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Good Sense Childrens Pain and Fever

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Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
May 6, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
May 6, 2024
Manufacturer
L. Perrigo Company
Registration number
M013
NDC root
0113-0608
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

GOOD SENSE® is a children's pain reliever and fever reducer designed for kids aged 2 to 11 years. It contains acetaminophen (160 mg per 5 mL) in an oral suspension form, providing fast and effective relief from minor aches and pains associated with common conditions like the cold, flu, headache, sore throat, and toothache. This product is alcohol-free, aspirin-free, and ibuprofen-free, making it a gentle option for your child's needs.

With its pleasant cherry flavor, GOOD SENSE® is formulated to help reduce fever and alleviate discomfort, ensuring your child feels better quickly. It is comparable to the active ingredient found in Children's Tylenol® Oral Suspension, making it a reliable choice for parents seeking effective pain and fever management for their children.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It is effective for discomfort caused by common conditions such as the cold and flu, as well as headaches, sore throats, and toothaches.

This medication is designed to make you feel more comfortable when you're dealing with these everyday ailments. If you're experiencing any of these symptoms, it may be a helpful option for you.

Dosage and Administration

Before using this product, make sure to shake it well. To find the right dose for your child, refer to the dosage chart based on their weight or age. If your child weighs less than 24 pounds or is under 2 years old, it's best to consult a doctor for the appropriate dose. For children weighing between 24 to 35 pounds (ages 2-3 years), the dose is 5 milliliters (mL). As the weight increases, so does the dose: 7.5 mL for 36-47 pounds (ages 4-5 years), 10 mL for 48-59 pounds (ages 6-8 years), 12.5 mL for 60-71 pounds (ages 9-10 years), and 15 mL for children weighing 72-95 pounds (age 11 years).

When administering the medication, remove the child protective cap and squeeze the correct dose into the dosing cup provided. You can repeat this dose every 4 hours as long as your child's symptoms persist, but remember not to exceed 5 doses in a 24-hour period. Always use the dosing cup that comes with the product, as other devices may not provide the correct measurement.

What to Avoid

You should avoid using this medication if you are taking any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. If you're unsure about a medication's ingredients, it's best to consult with your doctor or pharmacist. Additionally, do not use this product if your child has ever had an allergic reaction to it or any of its components.

It's also important to follow the recommended dosage carefully and not exceed it, as doing so can lead to serious health risks. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. There is a risk of severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Additionally, some individuals may experience severe skin reactions, such as skin reddening, blisters, or rashes. If any of these symptoms occur, stop using the medication and seek medical help immediately.

You should also consult a doctor if your child has a sore throat that is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. It's crucial to stop using the medication and seek medical advice if pain or fever worsens or lasts longer than the specified time frames, or if new symptoms arise. Always consult a doctor before use if your child has liver disease or is taking blood thinners like warfarin. In case of an overdose, seek medical help or contact a Poison Control Center right away, even if no symptoms are present.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications that also contain acetaminophen. It's important to be aware of potential severe skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

If your child has a sore throat that is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away. You should also stop using the product and call your doctor if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms appear, or if there is redness or swelling, as these could indicate a serious condition. In case of an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, even if no symptoms are present, as quick medical attention is crucial.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Even if you don’t notice any signs or symptoms, getting quick medical attention is crucial, as some effects may not be immediately apparent.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you experience any of these symptoms or have concerns about an overdose, don’t hesitate to reach out for help. Your safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this product during pregnancy. However, the insert does not indicate any known risks or contraindications associated with using acetaminophen while pregnant. Additionally, there are no dosage modifications recommended for pregnant individuals, and no special precautions are noted.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is between the ages of 2 and 11 years, this medication is recommended for them. However, it's important to follow the correct dosage based on their weight. For children under 24 pounds, you should consult a doctor before giving this medication. For those weighing between 24 and 95 pounds, the dosage varies: for 24-35 lb, give 5 mL; for 36-47 lb, 7.5 mL; for 48-59 lb, 10 mL; for 60-71 lb, 12.5 mL; and for 72-95 lb, 15 mL. You can repeat the dose every 4 hours as needed, but do not exceed 5 doses in a 24-hour period.

Be aware of some important safety concerns. Taking more than the recommended dose can lead to severe liver damage. Additionally, watch for any signs of severe skin reactions, such as redness, blisters, or rash. If your child has a sore throat that is severe, lasts more than 2 days, or is accompanied by other symptoms like fever or nausea, consult a doctor. Always check with a healthcare professional if your child has liver disease, is on blood thinners like warfarin, or has had allergic reactions to this medication before. If pain or fever worsens or lasts longer than the specified time, seek medical advice.

Geriatric Use

When considering this medication, it's important to note that it does not provide specific directions or complete warnings for adult use, including older adults. This means that if you or a loved one is an older adult, you should consult with a healthcare professional for personalized guidance.

Always ensure that any medication is appropriate for your health needs, especially if there are concerns about age-related changes in health or medication tolerance. Your healthcare provider can help determine the right dosage and monitor for any potential side effects.

Renal Impairment

If your child has liver disease, it's important to consult with a doctor before using this medication. This ensures that any potential risks are properly assessed and managed. Always prioritize your child's health by seeking professional guidance when it comes to their treatment options.

