Childrens Accudial

Description

Children's ACCUDIAL® is an acetaminophen oral suspension formulated as a pain reliever and fever reducer. It is indicated for use in children aged 6 months to under 12 years or weighing between 12 to 95 pounds. The product is alcohol-free, aspirin-free, and ibuprofen-free, providing a safe alternative for pediatric patients. The formulation compares to the active ingredient found in Children's Tylenol® Oral Suspension. It is presented in a bubblegum flavor and is available in a 4 FL.OZ. (120 mL) bottle, delivering 80 mg of acetaminophen per 1/2 teaspoon (160 mg per 5 mL). The National Drug Code (NDC) for this product is 45014-137-04.

Uses and Indications

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

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

Dosage and Administration

Shake the product well before use. The recommended dosing is based on the child's weight when known; healthcare professionals should utilize the rotating bottle label to determine the appropriate dose. This method provides the most accurate dosing. In cases where the child's weight is unknown, the age chart on the rotating label should be used to ascertain the correct dosage.

For children aged under 6 months, consultation with a physician is advised prior to administration. For children aged 6 months to under 2 years, the recommended dose is 2.5 mL (½ teaspoon). For those aged 2 to under 4 years, the dose increases to 5 mL (1 teaspoon). Children aged 4 to under 6 years should receive 7.5 mL (1½ teaspoons), while those aged 6 to under 9 years should be given 10 mL (2 teaspoons). For children aged 9 to under 11 years, the appropriate dose is 12.5 mL (2½ teaspoons), and for those aged 11 to under 12 years, the dose is 15 mL (3 teaspoons).

Dosing may be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period. It is imperative to use only the enclosed dosing syringe and adapter for administration; the use of any other dosing device is not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, 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.

• In patients with a known allergy to acetaminophen or any of the inactive ingredients present in this formulation.

• Exceeding the recommended dosage is contraindicated, as it may lead to adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that administering more than 5 doses within a 24-hour period, or combining this product with other medications containing acetaminophen, significantly increases the risk of liver injury.

In cases where a child presents with a severe sore throat that persists beyond 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly. Such symptoms may indicate a more serious underlying condition that requires immediate medical evaluation.

Healthcare providers must emphasize the importance of adhering to the recommended dosage. An overdose can lead to liver damage, and in such instances, immediate medical assistance should be sought. Caregivers should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent.

General precautions should be taken when administering this product. It is contraindicated to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the acetaminophen content of a medication, consultation with a healthcare professional is advised. Additionally, a physician should be consulted prior to use if the child has a history of liver disease, is under 6 months of age or weighs less than 12 lbs, or is over 12 years of age or weighs more than 95 lbs. Furthermore, caregivers should seek advice from a doctor or pharmacist if the child is concurrently taking warfarin, a blood-thinning medication.

While using this product, it is crucial to adhere strictly to the directed dosage. Caregivers should be instructed to discontinue use and consult a physician if the child experiences worsening pain lasting more than 5 days, fever that persists beyond 3 days, the emergence of new symptoms, or any signs of redness or swelling, as these may indicate a serious medical condition requiring further investigation.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly concerning liver health and other serious conditions.

Severe liver damage may occur if the maximum daily dosage 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 healthcare professional before use.

In addition, patients should be cautious if they experience a severe sore throat that persists for more than two days, especially if accompanied by fever, headache, rash, nausea, or vomiting. In such cases, it is advised to seek medical attention promptly.

Patients should not use this product if they are allergic to acetaminophen or any of the inactive ingredients. It is also recommended to consult a doctor before use if the patient is under six months of age or weighs less than 12 pounds, or if they are over 12 years of age and weigh more than 95 pounds. Furthermore, patients taking the blood-thinning medication warfarin should seek medical advice prior to using this product.

While using this product, it is crucial to adhere strictly to the recommended dosage. Patients should discontinue use and consult a healthcare provider if pain worsens or persists beyond five days, if fever worsens or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. Prompt medical attention is essential, even if no signs or symptoms are initially apparent.

