Childrens Mapap

Description

No description information is available for the drug.

Uses and Indications

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

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

Dosage and Administration

This product is intended for use in children and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage is not exceeded. The appropriate dose can be determined using the following chart, which prioritizes weight for dosing; if weight is not available, age may be used as a secondary reference.

Patients should chew or crush the tablets completely before swallowing; the tablets must not be swallowed whole. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is important to not exceed 5 doses within a 24-hour period.

Dosage Chart for Chewable Tablets:

• 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 or aged 2-3 years, the recommended dose is 2 tablets.

• For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 3 tablets.

• For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 4 tablets.

• For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 5 tablets.

• For patients weighing 72-95 lb or aged 11 years, the recommended dose is 6 tablets.

Dosing may also be adjusted as directed by a healthcare professional.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. The combination may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the acetaminophen content of a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur in children who take this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within a 24-hour period or if they use it 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 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional without delay.

Healthcare providers should be consulted prior to 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.

In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center or seek emergency medical help right away, as prompt intervention is necessary for both adults and children, even in the absence of noticeable symptoms.

Discontinuation of use and consultation with a healthcare provider is recommended if any of the following occur: worsening pain that lasts more than 5 days, worsening fever that persists for more than 3 days, presence of redness or swelling, or the emergence of any new symptoms.

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 be vigilant for signs of liver injury and seek medical attention if they suspect an overdose.

Additionally, acetaminophen may 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 help.

A sore throat warning is also in place; if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Patients should stop using the product and consult a healthcare professional if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if redness or swelling is present, or if any new symptoms appear.

Before using this product, it is recommended that patients consult a doctor if they have liver disease. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

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 Childrens Mapap (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 6 years may use this medication with specific dosing recommendations based on weight. For children under 24 lb (under 2 years), a physician should be consulted prior to use. For those weighing 24-35 lb (2-3 years), the recommended dose is 2 tablets; for 36-47 lb (4-5 years), 3 tablets; for 48-59 lb (6-8 years), 4 tablets; for 60-71 lb (9-10 years), 5 tablets; and for 72-95 lb (11 years), 6 tablets.

Healthcare professionals should be aware of several warnings associated with this medication. Severe liver damage may occur if a child exceeds 5 doses in a 24-hour period, which is the maximum daily amount. Additionally, acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, or rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought. A sore throat warning is also in place; 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.

Before administering this medication, it is advised to consult a physician if the child has liver disease or is taking the blood-thinning medication warfarin. Parents or caregivers should stop use and seek medical advice if the child's pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if redness or swelling is present, or if any new symptoms appear.

For proper administration, tablets should be chewed or crushed completely before swallowing; they should not be swallowed whole. Doses may be repeated every 4 hours as needed while symptoms persist, but no more than 5 doses should be given in a 24-hour period.

Geriatric Use

There is no specific information 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. 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 acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for its use in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are adequately assessed.

Lactation

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

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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 safety and efficacy of the treatment in individuals with compromised liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. 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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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

Acetaminophen has been associated with severe skin reactions, as reported in postmarketing surveillance. Symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, cases of overdose have been reported. It is crucial to obtain medical help or contact a Poison Control Center without delay, as prompt medical attention 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. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any of the following occur: if pain worsens or persists for more than 5 days, if fever worsens or lasts more than 3 days, if redness or swelling is observed, or if any new symptoms develop.

Additionally, it is important for healthcare providers to recommend that patients consult a doctor before using this medication if their child has liver disease. Patients should also be advised to speak with a doctor or pharmacist before use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15°-30°C (59°-86°F). Care should be taken to avoid high humidity during storage to maintain product integrity. Additionally, the expiration date and lot number are located on the end flap of the packaging for reference.

Additional Clinical Information

The medication is administered orally, with specific instructions for patients to chew or crush the tablets completely before swallowing, as whole tablets should not be ingested. Dosing can be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to obtain prompt medical attention for both adults and children, even if no symptoms are immediately apparent.

Drug Information (PDF)

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

View product document (PDF)