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. This product is alcohol-free, aspirin-free, and ibuprofen-free, and it contains no dyes. The suspension is presented in a cherry flavor and is available in a 4 FL.OZ. (120 mL) bottle. Each 1/2 teaspoon (2.5 mL) delivers 80 mg of acetaminophen, equating to 160 mg per 5 mL. The National Drug Code (NDC) for this product is 45014-139-04.

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

The product must be shaken well before use. Dosing is determined primarily by the child's weight; healthcare professionals should refer to the rotating bottle label to identify the appropriate dose based on the child's weight for the most accurate administration. In cases where the child's weight is unknown, the age chart on the rotating label should be utilized.

The recommended dosages are as follows:

• For children under 6 months of age, 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 children aged 2 to under 4 years, the recommended dose is 5 mL (1 teaspoon).

• For children aged 4 to under 6 years, the recommended dose is 7.5 mL (1½ teaspoons).

• For children aged 6 to under 9 years, the recommended dose is 10 mL (2 teaspoons).

• For children aged 9 to under 11 years, the recommended dose is 12.5 mL (2½ teaspoons).

• For children aged 11 to under 12 years, the recommended dose is 15 mL (3 teaspoons).

• Dosing may also be adjusted as directed by a physician.

Doses 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 in this formulation, as this may lead to severe allergic reactions.

• Exceeding the recommended dosage is contraindicated, as it may result in serious adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if not used according to the guidelines. Healthcare professionals should be aware that liver damage may occur if a child takes more than 5 doses within a 24-hour period, which is the maximum daily amount, or if it is used concurrently with other medications containing acetaminophen.

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.

Overdose of this product can lead to significant liver damage. 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. Prompt medical attention is critical, even if the patient does not exhibit any signs or symptoms of overdose.

General precautions should be taken prior to administration. Healthcare providers should advise parents to consult a physician if their child has liver disease. Additionally, it is recommended to seek medical advice before use in children under 6 months of age or weighing less than 12 lbs, as well as in those over 12 years of age or weighing more than 95 lbs. Furthermore, consultation with a doctor or pharmacist is advised if the child is concurrently taking the anticoagulant warfarin.

Patients should be instructed to discontinue use and contact a healthcare professional if any of the following occur: pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, or who take this product in conjunction with other medications containing acetaminophen. Patients should be advised to avoid using this product with any other drug containing acetaminophen, whether prescription or nonprescription, and to consult a healthcare professional if uncertain about the presence of acetaminophen in other medications.

In cases where patients experience a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to seek medical attention promptly. Additionally, patients with a history of liver disease should consult a healthcare provider before using this product.

This product is not recommended for use in children under 6 months of age or weighing less than 12 lbs, as well as in those over 12 years of age or weighing more than 95 lbs, without prior consultation with a healthcare professional. Patients taking the anticoagulant warfarin should also seek advice from a doctor or pharmacist before use.

Patients are advised to adhere strictly to the recommended dosage and to discontinue use and consult a healthcare provider if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, 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 should be made at 1-800-222-1222. Prompt medical attention is critical, even if no signs or symptoms are immediately 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 due to the potential for altered anticoagulant effects. Adjustments to the dosage of warfarin may be required based on clinical judgment and laboratory results.

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 doctor before use. Similarly, those 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 doctor

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 may not have specific information regarding the use of Children's Accudial Pain Reliever/Fever Reducer (acetaminophen suspension) as the prescribing information primarily addresses pediatric use. Consequently, there are no recommended age considerations, dosage adjustments, or safety concerns explicitly outlined for geriatric patients.

Healthcare providers should exercise caution when considering the administration of this medication to elderly patients, given the absence of data on its safety and efficacy in this population. It is advisable to monitor these patients closely for any adverse effects or unusual responses to treatment, as the pharmacokinetics and pharmacodynamics of acetaminophen may differ in older adults.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. Currently, there is no information available about safety concerns related to pregnancy, nor are there any dosage modifications recommended for pregnant individuals. Additionally, no special precautions regarding the use of this product during pregnancy have been provided. Healthcare professionals should consider the lack of data when advising pregnant patients or women of childbearing potential.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised.

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.

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 five doses within a 24-hour period, as this represents the maximum daily dosage. Additionally, caution is advised when considering concurrent use 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 assistance should be sought, or the patient should contact a Poison Control Center without delay. It is crucial to obtain prompt medical attention, even in the absence of noticeable signs or symptoms of liver damage, to mitigate potential complications.

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 without delay, utilizing the national hotline at 1-800-222-1222. This resource can provide critical guidance on the appropriate steps to take in managing the overdose.

Prompt medical attention is essential, even in the absence of noticeable signs or symptoms. Early intervention can be crucial in mitigating the risk of severe complications associated with overdose. Therefore, vigilance and proactive measures are necessary to ensure patient safety and effective management of the situation.

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 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 to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that this product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if any of the following occur: pain worsens or persists for more than 5 days, fever worsens or lasts more than 3 days, new symptoms develop, or if there is any redness or swelling, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. Additionally, healthcare providers should recommend that patients consult a doctor before use if their 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. Furthermore, patients should be advised to seek guidance from a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin.

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, and it is important to shake well before use. Dosing may be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor before 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 taking warfarin, a blood-thinning medication. Patients should avoid using this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription, and should confirm with a healthcare professional if uncertain about the presence of acetaminophen in other drugs.

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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