acetaminophen has been 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 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

General precautions should be observed prior to use. It is recommended to consult a doctor or pharmacist if the child has a history of liver disease. Additionally, if the child is currently taking the anticoagulant warfarin, a healthcare professional should be consulted before use. Adherence to the recommended dosage is crucial to avoid overdose.

In the event of an overdose, immediate medical attention is necessary. Contact the Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as rapid intervention is critical.

Discontinuation of the product and consultation with a healthcare provider is warranted if pain worsens or persists beyond 5 days, if fever intensifies or lasts longer than 3 days, or if new symptoms arise, including redness or swelling, which may indicate a serious condition.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. Patients may experience severe liver damage if they exceed five doses within a 24-hour period, which is the maximum recommended daily amount, or if they take this product concurrently with other medications containing acetaminophen.

Allergic reactions, particularly severe skin reactions, have been reported. 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.

Patients should also be vigilant 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 essential to consult a healthcare professional promptly.

Additional caution is warranted if pain worsens or lasts longer than five days, or if fever intensifies or persists beyond three days. The emergence of new symptoms, or the presence of redness or swelling, may indicate a serious condition, and patients should seek medical advice in such cases.

In the event of an overdose, immediate medical help should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Quick medical attention is critical, even if no signs or symptoms are immediately apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using acetaminophen if they are concurrently taking warfarin, a blood-thinning medication. Acetaminophen may influence International Normalized Ratio (INR) levels, which could affect the efficacy and safety of warfarin therapy. Monitoring of INR levels is advised in such cases to ensure appropriate anticoagulation management.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen.

Packaging & NDC

Below are the non-prescription pack sizes of Max Relief Junior Grape (childrens acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 24 lbs (under 2 years) should consult a doctor before use. For children aged 2 to 3 years weighing 25 to 35 lbs, the recommended dosage is 1 teaspoon (5 mL). For those aged 4 to 5 years weighing 36 to 47 lbs, the dosage increases to 1 1/2 teaspoons (7.5 mL). Children aged 6 to 8 years weighing 48 to 59 lbs should receive 2 teaspoons (10 mL), while those aged 9 to 10 years weighing 60 to 71 lbs may take 2 1/2 teaspoons (12.5 mL). For children aged 11 years weighing 72 to 95 lbs, the recommended dosage is 3 teaspoons (15 mL).

Severe liver damage may occur in pediatric patients who exceed 5 doses in 24 hours, which is the maximum daily amount, or who use other medications containing acetaminophen. Acetaminophen may also cause severe skin reactions, including skin reddening, blisters, and rash; if any of these symptoms occur, use should be discontinued immediately, and medical assistance sought. Parents should be aware that if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

It is crucial to avoid using this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Consultation with a doctor or pharmacist is advised if the child has liver disease or is taking the blood-thinning medication warfarin.

In the event of an overdose, immediate medical help should be sought, or the Poison Control Center (1-800-222-1222) should be contacted, as prompt medical attention is essential even if no signs or symptoms are present. This medication should be stored out of reach of children.

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

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when prescribing this product to women of childbearing potential and consider the lack of information when assessing the potential risks and benefits for pregnant patients. It is advisable to monitor any developments in the literature regarding the use of this product in pregnancy and to counsel patients accordingly.

Lactation

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

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, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed five doses within a 24-hour period, as this represents the maximum daily amount. Additionally, patients should avoid concomitant use with other medications containing acetaminophen to prevent the risk of overdose and subsequent liver injury.

Before administration, it is advisable for caregivers to consult with a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to mitigate potential adverse effects related to compromised liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance by contacting the Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial, even in the absence of noticeable signs or symptoms. Healthcare professionals should be aware that early recognition and management of an overdose can significantly impact patient outcomes.

It is essential to monitor the patient closely for any potential symptoms that may arise following an overdose. The specific manifestations can vary depending on the substance involved and the amount ingested. Therefore, a thorough assessment and appropriate supportive care should be initiated as soon as possible.

In summary, the key steps in managing an overdose include immediate contact with poison control, vigilant monitoring for symptoms, and the provision of supportive care as necessary.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can 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 reach of children to prevent accidental ingestion. It is important to instruct patients to stop using the medication and consult a doctor if pain worsens or persists for more than 5 days, if fever intensifies or lasts longer than 3 days, or if new symptoms arise, including redness or swelling, as these may indicate a serious condition.

In the event of an overdose, patients should be informed to seek medical assistance immediately or contact the Poison Control Center at 1-800-222-1222. Quick medical attention is crucial, even if no signs or symptoms are apparent.

Healthcare providers should also recommend that patients consult a doctor or pharmacist before using this medication if the child has liver disease. Additionally, it is essential to ask about any concurrent use of the blood-thinning medication warfarin, as this may affect the safety and efficacy of the treatment. Patients must be reminded not to exceed the recommended dose, as this could lead to overdose.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, within the range of 20° to 25°C (68° to 77°F). Care must be taken to protect the product from freezing, as well as from exposure to light to ensure its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Clinicians should counsel patients to consult a doctor or pharmacist prior to use if the child has liver disease or is concurrently taking the anticoagulant warfarin.

Patients should be advised to discontinue use and seek immediate medical attention if a skin reaction occurs. Additionally, they should stop use and consult a healthcare professional if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, or if new symptoms arise.

Drug Information (PDF)

This file contains official product information for Max Relief Junior Grape, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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