Max Relief Junior

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for use in pediatric patients. Prior to administration, it is essential for healthcare professionals to inquire whether the child is concurrently taking the anticoagulant warfarin, as this may influence the safety and efficacy of the treatment.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Shake the product well before use. Healthcare professionals should determine the appropriate dose based on the patient's weight, utilizing the dosage chart provided below. If weight is not available, age may be used as a secondary reference for dosing. It is imperative to use only the enclosed dosing cup designed specifically for this product.

Dosing may be repeated every 4 hours as needed while symptoms persist. However, it is essential not to exceed 5 doses within a 24-hour period.

Dosage Chart:

• For patients weighing under 24 lbs or under 2 years of age, consult a physician for dosing recommendations.

• 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).

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dose, as this may lead to overdose. No other specific contraindications have been identified in the available data.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the child exceeds five doses within a 24-hour period, the maximum daily amount. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen.

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

Healthcare professionals should 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, prompt consultation with a physician is advised.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a doctor or pharmacist is recommended. Furthermore, this product should not be administered to children with a known allergy to acetaminophen or any of the inactive ingredients.

General precautions include consulting a healthcare provider before use if the child has liver disease. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the child is currently taking the anticoagulant warfarin. It is crucial to adhere to the recommended dosage to avoid the risk of overdose.

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

Patients should be instructed to discontinue use and contact a healthcare provider if pain worsens or persists beyond five days, if fever worsens or lasts more than three days, or if new symptoms arise, including 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 if the maximum daily amount of acetaminophen is exceeded, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen.

There is also 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 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 recommended to consult a healthcare professional promptly.

Additionally, patients are instructed to stop use and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, or if new symptoms arise, including redness or swelling, as these may indicate a serious condition.

In the case of an overdose, it is critical to seek medical help or contact the Poison Control Center at 1-800-222-1222 immediately, as prompt medical attention is essential even if no signs or symptoms are initially apparent.

Drug Interactions

Acetaminophen may interact with the anticoagulant warfarin. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to using acetaminophen if they are concurrently taking warfarin. This precaution is necessary to ensure safe and effective use, as the interaction could potentially affect the anticoagulant's efficacy and safety profile.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen. Therefore, routine monitoring or dosage adjustments are not indicated beyond the specific interaction with warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Max Relief Junior (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 those weighing 25 to 35 lbs (2 to 3 years), the recommended dosage is 1 teaspoon (5 mL). Patients weighing 36 to 47 lbs (4 to 5 years) should receive 1 1/2 teaspoons (7.5 mL), while those weighing 48 to 59 lbs (6 to 8 years) may take 2 teaspoons (10 mL). For children weighing 60 to 71 lbs (9 to 10 years), the dosage is 2 1/2 teaspoons (12.5 mL), and for those weighing 72 to 95 lbs (11 years), 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 take other medications containing acetaminophen. Acetaminophen may also cause severe skin reactions, including skin reddening, blisters, or rash; if such symptoms occur, use should be discontinued, and medical assistance sought immediately. Additionally, 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.

Parents or caregivers should consult a doctor before use 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 critical even if no signs or symptoms are observed.

Storage should be at room temperature between 20°-25°C (68°-77°F), protected from freezing and light.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any 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, healthcare professionals are advised to exercise caution when prescribing this product to pregnant patients. Due to the lack of safety concerns, dosage modifications, or special precautions outlined in the insert, the potential risks and benefits should be carefully considered on a case-by-case basis. Women of childbearing potential should be informed of the uncertainties surrounding the use of this product during pregnancy and encouraged to discuss any concerns with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation.

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 may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure appropriate management of therapy in these patients.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional, such as a doctor or pharmacist, prior to using this product, particularly if they have a history of liver disease.

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, patients should not exceed 5 doses within a 24-hour period, as this is the maximum recommended amount. Additionally, caution is advised when using this product in conjunction with other medications that also contain acetaminophen, as this may further increase the risk of liver injury.

Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and prevent potential adverse effects.

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 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 management strategies should be implemented as soon as possible to mitigate any adverse effects.

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 these contexts.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to discontinue use and seek medical attention if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three 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 instructed to obtain medical help or contact the Poison Control Center at 1-800-222-1222 immediately. It is essential to emphasize that prompt medical attention is critical, even if no signs or symptoms are apparent.

Providers should also recommend that patients consult with a doctor or pharmacist prior to use if the child has liver disease. Additionally, it is important to advise that if the child is taking the blood-thinning medication warfarin, they should seek professional guidance before using this product. Patients must be reminded not to exceed the recommended dose, as this could lead to overdose.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. 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 maintain 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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