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. 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

Healthcare professionals should instruct patients to shake the product well before use. The enclosed dosing cup, specifically designed for this product, must be utilized for accurate dosing.

Dosing should be determined primarily by the patient's weight; however, if weight is not available, age may be used as a secondary guide. The following dosage chart provides the recommended doses:

• 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 also 2 1/2 teaspoons (12.5 mL).

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

Contraindications

Use is contraindicated in patients with liver disease due to the potential for exacerbating hepatic impairment. Additionally, the recommended dosage should not be exceeded in patients concurrently taking the anticoagulant warfarin, as this may increase the risk of bleeding complications.

Patients should discontinue 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, including redness or swelling, which may indicate a serious underlying condition.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the child exceeds the maximum daily amount 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 is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional without delay.

Healthcare professionals should advise caregivers to consult a doctor or pharmacist prior to use if the child has a history of liver disease. Additionally, it is crucial to seek guidance if the child is currently taking the anticoagulant warfarin, as the use of this product may necessitate careful monitoring of dosage to avoid potential overdose.

In the event of an overdose, immediate medical attention is required. Caregivers should contact the Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is critical, even if no symptoms are initially apparent.

Caregivers should also be instructed to discontinue use and consult a healthcare provider if the child experiences worsening pain lasting more than 5 days, a fever that worsens or persists for more than 3 days, or the emergence of new symptoms, redness, or swelling, as these may indicate a serious underlying 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. Patients with pre-existing liver disease should consult a healthcare professional before use.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Patients should stop using the product and seek medical advice 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 event of an overdose, it is critical to obtain medical help or contact the Poison Control Center at 1-800-222-1222 immediately, even if no signs or symptoms are present, as prompt medical attention is essential.

Patients taking the blood-thinning medication warfarin or those with liver disease should consult a doctor or pharmacist before using this product. It is imperative to adhere to the recommended dosage to avoid the risk of overdose.

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 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 aforementioned consideration with warfarin.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to 3 years, the recommended dosage is 1 teaspoon (5 mL); for those aged 4 to 5 years, 1 1/2 teaspoons (7.5 mL); for ages 6 to 8 years, 2 teaspoons (10 mL); and for children aged 9 to 10 years, 2 1/2 teaspoons (12.5 mL). Children aged 11 years should also receive 2 1/2 teaspoons (12.5 mL). The maximum daily dosage should not exceed 5 doses within a 24-hour period.

Safety concerns include the risk of severe liver damage if the child exceeds the recommended doses or concurrently uses other medications containing acetaminophen. There is also an allergy alert, as acetaminophen may lead to severe skin reactions, including reddening, blisters, and rash. In the event of a skin reaction, use should be discontinued immediately, and medical assistance should be sought. 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.

Special precautions are advised for pediatric patients with liver disease, and consultation with a doctor or pharmacist is recommended if the child is taking the blood-thinning medication warfarin.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. It is important to note that the product is primarily indicated for children and lacks comprehensive directions or warnings for adult populations, including those aged 65 and older.

Healthcare providers should exercise caution when considering this product for geriatric patients, as the absence of data may limit the understanding of its safety and efficacy in this demographic. Monitoring for potential adverse effects and evaluating the necessity of dosage adjustments based on individual patient factors is recommended.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy, including safety concerns, dosage modifications, or special precautions. Therefore, healthcare professionals are advised to exercise caution when prescribing this product to pregnant patients. The potential risks and benefits should be carefully considered, and alternative treatments may be warranted based on individual patient circumstances. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

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. It is recommended to monitor the infant for any adverse effects if the nursing mother takes this medication.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 administration, it is advisable for caregivers to consult with a healthcare professional if the child has a history of liver disease. This precaution is essential to ensure the safe use of the product and to determine any necessary adjustments in dosage or monitoring requirements based on the patient's liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact the Poison Control Center at 1-800-222-1222 without delay. Prompt medical intervention is crucial, even in the absence of noticeable signs or symptoms of overdose.

The management of an overdose should be guided by the clinical presentation and the specific circumstances surrounding the incident. Continuous monitoring and supportive care may be necessary, depending on the severity of the symptoms exhibited by the patient. It is essential to remain vigilant for any potential manifestations of toxicity, as these may not be immediately apparent.

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 compound in these areas.

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 seek immediate medical assistance or contact the Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important to emphasize that prompt medical attention is crucial, even if the patient does not exhibit any signs or symptoms of overdose.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience any of the following: worsening pain that persists for more than 5 days, a fever that worsens or lasts longer than 3 days, or the emergence of new symptoms, redness, or swelling. These may indicate a serious underlying condition that requires further evaluation.

Additionally, healthcare providers should remind patients to consult with a doctor or pharmacist prior to use if the child has liver disease. It is also essential to inquire about any concurrent use of blood-thinning medications, such as warfarin, as this may affect the safety and efficacy of the product. Patients must be cautioned against exceeding the recommended dose, as this could lead to overdose and associated risks.

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 light exposure to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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.

View product document (PDF)