Basic Care Infants Pain and Fever

Description

Acetaminophen is provided in a suspension liquid form, delivering 160 mg of acetaminophen per 5 mL. This formulation serves as a pain reliever and fever reducer, and is specifically designed to be free from aspirin, ibuprofen, alcohol, parabens, and dyes. The product features a cherry flavor for palatability. It is packaged in a 2 FL OZ (59 mL) container and is intended for use with the enclosed syringe.

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

This product is intended for pediatric use only and does not contain complete directions or warnings for adult use. Healthcare professionals should ensure that the dosage is not exceeded, adhering to the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose can be determined using the provided dosing chart, which recommends using the child's weight for dosing whenever possible; otherwise, age may be used as a guide.

To prepare the dose, the following steps should be followed:

1. Push the air out of the syringe before inserting the syringe tip into the bottle opening.

2. Invert the bottle and pull the yellow part of the syringe to the first dose line, then push the product back into the bottle.

3. Pull the yellow part of the syringe until it reaches and remains 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 within a 24-hour period.

It is essential to replace the cap tightly after use to maintain child resistance. Only the enclosed syringe specifically designed for use with this product should be utilized; no other dosing devices are permitted.

For specific dosing recommendations, refer to the dosing chart:

• For children weighing under 24 lb or under 2 years of age, the dose is to be determined by a doctor.

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

*Dosing may also be as directed by a healthcare professional.

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 history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within a 24-hour period or if they are concurrently using other medications that also contain acetaminophen. Healthcare professionals should advise caregivers to strictly adhere to dosing guidelines to mitigate the risk of liver injury.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

Healthcare professionals should instruct caregivers to stop use and consult a doctor if the child experiences worsening pain lasting more than 5 days, fever that worsens or persists beyond 3 days, the emergence of new symptoms, or any signs of redness or swelling, as these may indicate a serious medical issue.

In the event of an overdose, immediate medical attention is crucial. Caregivers should be advised to contact a Poison Control Center at 1-800-222-1222, even if no signs or symptoms are apparent, as timely intervention can be critical.

Before administering this product, it is essential to consult a healthcare provider if the child has a history of liver disease. Additionally, caregivers should seek advice from a doctor or pharmacist if the child is currently taking the anticoagulant medication warfarin, as potential interactions may necessitate closer monitoring.

When using this product, it is vital to adhere to the recommended dosage to prevent overdose.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum recommended dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen.

Patients may also experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Additionally, a warning is issued for patients experiencing a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting; such symptoms warrant prompt consultation with a healthcare provider.

Patients should be advised to stop use and consult a doctor if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious underlying condition.

It is recommended that patients with liver disease consult a doctor prior to use. Furthermore, patients taking the anticoagulant warfarin should seek advice from a healthcare professional or pharmacist before using this product.

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 Basic Care Infants Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not be given this medication without consulting a healthcare professional. For children aged 2 to 3 years who weigh between 24 to 35 pounds, the recommended dose is 5 mL, or as directed by a doctor.

It is crucial to adhere strictly to the dosing guidelines, as exceeding the recommended dose can lead to serious health risks. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, even if no symptoms are apparent.

Parents and caregivers are advised to keep this medication out of reach of children and to use only the enclosed syringe specifically designed for this product for accurate dosing. Other dosing devices should not be used to prevent dosing errors.

Geriatric Use

Elderly patients may not receive adequate guidance regarding the use of this product, as it does not contain directions or complete warnings specifically for adult use. Healthcare providers should exercise caution when considering this product for geriatric patients, as the lack of comprehensive information may impact safety and efficacy. It is advisable to closely monitor elderly patients for any adverse effects and to consider alternative therapies that provide clearer dosing and safety information.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients. The absence of safety concerns, dosage modifications, or special precautions in the labeling indicates a lack of comprehensive clinical or animal study data to inform risk assessment. Therefore, healthcare providers are encouraged to weigh the potential benefits against any unknown risks when considering acetaminophen for women of childbearing potential. It is advisable to discuss the use of this medication with patients who are pregnant or planning to become pregnant to ensure informed decision-making.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence 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 patients 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. Close monitoring of liver function tests may be warranted 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. It is crucial to emphasize that prompt medical attention is necessary, even if the patient does not exhibit any signs or symptoms of overdose.

Patients should be instructed not to exceed the recommended dose, as doing so may lead to serious health risks.

Additionally, healthcare providers should encourage patients to consult with a doctor before using this medication if their child has liver disease. It is also important to recommend that patients speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin, to avoid potential interactions.

Storage and Handling

This product is supplied in a specific packaging configuration, which includes an enclosed syringe designed exclusively for its use. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to ensure its efficacy and safety.

Healthcare professionals should ensure that the product is not used if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's integrity. Additionally, to maintain child resistance, the cap must be replaced tightly after each use. Proper handling and adherence to these guidelines are crucial for the safe administration of the product.

Additional Clinical Information

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 anticoagulant warfarin. Patients should also 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, if new symptoms arise, or if there is any redness or swelling.

Drug Information (PDF)

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

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