Childrens Acetaminophen

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the available data.

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, immunizations, 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 healthcare professionals should refer to the dosage chart below to determine the appropriate dose based on the patient's weight or age. Prior to administration, the product must be shaken well.

For dosing, if possible, weight should be used; otherwise, age may be utilized. Doses may be repeated every 4 hours as needed, but it is imperative not to exceed 5 doses within a 24-hour period. Continuous use beyond 5 days should only occur under the guidance of a physician. The enclosed measuring cup must be used for accurate dosing.

Dosage Chart:

• For patients weighing under 24 lbs. (under 2 years): Consult a doctor for the appropriate dose.

• For patients weighing 24-35 lbs. (2-3 years): Administer 1 teaspoon (5 mL).

• For patients weighing 36-47 lbs. (4-5 years): Administer 1½ teaspoons (7.5 mL).

• For patients weighing 48-59 lbs. (6-8 years): Administer 2 teaspoons (10 mL).

• For patients weighing 60-71 lbs. (9-10 years): Administer 2½ teaspoons (12.5 mL).

• For patients weighing 72-95 lbs. (11 years): Administer 3 teaspoons (15 mL).

Adherence to these guidelines is essential for safe and effective use of the product.

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. If there is uncertainty regarding the presence of acetaminophen in another medication, 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.

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 24 hours or if they are concurrently using other medications that 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 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 inquire about any pre-existing liver disease in children prior to recommending this product. Additionally, it is essential to consult with a doctor or pharmacist if the child is currently taking warfarin, a blood-thinning medication, to avoid potential interactions.

While using this product, it is critical to adhere strictly to the recommended dosage guidelines. Exceeding the recommended dose can lead to serious health risks, including overdose.

In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. Quick medical attention is vital for both adults and children, even if no immediate signs or symptoms are apparent.

Parents should be advised to discontinue use and consult a healthcare professional 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 signs may indicate a serious condition that necessitates further medical 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 is exceeded, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen. Patients with a history of liver disease should consult a doctor prior to use. Additionally, caution is advised for patients taking blood-thinning medications such as warfarin, and they should seek guidance from a healthcare professional before using this product.

In the event of a sore throat, patients are advised to consult a doctor if the sore throat is severe, persists for more than two days, or is accompanied by symptoms such as fever, headache, rash, nausea, or vomiting. These symptoms may indicate a serious condition that requires medical attention.

Patients should discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, if pain worsens or lasts longer than five days, or if fever intensifies or persists beyond three days.

An overdose warning is also critical; taking more than the recommended dose may lead to liver damage. In cases of suspected overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Quick medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

It is important to avoid using this product in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription. Patients should verify the contents of any other medications with a healthcare provider or pharmacist if there is uncertainty regarding acetaminophen inclusion. Furthermore, this product should not be used by individuals who are allergic to acetaminophen or any of its inactive ingredients.

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

Pediatric Use

Pediatric patients should be dosed according to weight or age, as outlined in the dosing chart provided. For children under 2 years of age and weighing less than 24 lbs, a physician should be consulted before administration. For those aged 2 to 3 years and weighing between 24 to 35 lbs, the recommended dose is 1 teaspoon (5 mL). Children aged 4 to 5 years and weighing 36 to 47 lbs should receive 1½ teaspoons (7.5 mL). For children aged 6 to 8 years and weighing 48 to 59 lbs, the dose is 2 teaspoons (10 mL). For those aged 9 to 10 years and weighing 60 to 71 lbs, the appropriate dose is 2½ teaspoons (12.5 mL). Finally, children aged 11 years and weighing between 72 to 95 lbs should be given 3 teaspoons (15 mL).

Dosing may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period. Continuous use beyond 5 days should only occur under the guidance of a healthcare professional. It is essential to use the enclosed measuring cup for accurate dosing. This product does not contain directions or complete warnings for adult use.

Geriatric Use

There is no specific information regarding the use of Children's Acetaminophen in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful clinical judgment. Monitoring for efficacy and safety is advised in this population.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus are not clearly defined, and caution is advised when considering the use of this medication. Dosage adjustments may be necessary, and it is important for healthcare professionals to provide guidance on appropriate dosing. Use during pregnancy should be under the supervision of a healthcare professional to ensure the safety of both the patient and the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk, risks to breastfed infants, or any other lactation-related considerations.

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 absence of guidance necessitates careful clinical judgment and monitoring.

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 maximum daily dosage of 5 doses within a 24-hour period is exceeded, or if it is used concurrently with other medications containing acetaminophen, whether prescription or non-prescription.

It is imperative that patients with compromised liver function avoid the use of any additional acetaminophen-containing products. Overdosing on acetaminophen can lead to significant liver damage; therefore, in the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Overdosage

Taking more than the recommended dose may lead to significant liver damage. It is imperative that in the event of an overdose, immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay.

Quick medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Prompt intervention can mitigate potential complications associated with overdose and improve outcomes.

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 compound in these areas.

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 product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. They should be instructed 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, if a fever worsens or lasts more than three days, patients should be advised to stop use and consult a doctor, as these may indicate a serious underlying condition.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and to be aware of the overdose warning associated with this product. It is also crucial to recommend that patients consult a doctor before use if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist 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 a configuration that includes an NDC number for identification. It should be stored at room temperature, specifically within the range of 15º to 30ºC (59º to 86ºF). It is essential to protect the product from freezing and to shield it from light exposure to maintain its integrity.

Additionally, the product features a tamper-evident design. Users are advised not to use the product if the printed inner cap seal is broken or missing, ensuring safety and quality.

Additional Clinical Information

The medication is administered orally, with the option to repeat the dose every 4 hours as needed. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period and should not continue administration for more than 5 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 Childrens Acetaminophen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)