Parents Choice Infants Pain and Fever

Description

Acetaminophen is a pediatric pain reliever and fever reducer formulated as a suspension liquid. Each 5 mL dose contains 160 mg of acetaminophen, making it suitable for children aged 2 to 3 years. This product is free from ibuprofen, aspirin, alcohol, and parabens, and features a dye-free grape flavor. The total volume of the product is 2 FL OZ (59 mL). It is recommended to use the enclosed syringe for dosing, and further information can be found on the side panel. The dosing system is preferred by pediatricians.

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

Healthcare professionals should ensure that the product is administered according to the following guidelines. Prior to use, the product must be shaken well. The dosing should be determined using the provided dosing chart, which recommends using the child's weight for dosing whenever possible; if weight is not available, age may be used as an alternative.

For administration, the enclosed syringe specifically designed for this product must be utilized. Other dosing devices are not recommended. To prepare the dose, push air out of the syringe and insert the syringe tip into the bottle opening. The bottle should then be flipped upside down. Pull the yellow part of the syringe to the first dose line, then push the product back into the bottle. Next, pull the yellow part of the syringe until it reaches and stays at the correct dose.

The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek. Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses in a 24-hour period.

For specific dosing based on weight and age:

• For children weighing under 24 pounds or under 2 years of age, consult a doctor for the appropriate dose.

• For children weighing between 24 and 35 pounds, or aged 2 to 3 years, the recommended dose is 5 mL.

It is imperative to replace the cap tightly after use to maintain child resistance. Additionally, healthcare professionals should advise caregivers not to exceed the recommended dosage and to refer to the overdose warning for further guidance.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

This product is contraindicated in patients with a known history of allergic reactions to this product or any of its components.

Additionally, it is essential to adhere to the recommended dosage, as exceeding this may lead to overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the child exceeds five doses within a 24-hour period, the maximum daily amount. Additionally, the risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is advised.

General precautions necessitate that healthcare providers inquire about the child’s medical history, particularly regarding liver disease, prior to recommending this product. Furthermore, it is essential to consult a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

In cases of overdose, immediate medical attention is critical. Healthcare professionals should instruct caregivers to contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent.

Patients should be advised to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond five days, fever worsens or lasts more than three days, new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be advised of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, immediate cessation of use and prompt medical attention are necessary.

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 without delay.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients with a known allergy to this product or any of its ingredients should also refrain from use. Additionally, it is important for patients with liver disease to seek medical advice prior to using this product. Caution is advised for those taking the anticoagulant warfarin, and consultation with a healthcare provider or pharmacist is recommended.

During the use of this product, patients must adhere to the recommended dosage to avoid overdose. If pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, or if new symptoms arise, patients should discontinue use and consult a doctor. Signs of redness or swelling should also prompt immediate medical evaluation, as these may indicate a serious condition.

In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as timely intervention is crucial even in the absence of noticeable symptoms.

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 other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose may be heightened, leading to serious hepatic complications. 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 Parents Choice Infants Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 24 pounds and under 2 years of age should be advised to consult a doctor before administration. For pediatric patients weighing between 24 to 35 pounds and aged 2 to 3 years, the recommended dose is 5 mL.

It is essential to utilize the enclosed syringe specifically designed for this product for accurate dosing. The use of any other dosing device is not recommended.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. As such, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are adequately assessed.

Lactation

There is no specific information available regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication.

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 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 essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful evaluation and ongoing monitoring may be necessary to ensure safety and efficacy in this patient population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential, as quick medical attention can significantly impact the outcome, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious complications. Therefore, monitoring and evaluation should be conducted as soon as possible following an overdose incident.

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 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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing that prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dose, as doing so may lead to serious health risks. It is important for healthcare providers to inquire about any existing liver disease in children before recommending use of the medication. Additionally, patients should be advised to consult with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin.

Healthcare providers should inform patients to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients must be cautioned against using this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be encouraged to seek clarification from a healthcare professional.

Finally, healthcare providers should ensure that patients are aware that this medication should not be used if their child has a history of allergic reactions to this product or any of its ingredients.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed neckband is broken or missing, as this may indicate potential tampering or compromise of the product's integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended repeat dose every 4 hours as needed, not to exceed 5 doses within a 24-hour period.

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

Drug Information (PDF)

This file contains official product information for Parents Choice Infants Pain and Fever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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