Good Sense Childrens Pain and Fever

Description

GOODSENSE® is an oral suspension formulated for children aged 2 to 11 years, providing effective relief from pain and fever. Each 5 mL dose contains 160 mg of acetaminophen. The product is presented in an 8 FL OZ (236 mL) bottle and features a grape flavor. It is free from alcohol, aspirin, ibuprofen, and parabens, ensuring a safe option for pediatric use. This formulation is comparable to the active ingredient found in Children’s Tylenol® Oral 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 refer to the dosage chart to determine the appropriate dose based on the child's weight or age. Prior to administration, the product must be shaken well to ensure proper mixing.

To administer the dose, the child protective cap should be removed, and the appropriate amount of liquid should be squeezed into the enclosed dosing cup. The recommended dosing intervals are every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period.

The following dosage chart provides specific dosing recommendations:

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

It is imperative to adhere strictly to the dosing recommendations and not exceed the maximum dosage to avoid the risk of overdose. Only the enclosed dosing cup should be used for measurement; other dosing devices are not appropriate for this product.

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 a medication, 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 dose is contraindicated, as it poses a 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 is associated with the risk of 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 children. 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 consult 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 present, 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 recommended dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be advised of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, immediate discontinuation of the product and prompt medical attention are necessary.

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 without delay.

It is contraindicated to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Additionally, patients with a known allergy to acetaminophen or any of its ingredients should not use this product.

Before using this product, patients with liver disease should seek medical advice. Furthermore, those taking the anticoagulant warfarin should consult a healthcare provider or pharmacist prior to use.

During the use of this product, patients must adhere to the recommended dosage to avoid overdose. They should discontinue use and consult a doctor if pain worsens or persists beyond five days, if fever worsens or lasts more than three days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, it is critical to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential even in the absence of noticeable signs or symptoms.

This product should be kept out of reach of children to prevent accidental ingestion.

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 Good Sense 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 3 years weighing 24-35 lb, the recommended dose is 5 mL; for those aged 4 to 5 years weighing 36-47 lb, the dose is 7.5 mL; for children aged 6 to 8 years weighing 48-59 lb, the dose is 10 mL; for those aged 9 to 10 years weighing 60-71 lb, the dose is 12.5 mL; and for 11-year-olds weighing 72-95 lb, the dose is 15 mL. Dosing should be based on weight when possible; otherwise, age may be used. Doses may be repeated every 4 hours while symptoms persist, but no more than 5 doses should be given in a 24-hour period.

Severe liver damage may occur if more than 5 doses are taken within 24 hours. Acetaminophen may also cause severe skin reactions, including skin reddening, blisters, or rash; if any of these symptoms occur, use should be discontinued immediately, and medical help should be sought. Parents should consult a doctor if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, a doctor should be consulted before use if the child has liver disease or is taking the blood-thinning medication warfarin.

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

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

There is no specific information available regarding the use of Good Sense Children's Pain and Fever (acetaminophen suspension) during pregnancy. As such, 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 during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

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.

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 evaluate 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 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 to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing that prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients must be cautioned against exceeding the recommended dose, as this could lead to overdose. Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, patients should be advised to speak with a doctor or pharmacist prior to use 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. 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 compromised 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 child has liver disease or is taking the blood-thinning medication warfarin. They should also advise that if a sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly. Patients should discontinue use 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 occurs. In the event of an overdose, immediate medical assistance should be sought, and the Poison Control Center can be contacted at 1-800-222-1222, as prompt attention is crucial even if no symptoms are apparent.

Drug Information (PDF)

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

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