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 grape flavor for palatability. It is packaged in a 2 FL OZ (59 mL) container and is intended for use with the enclosed syringe, with additional information available on the side panel.

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 should be determined using the dosing chart provided, with weight being the preferred method for dosing; if weight is not available, age may be used as a secondary reference.

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

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

2. Flip the bottle upside down 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 stays at the correct dose.

The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek. The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 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 to 35 pounds and aged 2 to 3 years, the recommended dose is 5 mL.

It is crucial to use only the enclosed syringe specifically designed for this product; no other dosing device should be utilized. After use, the cap must be replaced tightly to maintain child resistance.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

• This product should not be used in patients who have 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 dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen.

Acetaminophen has been associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a 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 if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should inquire about the presence of liver disease before recommending this product for use in children. Additionally, it is essential to consult with a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent.

Patients should be advised to discontinue use and contact a healthcare provider 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, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with the use of this product include the potential for severe liver damage, particularly if a child exceeds five doses within a 24-hour period, which is the maximum recommended daily amount. Additionally, the risk of severe liver damage increases if this product is taken concurrently with other medications containing acetaminophen.

Patients should be aware of the possibility of 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.

A warning regarding sore throat is also pertinent; if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional without delay.

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

It is recommended that a healthcare provider be consulted prior to use if the child has a history of liver disease. Furthermore, consultation with a doctor or pharmacist is advised if the child is currently taking the blood-thinning medication warfarin.

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. 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 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 product without consulting a doctor. 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 healthcare professional.

It is important to note that this product should not be used in pediatric patients with a history of allergic reactions to it or any of its ingredients. Additionally, a healthcare provider should be consulted prior to use if the child has liver disease or is taking the anticoagulant warfarin.

When administering the medication, caregivers should refer to the dosing chart to determine the appropriate dose based on the child's weight, if possible; otherwise, age may be used as a guide. Only the enclosed syringe specifically designed for this product should be utilized for dosing; other devices are not recommended.

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.

Pregnancy

There is no specific information available regarding the use of this product during pregnancy. The prescribing information does not mention any contraindications or risks associated with the use of acetaminophen during this period. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

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 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. 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 may be warranted to ensure safety and efficacy in this 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

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 while symptoms persist, not exceeding 5 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor before use if the patient has liver disease or is taking the anticoagulant warfarin. Patients are advised 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. It is crucial to keep the medication out of reach of children, and in the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222, as prompt attention is essential even if no symptoms are apparent.

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.

View product document (PDF)