Good Neighbor Pharmacy Infants Pain and Fever

Description

Acetaminophen is presented as an oral suspension containing 160 mg of acetaminophen per 5 mL. This formulation is designed to provide effective relief from fever and pain. The product is free from aspirin, ibuprofen, alcohol, parabens, and dyes, ensuring a gentle option for patients. It is flavored with grape to enhance palatability. Each bottle contains 2 fl oz (60 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

This product is intended for pediatric use only, and healthcare professionals should ensure that dosing is based on the child's weight whenever possible. If weight is not available, age may be used as a secondary guide.

Prior to administration, the product must be shaken well. The appropriate dose can be determined using the dosing chart provided. For children weighing under 24 pounds or under 2 years of age, it is advised to consult a doctor for the appropriate dosage. For children weighing between 24 and 35 pounds, or aged 2 to 3 years, the recommended dose is 5 mL.

To prepare the dose, healthcare professionals should follow these steps:

1. Use only the enclosed syringe specifically designed for this product; do not substitute with any other dosing device.

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

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

4. 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 in a 24-hour period. After use, ensure that the cap is replaced tightly to maintain child resistance.

Healthcare professionals should be aware of the overdose warning and ensure that the product is not administered beyond the recommended limits.

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.

Additionally, this product is contraindicated in patients who have a history of allergic reactions to this product or any of its components.

Exceeding the recommended dosage is also contraindicated due to the risk of overdose.

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 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 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. Additionally, it is essential to consult 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 any of the following occur: worsening pain that lasts more than 5 days, worsening fever that persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious condition.

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 it is taken concurrently with other medications containing acetaminophen. Patients with liver disease should consult a doctor before use.

There is also an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients should discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a doctor promptly.

Patients should stop using the product and seek medical advice if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Additionally, it is important for patients to consult a doctor or pharmacist before use if they are taking the blood-thinning medication warfarin. Patients are cautioned not to exceed the recommended dose, and in the event of an overdose, immediate medical help should be sought or contact with a Poison Control Center should be made at 1-800-222-1222. Quick medical attention is critical, even if no signs or symptoms are present.

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. Patients are advised to verify the presence of acetaminophen in other medications by consulting a healthcare provider or pharmacist to avoid unintentional overdose.

Packaging & NDC

Below are the non-prescription pack sizes of Good Neighbor Pharmacy Infants Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 24 months should consult a doctor before use. For children aged 24 to 35 months (2-3 years), the recommended dose is 5 mL. It is advised to use weight for dosing when possible; otherwise, age may be used as a guide.

Administration should not exceed 5 doses within a 24-hour period, and the recommended dose must not be surpassed. In cases where the child has liver disease or is taking the blood-thinning medication warfarin, consultation with a doctor or pharmacist is necessary prior to use.

Healthcare professionals should advise caregivers to discontinue use and seek medical attention if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, or if new symptoms arise. Additionally, the presence of redness or swelling may indicate a serious condition that requires immediate medical evaluation.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. The use of this product is not recommended during pregnancy unless directed by a healthcare provider. There may be potential risks to the fetus associated with the use of acetaminophen during this period.

If the use of acetaminophen is deemed necessary, pregnant patients should consult their healthcare provider for appropriate dosing modifications. It is essential for pregnant women to discuss the use of this medication with their healthcare provider to weigh the benefits against potential risks.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been identified in the available information.

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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 medical intervention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented to mitigate potential complications associated with the overdose.

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.

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.

Providers should also instruct patients not to exceed the recommended dose, highlighting the importance of adhering to dosage guidelines to prevent potential overdose.

Additionally, healthcare providers should encourage patients to consult with a doctor before using the medication if their child has liver disease. This precaution is essential to ensure the safety and appropriateness of the treatment.

Furthermore, it is important for healthcare providers to recommend that patients speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin. This discussion is vital to avoid any potential interactions that could compromise the child's health.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity 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 safety. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for patient use.

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 counsel patients to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. Patients should 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, as these may indicate a serious condition.

Drug Information (PDF)

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

View product document (PDF)