Pediacare Childrens Acetaminophen Grape

Description

Acetaminophen is an oral suspension formulated to provide effective pain relief. Each 5 mL dose contains 160 mg of acetaminophen. This formulation is alcohol-free, aspirin-free, and ibuprofen-free, ensuring it is suitable for a wide range of patients. Additionally, it does not contain parabens. The product is presented in a grape flavor, enhancing palatability. The total volume of the suspension is 1 fluid ounce (30 mL).

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, headache, flu, sore throat, and toothache.

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

Dosage and Administration

Healthcare professionals should ensure that the product is shaken well before use. The appropriate dosage should be determined using the dosage chart provided, prioritizing weight for dosing when possible; if weight is not available, age may be used as a secondary measure.

The enclosed measuring syringe must be utilized for accurate dosing. The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses administered within a 24-hour period.

Dosage Chart:

• For patients weighing under 24 lb and under 2 years of age, it is advised to consult a doctor for the appropriate dose.

• For patients weighing between 24-35 lb and aged 2-3 years, the recommended dose is 5 mL.

It is imperative to adhere to these guidelines to ensure safe and effective administration 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 children with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation.

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.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning 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 essential to consult a healthcare professional promptly.

General Precautions Prior to use, it is advisable to consult a physician if the child has a history of liver disease. Additionally, consultation with a doctor or pharmacist is recommended if the child is currently taking the anticoagulant warfarin.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center at 1-800-222-1222 without delay. Quick intervention is vital for both adults and children, even in the absence of noticeable signs or symptoms.

When to Stop Use and Consult a Doctor Discontinue use and seek medical advice if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days. These may be indicative of a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of five doses within a 24-hour period or who take the product concurrently with other medications containing acetaminophen. Patients should be aware that acetaminophen can lead to severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. The product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Patients should verify the presence of acetaminophen in other medications with a doctor or pharmacist if uncertain. Additionally, the product is contraindicated in patients with known allergies to acetaminophen or any inactive ingredients contained within the formulation.

Before using this product, patients with liver disease should consult a healthcare provider. Furthermore, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist prior to use. It is crucial for patients to adhere to the recommended dosage and to avoid exceeding it, as overdose may result in liver damage. In cases of overdose, immediate medical attention is essential, and patients should contact a Poison Control Center without delay.

Patients are advised to discontinue use and consult a healthcare professional if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days, as these may indicate a serious condition.

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 increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose and associated hepatotoxicity is heightened when multiple sources of acetaminophen are used simultaneously. Patients are advised to verify the presence of acetaminophen in any other medications they may be taking by consulting a healthcare provider or pharmacist.

Packaging & NDC

Below are the non-prescription pack sizes of Pediacare Childrens Acetaminophen Grape (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age who weigh less than 24 lb should be advised to consult a healthcare professional before administration. For children aged 2 to 3 years weighing between 24 to 35 lb, the recommended dose is 5 mL.

It is important to note that this product contains acetaminophen, and severe liver damage may occur if a child exceeds 5 doses within a 24-hour period, which is the maximum daily amount. Additionally, an overdose, defined as taking more than the recommended dose, may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is crucial for both children and adults, even if no signs or symptoms are present.

Geriatric Use

There is no specific information regarding the use of Pediacare Children's Acetaminophen Grape in geriatric patients. Therefore, healthcare providers should exercise caution when considering this medication for elderly patients. It is advisable to monitor for potential adverse effects and to evaluate the appropriateness of dosage, as pharmacokinetics may differ in this population. Given the lack of targeted studies or data, clinicians should rely on clinical judgment and consider individual patient factors when prescribing this medication to geriatric patients.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when considering this product for women of childbearing potential and weigh the potential risks against the benefits. It is advisable to discuss any potential implications with patients who are pregnant or planning to become pregnant.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of this product on a nursing infant are not known.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be prudent in these patients to ensure safety and efficacy.

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 the maximum recommended dosage of 5 doses within a 24-hour period or if they concurrently use other medications containing acetaminophen.

It is critical to adhere to the recommended dosing guidelines, as exceeding these may lead to overdose and subsequent liver damage. In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dosage is exceeded. It is imperative that healthcare professionals remain vigilant regarding the signs and symptoms of overdose, as these may not always be immediately apparent.

Immediate medical assistance is crucial. In cases of suspected overdose, it is recommended 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. This step is essential for both adults and children, as prompt intervention can mitigate the risk of serious complications, even in the absence of noticeable symptoms.

Healthcare providers should ensure that patients and caregivers are aware of the importance of quick medical attention in overdose situations, reinforcing that early intervention can be critical in preventing severe 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

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

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 intensifies 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 using this medication if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 15° to 30° C (59° to 86° F). Care should be taken to protect the product from freezing, as well as from exposure to light, to ensure its integrity and efficacy. Proper handling and storage conditions are critical for maintaining the quality of the product.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)