Pediacare Childrens Grape

Description

Acetaminophen is presented as an oral suspension containing 160 mg of the active ingredient per 5 mL. This formulation is alcohol-free, aspirin-free, and ibuprofen-free, ensuring it is suitable for a wide range of patients. The product is free from parabens and features a grape flavor for palatability. Each bottle contains 4 FL OZ (118 mL) of the suspension, which is designed for fast-acting relief. It is indicated for use in children aged 2 to 11 years as a pain reliever and fever reducer.

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 sore throat, the common cold, influenza, headache, and toothache.

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

Dosage and Administration

This product is intended for use in pediatric patients and should be administered with caution. Prior to use, the product must be shaken well. Dosing should be determined using the provided dosage chart, which considers both weight and age. If possible, weight should be used to determine the appropriate dose; otherwise, age may be utilized.

The recommended dosing intervals are every 4 hours as needed while symptoms persist. It is imperative to measure the dose using only the dosage cup provided to ensure accuracy. The maximum allowable doses should not exceed 5 administrations within a 24-hour period. Additionally, treatment should not extend beyond 5 consecutive days unless directed by a healthcare professional.

Dosage Chart:

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

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

• For patients weighing 36 – 47 lb. and aged 4 - 5 years, the recommended dose is 7.5 mL.

• For patients weighing 48 – 59 lb. and aged 6 - 8 years, the recommended dose is 10 mL.

• For patients weighing 60 – 71 lb. and aged 9 - 10 years, the recommended dose is 12.5 mL.

• For patients weighing 72 - 95 lb. and aged 11 years, the recommended dose is 15 mL.

Contraindications

Use of this product is contraindicated in the following situations:

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

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. Healthcare professionals should advise parents to consult a doctor promptly if a child experiences a 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 exercise caution when administering this product. Healthcare providers should recommend that parents seek medical advice before use if their child has a history of liver disease. Additionally, consultation with a doctor or pharmacist is advised if the child is currently taking the anticoagulant warfarin, as interactions may occur. It is imperative that the recommended dosage is not exceeded, as this could lead to overdose.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Parents should be instructed to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days. 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 five doses within a 24-hour period or who take 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 non-prescription, and to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

In clinical practice, it is important to monitor patients for severe sore throat symptoms that persist for more than two days, especially if accompanied by fever, headache, rash, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical consultation. Patients with a history of liver disease should seek medical advice before using this product. Additionally, those taking the anticoagulant warfarin should consult a healthcare provider or pharmacist prior to use.

Patients are cautioned not to exceed the recommended dosage, as doing so may lead to overdose, which is associated with the risk of liver damage. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised, as timely intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should 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 be indicative of a serious underlying 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. Co-administration may lead to an increased risk of acetaminophen-related toxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients require careful consideration when administering this medication. The recommended dosages based on weight and age are as follows: for children under 24 pounds and under 2 years of age, consultation with a doctor is advised prior to administration. For those weighing 24 to 35 pounds (ages 2 to 3), the dose is 5 mL; for 36 to 47 pounds (ages 4 to 5), the dose is 7.5 mL; for 48 to 59 pounds (ages 6 to 8), the dose is 10 mL; for 60 to 71 pounds (ages 9 to 10), the dose is 12.5 mL; and for children weighing 72 to 95 pounds (age 11), the dose is 15 mL.

Healthcare professionals should be aware of several important warnings. Severe liver damage may occur if a child takes more than 5 doses in 24 hours, which is the maximum daily amount when combined with other acetaminophen-containing products. Parents should be advised to consult a doctor if their child has liver disease or is taking the blood-thinning medication warfarin before using this product.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt medical consultation is necessary. Additionally, the medication should not be used if the child is allergic to acetaminophen or any inactive ingredients in the product.

Parents should be instructed to stop use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or lasts more than 5 days, or if fever worsens or lasts more than 3 days, as these may indicate a serious condition. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is critical, 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 older adults may have altered pharmacokinetics and pharmacodynamics. 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 prescribing this product to women of childbearing potential and consider the lack of information when assessing the potential risks to fetal outcomes. It is advisable to weigh the benefits against any unknown risks when making treatment decisions for pregnant patients.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of this product 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 absence of guidance 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 exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the maximum daily amount of more than 5 doses in 24 hours is exceeded, or if this product is taken concurrently with other medications containing acetaminophen.

Prior to use, it is advisable for patients with liver disease to consult a healthcare professional. In cases of overdose, which may lead to liver damage, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Overdosage

Taking more than the recommended dose may lead to significant liver damage. It is imperative that in the event of an overdose, immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay.

Quick medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Prompt intervention can mitigate potential complications associated with overdose and improve patient 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 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. Instances of allergic reactions, including anaphylaxis, have also been documented following the administration of acetaminophen. Furthermore, there have been reports of renal impairment linked to the use of acetaminophen, 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 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 use if their child has liver disease. 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 various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 15° to 30° C (59° to 86° F). Care must be taken to protect the product from freezing, as well as from light exposure to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist. Clinicians should advise patients not to exceed 5 doses within a 24-hour period and to limit administration to no more than 5 days unless directed by a healthcare professional.

Patients and caregivers are strongly encouraged to consult with a doctor before giving this medication to infants or children to ensure safety and appropriateness of treatment.

Drug Information (PDF)

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

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