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 an active ingredient that compares to that of Children's Tylenol® Oral Suspension. The suspension is flavored with strawberry and is available in a 4 fluid ounce (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 45014-138-04.

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 referenced.

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 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 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.

• The product should not be used in excess of the recommended dosage, as this may increase the risk of 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 liver damage may occur if a child takes more than 5 doses within a 24-hour period or if acetaminophen is administered concurrently with other medications containing acetaminophen.

In cases where a child presents with 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 consult a physician promptly.

Healthcare providers must emphasize the importance of adhering to the recommended dosage, as taking more than the prescribed amount can lead to overdose and potential 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 crucial, even if the patient does not exhibit any signs or symptoms of overdose.

General precautions should be taken into account prior to administration. It is advisable to consult a physician if the child has a history of liver disease. Additionally, caregivers should seek medical advice before use if the child is under 6 months of age or weighs less than 12 lbs, or if the child is over 12 years of age or weighs more than 95 lbs. Furthermore, it is recommended to consult a doctor or pharmacist if the child is currently taking the anticoagulant warfarin.

Healthcare professionals should instruct caregivers 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 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 taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use it concurrently with other medications containing acetaminophen. Patients should be advised to consult a doctor promptly if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should seek clarification from a healthcare professional if they are uncertain whether a drug contains acetaminophen. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

Before using this product, patients should consult a doctor if they have liver disease, are under six months of age or weigh less than 12 pounds, or are over 12 years of age or weigh more than 95 pounds. It is also advisable for patients to discuss the use of this product with a healthcare provider if they are taking the blood-thinning medication warfarin.

While using this product, patients must adhere strictly to the recommended dosage. They should discontinue use and consult a doctor if pain worsens or persists for more than 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.

Patients should be aware that taking more than the recommended dose may lead to overdose and potential 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 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 interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to anticoagulation. 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. For children aged 6 months to under 12 years or weighing between 12 to 95 lbs, the following dosing guidelines apply:

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

• For children 2 to under 4 years: 5 mL (1 tsp).

• For children 4 to under 6 years: 7.5 mL (1½ tsp).

• For children 6 to under 9 years: 10 mL (2 tsp).

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

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

This product is specifically indicated for pediatric patients aged 6 months to under 12 years or those weighing between 12 to 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 or weigh more than 95 lbs. 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 and appropriate dosage adjustments may be necessary based on individual patient characteristics and clinical findings.

Pregnancy

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

Lactation

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

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 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 acetaminophen is taken concurrently with other medications containing acetaminophen, as this combination may also result in severe liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

Taking more than the recommended dose may lead to significant liver damage. It is essential for healthcare professionals to recognize the seriousness of an overdose situation and to act swiftly.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt medical attention is critical, even if the patient does not exhibit any noticeable signs or symptoms of overdose. Early intervention can be vital in preventing 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 question.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as skin rash, hives, and swelling of the face, lips, or tongue. Instances of liver damage have been particularly noted in cases of overdose or prolonged use, with hepatotoxicity also observed in patients with underlying liver disease or those consuming alcohol. Gastrointestinal disturbances, including nausea and vomiting, have been reported, along with renal impairment in patients with pre-existing kidney conditions.

Additionally, rare cases of serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been documented. Reports of anaphylaxis have also been received. There is an increased risk of bleeding in patients taking warfarin or other anticoagulants. Other unspecified adverse reactions have been reported 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 not to use this product in conjunction with any other medications that contain 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 made aware of the potential for allergic reactions. They should be instructed to avoid 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 counsel patients 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, as these may indicate a serious condition.

When using this product, patients should be reminded not to exceed the recommended dosage. Additionally, it is crucial to advise patients to consult a doctor before use if their child has liver disease or 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.

Lastly, patients should be encouraged to speak with a doctor or pharmacist before using this product 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 container with a foil seal over the mouth of the bottle. It is essential to ensure that the foil seal 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, with instructions 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 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 advisable to seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant 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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