Max Relief Junior Grape

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Currently, there are no detailed indications or usage specifications provided. Healthcare professionals are advised to refer to the latest clinical data and guidelines for appropriate prescribing information. There are no known teratogenic or nonteratogenic effects associated with 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 intervals allow for the administration of a repeat dose every 4 hours as needed, while symptoms persist. However, it is imperative not to exceed 5 doses within a 24-hour period.

Dosage Chart:

• For patients weighing under 24 lbs or under 2 years of age, consultation with a physician is advised.

• 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

There are no specified contraindications for this product. However, it is advised that the recommended dose not be exceeded, as doing so may lead to potential overdose.

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 lead to 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 if the child has a known allergy to acetaminophen or any of the inactive ingredients.

General precautions include consulting a healthcare professional 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. 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, as rapid intervention is critical, 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 it is taken concurrently with other medications containing acetaminophen. Patients should also be alerted to the risk of severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, patients should be cautious if experiencing a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these symptoms warrant prompt consultation with a healthcare provider.

Patients are advised against using this product in conjunction with any other drug 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. This product should not be used by individuals who are allergic to acetaminophen or any of the inactive ingredients contained within.

Patients should stop using the product and consult a doctor if pain worsens or lasts longer than 5 days, if fever worsens or persists for more 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, it is crucial 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

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose and associated hepatotoxicity is heightened when multiple sources of acetaminophen are used simultaneously. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

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 those weighing 25 to 35 lbs (ages 2 to 3 years), the recommended dosage is 1 teaspoon (5 mL). Children weighing 36 to 47 lbs (ages 4 to 5 years) may receive 1 1/2 teaspoons (7.5 mL), while those weighing 48 to 59 lbs (ages 6 to 8 years) can take 2 teaspoons (10 mL). For children weighing 60 to 71 lbs (ages 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).

Healthcare professionals should be aware of several warnings associated with use in pediatric patients. Severe liver damage may occur if a child takes more than 5 doses in 24 hours, which is the maximum daily amount. Acetaminophen may also cause severe skin reactions, including skin reddening, blisters, and rash; if such reactions occur, use should be discontinued, and medical help sought immediately. Additionally, if a child experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

It is advised to 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 assistance should be sought, or the Poison Control Center (1-800-222-1222) contacted, as prompt attention is critical even if no signs or symptoms are present.

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

Geriatric Use

Elderly patients should consult a healthcare professional prior to using this medication if they have a history of liver disease. Additionally, it is important for geriatric patients to seek advice from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin. These considerations are crucial to ensure safety and efficacy in this population, as age-related physiological changes may affect drug metabolism and interaction profiles. Monitoring for potential adverse effects and necessary dose adjustments may be warranted in elderly patients, particularly those with underlying health conditions or those on multiple medications.

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 concerns with their healthcare provider.

Lactation

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

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 patient safety.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if the patient exceeds the maximum daily amount of five doses within a 24-hour period. Additionally, caution is advised if the patient is taking other medications that also contain acetaminophen, as this may further increase the risk of liver damage.

It is essential for patients with liver disease to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product. This consultation is crucial to ensure safe usage 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 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 management strategies should be implemented as soon as possible to mitigate any adverse effects.

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 the medication out of reach of children to prevent accidental ingestion. Patients should be instructed to stop using the medication and consult a doctor if their pain worsens or persists for more than five days, if their fever worsens 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 must seek immediate medical assistance or contact the Poison Control Center at 1-800-222-1222. It is crucial to obtain prompt medical attention, even if no signs or symptoms of overdose are apparent.

Healthcare providers should also recommend that patients consult a doctor or pharmacist before using the medication if the child has liver disease. Additionally, it is important to inquire whether the child is taking the blood-thinning medication warfarin, as this may affect the safety of using the product. Patients should be reminded not to exceed the recommended dose, as indicated in the overdose warning.

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 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.

No additional information is 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.

View product document (PDF)