Pediacare Single Dose Fever Reducer

Description

Acetaminophen is presented as an oral suspension with a concentration of 160 mg per 5 mL. Each package contains six single-dose packets, with each packet containing 0.34 fluid ounces (10 mL) of the suspension.

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, influenza, headache, sore throat, and toothache.

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

Dosage and Administration

Each packet of the medication provides a single dose intended for children weighing between 48 to 59 pounds or aged 6 to 8 years. When determining the appropriate dose, it is recommended to use the child's weight; if weight is not available, age may be used as a guide.

To administer the medication, healthcare professionals should instruct caregivers to follow these steps:

1. Fold back the packet at the dotted line to expose the tear strip.

2. Tear across the packet at the exposed tear slit (do not tear up and down).

3. Remove and discard the strip.

4. Squeeze the medicine directly into the child’s mouth.

If necessary, the dose may be repeated every 4 hours while symptoms persist. However, it is important to ensure that the total number of doses does not exceed 5 times within a 24-hour period. Additionally, the medication should not be administered for more than 5 consecutive days unless directed by a physician.

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 a medication, consultation with a healthcare professional is advised.

This product should not be administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Additionally, it is essential to adhere to the recommended dosage, as exceeding this may lead to overdose, which poses significant health risks.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they concurrently use other medications containing acetaminophen. Healthcare professionals should advise parents and caregivers to monitor the total intake of acetaminophen from all sources to prevent potential toxicity.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Before administering this product, healthcare providers should inquire about any existing liver disease in the child. Additionally, it is essential to consult with a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant, as interactions may occur.

While using this product, it is critical to adhere strictly to the recommended dosage guidelines to avoid overdose. In the event of an accidental overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222. Rapid intervention is crucial, even if no symptoms are immediately apparent.

Parents and caregivers should be instructed to discontinue use and seek medical advice if the child's pain worsens or persists beyond 5 days, if fever intensifies or lasts longer than 3 days, if new symptoms develop, or if there is any redness or swelling. These signs may indicate a serious condition that necessitates further medical assessment.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if the product is taken concurrently with other medications containing acetaminophen. Patients should be advised not to use this product in conjunction with 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 addition, patients should seek medical advice before using this product if they have liver disease or are taking the blood-thinning medication warfarin.

While using this product, it is crucial to adhere to the recommended dosage to avoid overdose. Signs of overdose may include severe liver damage, and in such cases, immediate medical attention is necessary. Patients should contact a healthcare provider or a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are present.

Patients are advised to discontinue use and consult a doctor if pain worsens or persists for more than 5 days, if fever worsens or lasts for more than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Furthermore, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should seek prompt medical attention.

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 Single Dose Fever Reducer (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Each packet of this medication provides a single dose for pediatric patients based on weight and age. For children weighing 48 to 59 pounds or aged 6 to 8 years, one packet is recommended. For those weighing 36 to 47 pounds or aged 4 to 5 years, one packet is also appropriate. When possible, weight should be used to determine the dose; otherwise, age may be utilized.

Pediatric patients should not exceed 5 doses within a 24-hour period, and the medication should not be administered for more than 5 consecutive days unless directed by a healthcare professional.

Caution is advised due to the presence of acetaminophen, as severe liver damage may occur if the maximum daily amount of 5 doses is exceeded, particularly when combined with other acetaminophen-containing products. Parents and caregivers should consult a doctor before use if the child has liver disease. Additionally, it is recommended to seek advice from a healthcare provider or pharmacist if the child is concurrently taking the anticoagulant warfarin.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. While potential risks to the fetus are not clearly defined, caution is advised when considering the use of acetaminophen during pregnancy. There are no specific dosage modifications for pregnant individuals; therefore, it is essential for healthcare providers to offer guidance tailored to the individual patient's circumstances.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 use, particularly if they have a history of liver disease. It is essential to assess liver function before initiating treatment, as compromised liver function may influence the safety and efficacy of the medication.

In the event of an overdose, patients are at an increased risk of liver damage. Therefore, it is crucial to adhere strictly to the recommended dosage. If an accidental overdose occurs, immediate medical attention is necessary, and patients should contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are present. Prompt intervention is vital to mitigate potential liver injury.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should be aware that even in the absence of immediate symptoms, prompt medical intervention is essential.

In cases of accidental overdose, it is imperative to seek medical assistance without delay. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on appropriate management strategies. Quick medical attention can be critical in mitigating potential harm, and patients should not wait for symptoms to manifest before seeking help.

Monitoring and supportive care may be necessary, depending on the severity of the overdose and the clinical presentation of the patient.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 in some patients following the administration of acetaminophen. Furthermore, there have been instances of renal impairment linked to the use of acetaminophen, especially in individuals 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 taking more than the recommended dose may lead to liver damage. In the event of an accidental overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is crucial even if no signs or symptoms are present.

Patients should be cautioned against using this medication in conjunction with any other drug that contains acetaminophen, whether prescription or non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Healthcare providers should also inquire about any known allergies, specifically to acetaminophen or any inactive ingredients in the product, before recommending its use for children. Patients should be instructed to discontinue use and consult a doctor if pain worsens or persists for more 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.

It is essential to emphasize that patients must not exceed the recommended dosage and to refer to the overdose warning for further guidance. Additionally, healthcare providers should advise patients to consult a doctor before use if their child has liver disease or is taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a package that includes a lot number and expiration date, which can be found on the bottom panel of the box. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Users are advised to retain the box for future reference regarding the lot number and expiration date.

Additional Clinical Information

The medication is administered orally, with each packet providing a single dose suitable for children weighing between 48 to 59 pounds or aged 6 to 8 years. Clinicians are advised to use weight for dosing when possible; otherwise, age may be used as a guide. Doses may be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period or be continued for more than 5 days without medical guidance.

Clinicians should counsel patients to consult a doctor before use if the child has liver disease or is taking warfarin, a blood-thinning medication. Patients should be instructed to discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

Drug Information (PDF)

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

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