Acetaminophen, Mejoralito, Temp X

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 the common cold, headache, flu, sore throat, 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 specific dosing instructions must be followed to ensure safety and efficacy. Prior to administration, the product should be shaken well.

Dosing should be determined based on the patient's weight whenever possible; if weight is not available, age may be used as a guide. The enclosed measuring syringe must be utilized for accurate dosing.

For patients weighing under 24 pounds and under 2 years of age, it is recommended to consult a physician for appropriate dosing. For patients weighing between 24 and 35 pounds, aged 2 to 3 years, the recommended dose is 5 mL.

Doses may be repeated every 4 hours as needed while symptoms persist, but it is imperative not to exceed 5 doses within a 24-hour period. Care should be taken to adhere to these guidelines to avoid the risk of overdose.

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 children who take more than 5 doses of this product containing acetaminophen within a 24-hour period, which is the maximum recommended daily amount. Additionally, caution is advised when administering this product alongside other medications that contain acetaminophen.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blistering, 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 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare professional is recommended.

Healthcare professionals should inquire about the presence of liver disease before recommending this product for use in children. Furthermore, it is advisable to consult a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin.

Patients should be instructed to discontinue use and contact a healthcare provider if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Severe liver damage is a significant concern associated with the use of this product, particularly if patients exceed the maximum daily dosage of five doses within a 24-hour period or if they concurrently use other medications containing acetaminophen. Patients with pre-existing liver disease should consult a healthcare professional before using this product.

Allergic reactions may occur, with severe skin reactions being a notable risk. Symptoms of such reactions can include skin reddening, blistering, and rash. If any of these symptoms manifest, 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 are also cautioned against using this product in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription. Those with known allergies to acetaminophen or any inactive ingredients in this product should refrain from its use.

Additionally, patients taking the blood-thinning medication warfarin should seek advice from a healthcare provider before using this product.

Overdose is another critical concern, as taking more than the recommended dose can lead to liver damage. In the event of an overdose, immediate medical attention is essential, and patients should contact a Poison Control Center without delay.

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

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or non-prescription, is contraindicated. Patients should be advised to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

In pediatric patients, it is essential to seek medical advice prior to using this medication if the child is concurrently taking warfarin, a blood-thinning agent, due to potential interactions that may affect coagulation parameters.

Additionally, caution is warranted in patients with liver disease. It is recommended that a healthcare provider be consulted before the use of this medication in such cases to ensure safety and appropriate monitoring.

Packaging & NDC

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

Pediatric Use

Severe liver damage may occur in pediatric patients if more than 5 doses are taken within 24 hours, which is the maximum daily amount, or if used concurrently with other medications containing acetaminophen. Acetaminophen can also cause severe skin reactions, including symptoms such as skin reddening, blistering, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought.

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 important to consult a healthcare professional promptly. The medication should not be administered to children who are allergic to acetaminophen or any of the inactive ingredients in the product.

Before use, it is advisable to consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin. Dosage should be carefully followed, with the recommendation to use weight for dosing when possible; otherwise, age may be used. The enclosed measuring syringe should be utilized for accurate dosing. Doses may be repeated every 4 hours while symptoms persist, but should not exceed 5 doses in a 24-hour period.

For dosing guidance:

• For children under 24 lbs or under 2 years of age, consult a doctor.

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

An overdose may lead to liver damage, and in such cases, immediate medical help or contact with a Poison Control Center is critical, even if no signs or symptoms are apparent. It is essential to keep this medication out of reach of children.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of this drug 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. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There is no specific information available regarding the excretion of this medication in breast milk or the potential risks to breastfed infants. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on nursing infants are not well characterized.

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, 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 potential need for dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should be aware that immediate medical intervention is essential for both adults and children, regardless of the presence of symptoms.

Recommended Actions In cases of suspected overdose, it is imperative to seek medical assistance without delay. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt action can be critical in mitigating potential harm.

Potential Symptoms While specific symptoms of overdose may not always be evident, the risk of liver damage underscores the importance of vigilance. Healthcare professionals should monitor for any signs of liver dysfunction and be prepared to initiate appropriate management protocols.

Management Procedures Upon confirmation of an overdose, healthcare providers should follow established clinical guidelines for the assessment and management of liver injury. This may include supportive care and monitoring of liver function tests, as well as considering the need for further interventions based on the severity of the overdose.

Nonclinical Toxicology

No relevant information was found regarding teratogenic or non-teratogenic effects. Additionally, there is no available data pertaining to nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening, blistering, or rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, it is recommended to stop use and consult a healthcare professional if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days, as these may indicate a serious condition.

Reports also indicate that exceeding the recommended dosage of acetaminophen can lead to liver damage. In cases of overdose, it is crucial to seek medical help or contact a Poison Control Center promptly at 1-800-222-1222, as timely medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this medication if their child has a known allergy to acetaminophen or any of the inactive ingredients present 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 fever intensifies 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.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at a temperature 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 efficacy and safety.

Additional Clinical Information

Patients should be advised that the medication is to be administered every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period. For any questions or comments, patients can contact the support line at 619-600-5632, available Monday through Friday from 9 AM to 5 PM EST.

Drug Information (PDF)

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

View product document (PDF)