Childrens Acetaminophen

Description

Children's Acetaminophen oral suspension is formulated to provide effective relief as a fever reducer and pain reliever for pediatric patients aged 2 to 11 years. Each 1/2 teaspoon (approximately 2.5 mL) contains 80 mg of acetaminophen, equating to 160 mg per 5 mL. The product is presented in a grape flavor and is packaged in a 4 FL OZ (118 mL) bottle. The National Drug Code (NDC) for this formulation is 59999-001-04.

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 the common cold, influenza, headache, sore throat, and toothache.

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

Dosage and Administration

Healthcare professionals should ensure that the product is administered according to the following guidelines. Prior to use, the product must be shaken well. It is imperative to utilize only the enclosed dosing cup for accurate measurement.

Dosing should be determined based on the patient's weight or age, as outlined in the dosage chart below. The maximum dosage should not exceed five doses within a 24-hour period, and treatment should not extend beyond five days unless directed by a physician. If necessary, doses may be repeated every four hours.

Dosage Chart:

• For patients weighing under 24 lb or under 2 years of age, consult a physician before administration.

• For patients weighing 24-35 lb (ages 2-3 years), administer 1 teaspoon (5 mL).

• For patients weighing 36-47 lb (ages 4-5 years), administer 1 1/2 teaspoons (7.5 mL).

• For patients weighing 48-59 lb (ages 6-8 years), administer 2 teaspoons (10 mL).

• For patients weighing 60-71 lb (ages 9-10 years), administer 2 1/2 teaspoons (12.5 mL).

• For patients weighing 72-95 lb (age 11 years), administer 3 teaspoons (15 mL).

It is crucial to adhere to the specified dosing limits to avoid potential liver complications and overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited. Healthcare professionals should be consulted prior to using this product in conjunction with other medications to avoid potential overdose.

• This product should not be administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation.

• Exceeding the recommended dosage while using this product is contraindicated due to the risk of overdose.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within a 24-hour period or if they are concurrently using other medications that also contain acetaminophen. Healthcare professionals should advise parents to monitor their child's dosage closely to prevent potential overdose.

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, it is imperative to consult a physician promptly. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Healthcare providers should exercise caution and recommend that parents consult a doctor before administering this product if their 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 warfarin, a blood-thinning medication, due to potential interactions.

While using this product, it is crucial to adhere strictly to the recommended dosage to avoid overdose. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Quick medical attention is essential, even if no signs or symptoms are initially apparent.

Parents should be instructed to discontinue use and consult a healthcare professional if any of the following occur: pain worsens or lasts longer than 5 days, fever worsens or persists for more than 3 days, new symptoms develop, or if there is any redness or swelling. These may be indicative of a serious condition that necessitates further medical investigation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of five doses within a 24-hour period or who take this product in conjunction with other medications containing acetaminophen. Patients should be advised to avoid using this product alongside any other drug containing acetaminophen, whether prescription or nonprescription, and to consult a healthcare professional if there is uncertainty regarding the use of other medications.

In clinical observations, it is important to note that if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should seek medical attention promptly. Additionally, patients with a history of liver disease should consult a doctor before using this product. Caution is also advised for patients taking the blood-thinning medication warfarin, and they should discuss potential interactions with a healthcare provider.

Patients must adhere to the recommended dosing guidelines, as exceeding the recommended dose may lead to overdose and subsequent liver damage. In the event of an overdose, immediate medical assistance should be sought, and patients are encouraged to contact a Poison Control Center without delay, even if no signs or symptoms are present.

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

Drug Interactions

It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication in conjunction with other drugs, particularly if there is uncertainty regarding potential interactions.

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated. This is to prevent the risk of acetaminophen overdose, which can lead to serious liver damage.

Additionally, caution is warranted when this medication is used in pediatric patients who are concurrently taking warfarin, a blood-thinning agent. It is recommended that a healthcare provider be consulted before initiating treatment in such cases to ensure appropriate monitoring and dosage adjustments, if necessary.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not be given this medication without consulting a doctor. For children aged 2 to 3 years (24-35 lbs), the recommended dosage is 1 teaspoon (5 mL). For those aged 4 to 5 years (36-47 lbs), the recommended dosage increases to 1 1/2 teaspoons (7.5 mL). Children aged 6 to 8 years (48-59 lbs) should receive 2 teaspoons (10 mL), while those aged 9 to 10 years (60-71 lbs) should be given 2 1/2 teaspoons (12.5 mL). For children aged 11 years (72-95 lbs), the recommended dosage is 3 teaspoons (15 mL).

It is important not to exceed 5 doses within a 24-hour period and to limit use to no more than 5 days unless directed by a doctor. Prior to administration, consultation with a healthcare professional is advised if the child has liver disease or is taking the blood-thinning medication warfarin.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to consider individual patient factors, including the presence of comorbidities and the potential for altered pharmacokinetics in this population.

Due to the lack of clinical data specifically addressing geriatric use, careful monitoring for efficacy and safety is recommended. Dose adjustments may be necessary based on the clinical response and tolerance observed in elderly patients.

Pregnancy

There is no specific information available regarding the use of Children's Acetaminophen during pregnancy. The prescribing information does not indicate any contraindications or risks associated with the use of acetaminophen in pregnant patients. Additionally, no dosage modifications for pregnant individuals are specified. The insert does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the benefits against any potential risks.

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 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 consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The formulation contains acetaminophen, which poses a risk of severe liver damage if the patient exceeds the maximum recommended dosage of five doses within a 24-hour period. Additionally, caution is advised when this product is taken concurrently with other medications that also contain acetaminophen, as this may further increase the risk of liver injury.

In the event of an overdose, which may occur if the recommended dosage is exceeded, immediate medical attention is essential. Patients should seek help or contact a Poison Control Center without delay, even if no signs or symptoms of overdose are apparent. Prompt intervention is critical to mitigate potential liver damage.

Overdosage

In cases of overdose, the administration of doses exceeding the recommended amount may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential consequences of such an event.

Immediate medical assistance is crucial in the event of an overdose. Healthcare providers should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

It is important to note that prompt medical attention is essential, even in the absence of noticeable signs or symptoms of overdose. Early intervention can significantly mitigate the risk of severe complications associated with liver damage.

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 rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been noted in patients taking acetaminophen, particularly among those with underlying liver disease or those exceeding the recommended dosage. Instances of allergic reactions, including anaphylaxis, have also been documented following the administration of acetaminophen. Furthermore, there have been reports of renal impairment linked to the use of acetaminophen, especially in patients with pre-existing kidney conditions.

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 containing acetaminophen, whether prescription or nonprescription. Patients should be encouraged to consult a doctor or pharmacist if they are uncertain about the use of other medications alongside this product.

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 formulation. They should be instructed to discontinue use and seek medical advice if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and inform patients about the risks associated with exceeding this dose, including the potential for overdose. Additionally, patients should be advised to consult a doctor before using this product if their child has liver disease. It is also recommended that patients speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits.

Additional Clinical Information

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

Drug Information (PDF)

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

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