Good Neighbor Pharmacy Childrens Pain and Fever

Description

Acetaminophen oral suspension contains 160 mg of acetaminophen per 5 mL. This formulation is designed as a fever reducer and pain reliever. It is free from aspirin, ibuprofen, alcohol, and parabens. The product is presented in a bubble gum flavor and is packaged in a 4 fl oz (118 mL) bottle.

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 directions or complete 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 dosage chart below, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative.

To administer the dose, remove the child protective cap and squeeze the prescribed amount into the enclosed dosing cup. The dose may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period.

Dosage 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 24-35 lb or aged 2-3 years, the dose is 5 mL.

• For children weighing 36-47 lb or aged 4-5 years, the dose is 7.5 mL.

• For children weighing 48-59 lb or aged 6-8 years, the dose is 10 mL.

• For children weighing 60-71 lb or aged 9-10 years, the dose is 12.5 mL.

• For children weighing 72-95 lb or aged 11 years, the dose is 15 mL.

*Dosing should be as directed by a doctor when necessary.

It is imperative to use only the enclosed dosing cup specifically designed for this product; other dosing devices should not be utilized.

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.

• Exceeding the recommended dosage is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Acetaminophen may also trigger severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, a prompt consultation with a physician is recommended.

Patients should be instructed to stop use and consult a healthcare professional if any of the following occur: pain worsens or lasts longer than five days, fever worsens or persists beyond three days, new symptoms develop, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires further evaluation.

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

Prior to administration, it is essential to consult a physician if the patient has a history of liver disease. Furthermore, healthcare professionals should advise caution and recommend consultation with a doctor or pharmacist if the patient is concurrently taking the anticoagulant warfarin, as interactions may occur.

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 pre-existing liver disease should consult a doctor prior to 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 are advised 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 fever, headache, rash, nausea, or vomiting, patients should 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 recommended that patients consult a healthcare professional before use if they are 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 necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to 11 years, dosing is based on weight: 5 mL for those weighing 24-35 lb (2-3 years), 7.5 mL for 36-47 lb (4-5 years), 10 mL for 48-59 lb (6-8 years), 12.5 mL for 60-71 lb (9-10 years), and 15 mL for those weighing 72-95 lb (11 years).

It is crucial not to exceed the recommended dose, and administration should not occur more than five times within a 24-hour period. Prior to use, a healthcare professional should be consulted if the child has a history of allergic reactions to this product or its ingredients, has liver disease, or is taking the anticoagulant warfarin.

Parents and caregivers should seek medical advice if the child experiences a severe sore throat that persists for more than 2 days, is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, they should stop use and consult a doctor if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms develop, or if redness or swelling occurs.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt attention is critical even if no symptoms are apparent. It is important to use only the enclosed dosing cup specifically designed for this product and to avoid using any other dosing device.

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 prescribing this product to geriatric patients, considering the potential for inadequate information on safety and efficacy in this population. It is essential to monitor these patients closely and assess their individual needs, as the absence of tailored guidance may impact treatment outcomes.

Pregnancy

There is no specific information available regarding the use of Good Neighbor Pharmacy Children's Pain and Fever (acetaminophen suspension) during pregnancy. Consequently, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in women of childbearing potential. It is advisable to consult relevant clinical guidelines and consider alternative therapies when necessary.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no considerations or precautions mentioned concerning lactation or the potential for excretion in breast milk. Therefore, healthcare professionals may consider the use of this product in lactating mothers without specific concerns related to breastfeeding.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a concurrent liver disease. It is essential to assess the patient's overall renal function and consider any necessary dosing adjustments or monitoring protocols based on the severity of renal impairment.

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 the safe and effective use of the medication 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 possibility of serious complications. Therefore, monitoring and evaluation should be conducted as soon as an overdose is suspected. It is crucial to follow established protocols for managing overdose cases, which may include supportive care and symptomatic treatment as necessary.

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 revealed reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical attention in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222, as prompt medical intervention is crucial, even if no signs or symptoms are apparent.

It is essential to instruct patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of a medication, they should be encouraged to consult with a doctor or pharmacist for clarification.

Patients should be made aware that this product should not be used if their child has a history of allergic reactions to it or any of its ingredients. Additionally, healthcare providers should counsel patients to discontinue use and seek medical advice if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage, in line with the overdose warning. Furthermore, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease. It is also advisable for patients to speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin.

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 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 Good Neighbor Pharmacy Childrens Pain and Fever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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