Good Neighbor Pharmacy Pain and Fever

Description

Acetaminophen is presented as an oral suspension containing 160 mg of acetaminophen per 5 mL. This formulation is designed for the reduction of fever and relief of pain. It is free from aspirin, ibuprofen, alcohol, and parabens, making it suitable for a wide range of patients. The product is flavored with grape and is packaged in a 1 fl oz (30 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 healthcare professionals should refer to the dosing chart for appropriate administration. It is essential to shake the product well before use. The correct dose should be determined based on the child's weight; if weight is not available, age may be used as a guide.

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

1. Push air out of the enclosed syringe and insert 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. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is crucial not to exceed 5 doses in a 24-hour period.

For dosing specifics, refer to the following chart:

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

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

It is imperative to use only the enclosed syringe specifically designed for this product and to avoid using any other dosing device. After use, the cap should be replaced tightly to maintain child resistance. Healthcare professionals should also be aware that this product does not contain complete warnings for adult use and should not be administered in excess of the directed dosage.

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

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the maximum daily dosage is exceeded. Specifically, caregivers should be aware that administering more than five doses within a 24-hour period or combining this product with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include 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 two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Before administering this product, it is essential to consult a healthcare professional if the child has a history of liver disease. Additionally, caregivers should seek advice from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent.

Patients should discontinue use and consult a healthcare provider if new symptoms arise, if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, or if there is any redness or swelling, as these may indicate a serious underlying 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 aware of the risk 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 and seek immediate medical assistance.

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 promptly. Additionally, patients are advised to stop use and contact a doctor if new symptoms arise, if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, or if redness or swelling occurs, as these may indicate a serious underlying condition.

Before using this product, it is essential for patients with liver disease to consult a healthcare provider. Furthermore, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist prior to use.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222, even if no signs or symptoms are initially apparent, as prompt intervention is critical.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to ensure patient safety and efficacy of treatment. 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 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, as specific dosing recommendations are not provided for this age group. For children aged 2 to 3 years, the recommended dose is 5 mL for those weighing between 24 to 35 pounds, or as directed by a healthcare professional.

Caution is advised due to the presence of acetaminophen, which can lead to severe liver damage if more than 5 doses are taken within a 24-hour period. Additionally, acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, or rash. If any of these symptoms occur, use should be discontinued immediately, and medical assistance should be sought.

Parents and caregivers should consult a doctor before administering this product if the child has liver disease, has a history of allergic reactions to this product or its ingredients, or is taking the blood-thinning medication warfarin.

While using this product, it is crucial not to exceed the recommended dose. Caregivers should stop use and seek medical advice if new symptoms arise, if pain worsens or persists beyond 5 days, or if fever worsens or lasts more than 3 days. The presence of redness or swelling may indicate a serious condition requiring prompt medical evaluation.

In the event of an overdose, immediate medical help should be sought, or the Poison Control Center should be contacted at 1-800-222-1222, as quick medical attention is essential even if no signs or symptoms are apparent.

It is important to use only the enclosed syringe specifically designed for this product and to avoid using any other dosing devices.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. Healthcare providers should exercise caution and closely monitor geriatric patients for any adverse effects or complications that may arise due to the lack of specific guidance. It is advisable to assess the individual needs and health status of elderly patients before prescribing this product, as the absence of comprehensive information may necessitate dose adjustments or alternative therapeutic options.

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 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 thoroughly evaluated.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the mother is taking this medication while breastfeeding.

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. 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 the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals should be aware that quick medical attention can significantly impact the outcome of an overdose situation. Therefore, it is crucial to act swiftly, regardless of the presence of overt symptoms.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 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 presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this product if they have a history of allergic reactions to it or any of its ingredients. They should also be advised to discontinue use and consult a doctor if they experience new symptoms, if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, or if there is any redness or swelling, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage, as this could lead to overdose. Additionally, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease. It is also important to advise 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 a container that must be stored at a temperature range of 20-25°C (68-77°F). It is essential to ensure that the printed bottle wrap is intact; the product should not be used if the wrap is broken or missing. Proper handling and storage conditions are critical to maintaining the integrity 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 counsel patients to keep the medication out of reach of children and to seek immediate medical assistance in the event of an overdose, even if no symptoms are apparent. It is advised to consult a healthcare professional before use if the patient has liver disease or is taking warfarin. Patients should discontinue use and consult a doctor if new symptoms arise, if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, 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 Pain and Fever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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