Mejoralito

Description

Temperal-ito is a pediatric formulation indicated for the management of fever in children. It is available in a 4 fluid ounce (floz) dosage form. The product is identified by the National Drug Code (NDC) 69729-068-04.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with various conditions, including sore throat, the common cold, influenza, headache, and toothache.

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

Dosage and Administration

This product is intended for use in pediatric patients and does not contain complete directions or warnings for adult use. Prior to administration, the product must be shaken well.

Dosing should be determined using the following chart, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative. The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period. Treatment should not exceed 5 consecutive days unless directed by a healthcare professional.

Dosage Chart:

• For patients weighing under 24 lb or under 2 years of age, consult a doctor for the appropriate dose.

• For patients weighing 24-35 lb and aged 2-3 years, the recommended dose is 5 mL.

• For patients weighing 36-47 lb and aged 4-5 years, the recommended dose is 7.5 mL.

• For patients weighing 48-59 lb and aged 6-8 years, the recommended dose is 10 mL.

• For patients weighing 60-71 lb and aged 9-10 years, the recommended dose is 12.5 mL.

• For patients weighing 72-95 lb and aged 11 years, the recommended dose is 15 mL.

Administration should be performed using the enclosed measuring syringe to ensure accurate dosing. It is essential to consult with a healthcare provider before administering this medication to any infant or child.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• This product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

Severe liver damage may occur in pediatric patients taking this product, which contains acetaminophen, if more than five doses are administered within a 24-hour period, or if used concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to the maximum daily dosage to mitigate the risk of liver injury.

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

Before administering this product, healthcare providers should inquire about any existing liver disease in the child. Additionally, it is essential to consult with a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant, as potential interactions may necessitate careful monitoring or alternative treatment options.

Caregivers must be cautioned against exceeding the recommended dosage, as this could lead to overdose and associated complications. If new symptoms arise, or if there is evidence of redness or swelling, worsening pain lasting more than five days, or a fever that worsens or persists beyond three days, caregivers should be instructed to discontinue use and seek medical advice. These signs may indicate a serious condition that warrants further investigation.

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. Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. It is advisable to consult a doctor or pharmacist if there is uncertainty regarding the presence of acetaminophen in other medications.

In cases where patients experience a severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, prompt medical consultation is recommended.

Patients with a history of liver disease should seek medical advice before using this product. Additionally, those taking the blood-thinning medication warfarin should consult a healthcare professional prior to use.

An overdose of this product may lead to liver damage. In the event of an overdose, it is critical to seek medical assistance or contact a Poison Control Center immediately, as timely intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to discontinue use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious condition.

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 necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients require careful consideration when administering this medication. For children under 2 years of age and weighing less than 24 pounds, it is advised to consult a doctor before use. The recommended dosages for pediatric patients based on weight and age are as follows:

• For children weighing 24-35 pounds (ages 2-3): 5 mL

• For children weighing 36-47 pounds (ages 4-5): 7.5 mL

• For children weighing 48-59 pounds (ages 6-8): 10 mL

• For children weighing 60-71 pounds (ages 9-10): 12.5 mL

• For children weighing 72-95 pounds (age 11): 15 mL

It is crucial to always check with a healthcare professional before administering this medication to infants or children.

Warnings include the risk of severe liver damage if more than 5 doses are taken within a 24-hour period, which is the maximum daily amount. Parents and caregivers should seek prompt medical attention 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.

Additionally, an overdose may lead to liver damage, and immediate medical attention is necessary for both children and adults, even if no signs or symptoms are present.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of Mejoralito (acetaminophen suspension) during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. As with any medication, the potential benefits must be weighed against any unknown risks to fetal outcomes. It is advisable for women of childbearing potential to discuss their medication use with their healthcare provider to ensure appropriate management during pregnancy.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this product to nursing mothers, as the effects on the nursing infant are not well studied.

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 necessitates careful clinical judgment.

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 to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised that a healthcare professional be consulted if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the need for any dosage adjustments or additional monitoring based on the patient's liver function status.

Overdosage

Taking more than the recommended dose of this medication may lead to serious liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the risk of liver damage increases with the amount of the drug ingested beyond the recommended dosage. Therefore, vigilance in monitoring patients who may have exceeded the dosage is essential.

In managing an overdose, it is recommended to assess the patient's clinical status and initiate appropriate supportive care. Continuous monitoring of liver function tests may be warranted, and specific treatment protocols should be followed as per established guidelines.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this medication if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the product. Healthcare providers should instruct patients to discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, or if pain worsens or persists beyond five days. Additionally, patients should be advised to stop use and consult a doctor if a fever worsens or lasts more than three days, as these may indicate a serious underlying condition.

It is also essential for healthcare providers to recommend that patients consult a doctor before using this medication if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin, to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 15° to 30°C (59° 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. Proper storage conditions are essential to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period and advise against use for more than 5 consecutive days unless directed by a healthcare professional. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Mejoralito, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)