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

Pediatric Use

Pediatric patients under 6 months of age or weighing less than 12 lbs should consult a healthcare professional before use. Similarly, children over 12 years of age or weighing more than 95 lbs are advised to seek medical guidance prior to administration.

For pediatric patients aged 6 months to under 12 years, the recommended dosages are as follows:

• 6 months to under 2 years: 2.5 mL (½ tsp)

• 2 to under 4 years: 5 mL (1 tsp)

• 4 to under 6 years: 7.5 mL (1½ tsp)

• 6 to under 9 years: 10 mL (2 tsp)

• 9 to under 11 years: 12.5 mL (2½ tsp)

• 11 to under 12 years: 15 mL (3 tsp) or as directed by a healthcare professional

This product is specifically indicated for use in children aged 6 months to under 12 years or those weighing between 12 and 95 lbs.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they are under 6 months of age or weigh less than 12 lbs, or if they are over 12 years of age and weigh more than 95 lbs. It is essential for healthcare providers to assess the appropriateness of treatment in this population, considering potential differences in pharmacokinetics and pharmacodynamics that may affect safety and efficacy. Monitoring for adverse effects and therapeutic response is recommended to ensure optimal care in geriatric patients.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. The available data does not indicate any contraindications or risks associated with the use of acetaminophen during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided in the prescribing information. The insert does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the overall clinical context when advising pregnant patients.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns noted in the available data.

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 use, particularly if they have a history of liver disease. It is critical to adhere to the recommended dosing guidelines, as exceeding five doses within a 24-hour period may lead to severe liver damage. Additionally, patients must be cautious when taking acetaminophen in conjunction with other medications that contain acetaminophen, as this combination can also result in significant liver injury.

In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought. Contacting a Poison Control Center is advised, as prompt intervention is essential, even in the absence of noticeable signs or symptoms of liver damage. Monitoring liver function may be warranted in patients with compromised liver health to prevent potential adverse effects.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals recognize the seriousness of this situation and act swiftly.

Immediate medical assistance should be sought in cases of suspected overdose. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt intervention is crucial, as symptoms may not be immediately apparent. Even in the absence of noticeable signs or symptoms, the risk of serious complications necessitates urgent medical evaluation and management.

Healthcare professionals should ensure that patients and caregivers are aware of these critical steps to mitigate the risks associated with overdose.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

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 who exceed the recommended dosage. Allergic reactions, including anaphylaxis, have also been reported following the use of acetaminophen. Furthermore, there have been instances of renal impairment associated with acetaminophen use, especially in patients with pre-existing kidney conditions.

Patient Counseling

Healthcare providers should advise patients not to use this product in conjunction with any other medication that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist for clarification.

It is important to inform patients that this product should not be administered if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the formulation.

Patients should be instructed to discontinue use and seek medical advice 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 new symptoms develop, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires medical attention.

While using this product, patients must be reminded to adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should also recommend that patients consult a doctor prior to use if their child has liver disease. Additionally, it is advisable to seek medical guidance before administering this product to children who are either under 6 months of age or weigh less than 12 pounds, as well as to those over 12 years of age or weighing more than 95 pounds.

Lastly, patients should be encouraged to discuss any concurrent use of the blood-thinning medication warfarin with their healthcare provider or pharmacist before using this product.

Storage and Handling

The product is supplied in a container that must be stored at a temperature range of 20°-25°C (68°-77°F). It is essential to ensure that the foil seal over the mouth of the bottle remains intact; the product should not be used if the seal is torn, broken, or missing. Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with instructions to shake well before use. Dosing may be repeated every four hours as needed, but should not exceed five doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor prior to use if the child has liver disease, is under 6 months of age or weighs less than 12 lbs, or is over 12 years of age or weighs more than 95 lbs. Additionally, it is advised to seek guidance from a doctor or pharmacist if the child is concurrently taking the blood-thinning medication warfarin.

Drug Information (PDF)

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

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