Max Relief Junior

Description

No description information is available for the 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, including the common cold, influenza, headache, sore throat, and toothache.

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

Dosage and Administration

Shake the product well before use. Administer the medication using only the enclosed dosing cup specifically designed for this product; do not utilize any other dosing device.

For patients weighing under 24 lbs and under 2 years of age, it is advised to consult a doctor for the appropriate dose. For patients weighing between 24 to 35 lbs and aged 2 to 3 years, the recommended dose is 1 teaspoon (5 mL). For those weighing 36 to 47 lbs and aged 4 to 5 years, the dose is 1 ½ teaspoons (7.5 mL). For patients weighing 48 to 59 lbs and aged 6 to 8 years, the dose is 2 teaspoons (10 mL). For individuals weighing 60 to 71 lbs and aged 9 to 10 years, the recommended dose is 2 ½ teaspoons (12.5 mL). Finally, for patients weighing between 72 to 95 lbs and aged 11 years, the dose is 3 teaspoons (15 mL).

If necessary, the dose may be repeated every 4 hours while symptoms persist. However, do not exceed 5 doses within a 24-hour period. Continuous administration beyond 5 days should only occur under the direction of a healthcare professional.

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within a 24-hour period or if used concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to monitor the total daily intake of acetaminophen from all sources to prevent potential toxicity.

Acetaminophen has been associated with severe skin reactions; therefore, an allergy alert is warranted. Healthcare providers should educate patients and caregivers about the signs of such reactions and the importance of discontinuing use immediately if they occur.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly. This may indicate a more serious underlying condition that requires further evaluation.

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, it is advisable to consult a healthcare professional.

Before administering this product, healthcare providers should inquire about any existing liver disease in the child. Additionally, caution is advised when this product is used in children who are concurrently taking warfarin, a blood-thinning medication. Consultation with a healthcare professional is recommended in such cases.

During the use of this product, it is critical to adhere to the recommended dosage guidelines. Exceeding the recommended dose can lead to serious health risks, including overdose.

Healthcare professionals should instruct caregivers to discontinue use and seek medical advice if any of the following occur: pain worsens or persists beyond 5 days, fever worsens or lasts more than 3 days, new symptoms develop, or if redness or swelling is observed. These symptoms may indicate a serious condition that necessitates further medical assessment.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use it concurrently with other medications containing acetaminophen. Patients should be aware of the potential for severe skin reactions associated with acetaminophen use, indicating a need for caution.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly. It is contraindicated to use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients should seek guidance from a doctor or pharmacist.

Patients with liver disease should consult a healthcare provider before using this product. Additionally, those taking the blood-thinning medication warfarin are advised to discuss their use of this product with a doctor or pharmacist prior to administration.

While using this product, patients must adhere to the recommended dosage and should not exceed it. They should discontinue use and consult a healthcare professional if pain worsens or persists beyond five days, if fever worsens 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.

Drug Interactions

Acetaminophen may interact with the anticoagulant effects of 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. Monitoring of coagulation parameters may be warranted to ensure therapeutic efficacy and safety.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 to 11 years may receive dosing based on weight. The following dosing chart is applicable:

• Under 24 lbs (Under 2 years): Consult a doctor.

• 24 to 35 lbs (2 to 3 years): 1 teaspoon (5 mL).

• 36 to 47 lbs (4 to 5 years): 1 1/2 teaspoons (7.5 mL).

• 48 to 59 lbs (6 to 8 years): 2 teaspoons (10 mL).

• 60 to 71 lbs (9 to 10 years): 2 1/2 teaspoons (12.5 mL).

• 72 to 95 lbs (11 years): 3 teaspoons (15 mL).

Healthcare professionals should be aware of the following safety considerations:

• Severe liver damage may occur if a child takes more than 5 doses in 24 hours, which is the maximum daily amount, or if used concurrently with other medications containing acetaminophen.

• Consultation with a doctor is advised if the child has liver disease or is taking the anticoagulant warfarin.

• It is crucial not to exceed the recommended dose, and an overdose warning is in place.

Parents or caregivers should be instructed to stop use and consult a doctor if any of the following occur: pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Geriatric Use

Elderly patients have not been specifically studied in relation to the use of this product, and no specific information regarding geriatric use is provided in the prescribing information. The product is indicated for pediatric patients aged 2 to 11 years, and there are no dosage adjustments or safety concerns outlined for elderly patients.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, given the lack of data on its safety and efficacy in this population. Monitoring for potential adverse effects may be warranted, as the absence of specific geriatric data necessitates a careful assessment of individual patient needs and responses.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 initiating treatment, it is advisable for patients with liver disease to consult a healthcare professional. This precaution is essential to ensure the safe use of the product and to evaluate the potential need for dosage adjustments or alternative therapies based on the severity of hepatic impairment. Regular monitoring of liver function may be warranted in these patients to detect any signs of hepatotoxicity early.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage, particularly in pediatric patients. Administration of more than five doses within a 24-hour period exceeds the maximum recommended daily amount and significantly increases the risk of hepatotoxicity.

Healthcare professionals are advised to strictly adhere to the recommended dosing guidelines to prevent overdosage. It is imperative to monitor patients closely for any signs of liver impairment, especially in instances where the maximum daily dose has been exceeded.

In the event of suspected overdosage, immediate medical evaluation is warranted. Management may include supportive care and monitoring of liver function tests. Prompt intervention is essential to mitigate the risk of serious complications associated with liver damage.

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

Acetaminophen has been associated with reports of severe skin reactions in the postmarketing setting. These events have been documented through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

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 15°C to 30°C (59°F to 86°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

Patients should be advised that the medication is administered orally and may be repeated every 4 hours as needed while symptoms persist. However, it should not be taken more than 5 times within a 24-hour period or for more than 5 consecutive days unless directed by a healthcare professional.

Clinicians should counsel patients to keep the medication out of reach of children. Pregnant or breastfeeding patients should consult a healthcare professional prior to use. Patients are also instructed to discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

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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