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, providing a safe alternative for pediatric patients. The formulation contains 80 mg of acetaminophen per 1/2 teaspoon (160 mg per 5 mL) and is available in a grape flavor. Each bottle contains 4 FL.OZ. (120 mL) of the suspension, and it is comparable to the active ingredient found in Children's Tylenol® Oral Suspension. The National Drug Code (NDC) for this product is 45014-136-04.

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. For administration, the enclosed dosing syringe and adapter must be utilized; no other dosing devices should be employed.

Dosing is determined primarily by the child's weight when known. The rotating bottle label provides a guide to find the appropriate dose based on the child's weight. In cases where the weight is unknown, the age chart on the rotating label should be referenced.

The recommended dosages are as follows:

• For children under 6 months of age, consultation with a healthcare professional is advised.

• 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 healthcare professional.

If necessary, doses may be repeated every 4 hours; however, it is imperative not to exceed 5 doses within a 24-hour period.

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 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.

This product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation, as this may lead to severe allergic reactions.

Additionally, it is essential to adhere strictly to the recommended dosage; exceeding the directed amount is contraindicated to prevent potential 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, liver damage may occur if a child takes more than 5 doses within a 24-hour period 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 accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional 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. It is crucial to obtain prompt medical attention, even if no signs or symptoms are immediately apparent.

General precautions should be observed when administering this product. It should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare provider or pharmacist is advised.

Healthcare professionals should inquire about the child’s medical history before use, particularly if there is a known history of liver disease. Additionally, consultation is recommended if the child is under 6 months of age or weighs less than 12 pounds, or if the child is over 12 years of age or weighs more than 95 pounds. Caution is also warranted if the child is concurrently taking the anticoagulant warfarin; a healthcare provider or pharmacist should be consulted in such cases.

When using this product, it is essential to adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: pain worsens or persists beyond 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 defined as more than 5 doses within a 24-hour period, or who use 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 presence of acetaminophen in other medications.

In cases where patients experience a severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, they should seek medical attention promptly.

Patients with a history of liver disease should consult a doctor before using this product. Additionally, it is recommended that parents or guardians consult a healthcare professional if their child is under 6 months of age or weighs less than 12 pounds, or if the child is over 12 years of age or weighs more than 95 pounds.

While using this product, patients must adhere strictly to the recommended dosage and should discontinue use and consult a doctor if pain worsens or lasts longer than 5 days, if fever worsens or lasts longer than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients should be aware that taking more than the recommended dose may lead to liver damage. In the event of an overdose, 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 of overdose 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 also advised to seek medical guidance prior to administration.

For dosing in pediatric patients aged 6 months to under 12 years or weighing between 12 to 95 lbs., the following guidelines apply:

• 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.

It is essential for healthcare providers to consider these dosing recommendations when treating pediatric patients to ensure safety and efficacy.

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 pounds, or if they are over 12 years of age or weigh more than 95 pounds. It is essential for healthcare professionals to consider these age and weight parameters when prescribing treatment to ensure safety and efficacy in this population. Monitoring for potential adverse effects and adjusting dosages as necessary is advised to accommodate the unique physiological changes that may occur in geriatric patients.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus. Further studies are needed to determine the safety profile of this product in pregnant individuals.

Dosage adjustments may be necessary for pregnant patients; therefore, it is essential to seek recommendations from a healthcare professional regarding appropriate dosing. This product should only be used if clearly needed and after a thorough discussion with a healthcare provider about the potential risks and benefits.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider this lack of information when advising lactating mothers.

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 crucial to adhere to the recommended dosage, as exceeding this may lead to liver damage. Specifically, severe liver damage can occur if a patient takes more than five doses within a 24-hour period, which is the maximum daily allowance. Additionally, caution is advised when considering the use of acetaminophen in conjunction with other medications that also contain acetaminophen, as this combination may further increase the risk of severe liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, there is a significant risk of liver damage. Healthcare professionals should be aware that the severity of symptoms may not be immediately apparent, making it essential to act swiftly.

Immediate medical assistance is crucial. In cases of suspected overdose, it is imperative 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.

Even in the absence of noticeable signs or symptoms, prompt medical evaluation is necessary to mitigate potential complications associated with overdose. Early intervention can be vital in preventing serious health consequences.

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 several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as skin rash, swelling, and difficulty breathing. Instances of liver damage have been noted, particularly in cases of overdose or prolonged use. Gastrointestinal disturbances, including nausea and vomiting, have also been reported. Additionally, renal impairment has occurred in rare cases. Skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been documented as well.

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 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 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 advise patients to 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. It is also essential to recommend that patients speak with 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 inspected prior to use. It is essential to ensure that the foil seal over the mouth of the bottle is intact; do not use the product if the seal is torn, broken, or missing.

For optimal storage, the product should be maintained at a temperature range of 20°-25°C (68°-77°F). Proper adherence to these storage conditions is crucial to ensure 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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