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

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 crucial 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.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider 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 another medication, it is essential to consult a doctor or pharmacist. Furthermore, this product should not be administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained within.

General precautions include consulting a healthcare professional before use if the child has a history of 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 critical 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 prompt intervention is crucial, even if no symptoms are apparent.

Healthcare professionals should advise patients to discontinue use and consult a physician if pain worsens or persists beyond five days, if fever intensifies 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, which is more than 5 doses in 24 hours, is exceeded or if the product is taken 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 consult a doctor promptly if they experience a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting.

It is crucial to avoid using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should also refrain from using the product if they are unsure whether a drug contains acetaminophen or if they have a known allergy to acetaminophen or any of the inactive ingredients in the formulation.

Patients are advised to stop use and consult a doctor if pain worsens or lasts for more than 5 days, if fever worsens or lasts for more than 3 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 imperative to seek medical help or contact the Poison Control Center at 1-800-222-1222 immediately. Quick medical attention is critical, 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 interaction could potentially affect the anticoagulant's efficacy and safety profile, necessitating careful monitoring of INR levels and possible dosage adjustments of warfarin.

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 dosage is 3 teaspoons (15 mL).

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. Acetaminophen may also cause severe skin reactions, including skin reddening, blisters, and rash; if such reactions occur, use should be discontinued immediately, and medical assistance 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.

Parents should consult a doctor before use if their 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) contacted, as prompt medical attention is critical even if no signs or symptoms are present.

Storage conditions require the product to be kept at room temperature (20°-25°C or 68°-77°F), protected from freezing and light.

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 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, 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 therapies may be explored in consultation with the patient. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any plans for pregnancy or breastfeeding with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a history of liver disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment. Careful evaluation is necessary to ensure safe and effective use in this 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 patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to determine any necessary dosage adjustments or additional monitoring requirements based on the patient's specific liver function status.

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 substance involved. Continuous monitoring and supportive care may be necessary, depending on the severity of the situation. It is essential for healthcare providers to remain vigilant and proactive in addressing potential complications that may arise from an overdose scenario.

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 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 discontinue use and seek medical attention if pain worsens or persists for more than 5 days. Similarly, patients should be instructed to stop use and consult a doctor if fever intensifies or lasts longer than 3 days. It is important to inform patients that the emergence of new symptoms, or the presence of redness or swelling, may indicate a serious condition, warranting immediate medical consultation.

In the event of an overdose, healthcare providers should emphasize the importance of obtaining medical help or contacting the Poison Control Center at 1-800-222-1222 without delay. Quick medical attention is crucial, even if the patient does not exhibit any signs or symptoms of overdose.

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

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 maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with the option to repeat the dose every 4 hours as needed while symptoms persist. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period. There is no additional information available regarding laboratory tests, abuse potential, 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.

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