Hepatic Impairment

If your child has liver disease, it's important to consult with a doctor before using this medication. Liver disease can affect how the body processes medications, so your healthcare provider will help determine if it's safe and appropriate for your child. Always prioritize their health by seeking professional advice in these situations.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if your child is taking warfarin, a blood-thinning drug. Mixing these medications can lead to serious complications, so always check first.

Additionally, avoid using this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, don't hesitate to ask your healthcare provider for guidance. Keeping open communication about all medications helps ensure safety and effectiveness.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness. Before using the product, please check that the printed neckband is intact; do not use it if the neckband is broken or missing, as this could compromise safety.

By following these simple storage and handling guidelines, you can help ensure that your product remains safe and effective for use.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as needed while symptoms persist. However, do not exceed 5 doses in a 24-hour period. It's important to consult a doctor before use if your child has liver disease or is taking the blood thinner warfarin.

If your child's pain worsens or lasts more than 5 days, or if a fever worsens or lasts more than 3 days, stop using the medication and contact a doctor. Additionally, seek medical help immediately or call a Poison Control Center (1-800-222-1222) if an overdose is suspected, even if there are no noticeable symptoms. Always keep this medication out of reach of children.

FAQ

What is GOOD SENSE® used for?

GOOD SENSE® is a children's pain reliever and fever reducer, effective for ages 2 to 11 years. It helps reduce fever and relieve minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

What is the active ingredient in GOOD SENSE®?

The active ingredient in GOOD SENSE® is acetaminophen, with a concentration of 160 mg per 5 mL.

How should I dose GOOD SENSE® for my child?

Dosing depends on your child's weight and age. For example, a child weighing 24-35 lb (2-3 years) should receive 5 mL, while a child weighing 72-95 lb (11 years) should receive 15 mL.

Are there any warnings associated with GOOD SENSE®?

Yes, do not exceed the recommended dose, as severe liver damage may occur. Additionally, if your child has a severe sore throat, consult a doctor.

Can I give GOOD SENSE® to my child if they have liver disease?

You should ask a doctor before using GOOD SENSE® if your child has liver disease.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Is GOOD SENSE® safe for use during pregnancy or breastfeeding?

There is no specific information provided regarding the use of GOOD SENSE® during pregnancy or breastfeeding.

What flavors does GOOD SENSE® come in?

GOOD SENSE® is available in a cherry flavor.

What should I do if my child's symptoms do not improve?

If pain lasts more than 5 days or fever lasts more than 3 days, or if new symptoms occur, consult a doctor.

Packaging Info

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

Packaging configurations for Good Sense Childrens Pain and Fever.
Details

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.

View product document (PDF)

Description

GOOD SENSE® 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, serving as a pain reliever and fever reducer. The product is presented in a 4 FL OZ (118 mL) bottle and features a cherry 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 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 dosing chart provided, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative.

To administer the dose, the child protective cap should be removed, and the prescribed amount should be squeezed into the dosing cup provided. The dose may be repeated every 4 hours as needed while symptoms persist, but it is critical not to exceed 5 doses within a 24-hour period.

Dosage Chart:

  • For children weighing under 24 lb or under 2 years of age, consult a doctor for the appropriate dose.

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

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

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

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

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

Dosing should only be performed using the enclosed dosing cup specifically designed for this product; no other dosing devices should 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 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

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 5 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 is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may 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 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, 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 5 days, fever worsens or persists beyond 3 days, new symptoms develop, or if redness or swelling is observed. These symptoms may indicate the presence of a serious underlying condition that requires further evaluation.

In cases of suspected overdose, immediate medical attention is crucial. Patients or caregivers should be advised to contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as rapid intervention is essential for optimal outcomes.

Side Effects

Severe liver damage may occur in patients if more than 5 doses are taken within a 24-hour period, which is the maximum daily amount, or if the medication is used concurrently with other drugs containing acetaminophen. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. Additionally, patients should stop use and contact a doctor 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.

It is advised that patients consult a doctor prior to use if they have liver disease. Furthermore, patients taking the blood-thinning medication warfarin should seek guidance from a healthcare provider or pharmacist before using this product.

In cases of overdose, immediate medical help should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended. Quick medical attention is critical, even if no signs or symptoms are immediately apparent.

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 hepatotoxicity. 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.

Packaging configurations for Good Sense Childrens Pain and Fever.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years are recommended to use this medication. Dosing is based on weight and age, as follows: for children under 24 lb (under 2 years), consultation with a doctor is advised; for those weighing 24-35 lb (2-3 years), the dose is 5 mL; for 36-47 lb (4-5 years), the dose is 7.5 mL; for 48-59 lb (6-8 years), the dose is 10 mL; for 60-71 lb (9-10 years), the dose is 12.5 mL; and for 72-95 lb (11 years), the dose is 15 mL. Dosing may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period.

Safety concerns include a liver warning indicating that severe liver damage may occur if the recommended dose is exceeded. An allergy alert is also present, as acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, and rash. Additionally, a sore throat warning advises consulting a doctor if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Healthcare professionals should advise parents or guardians to consult a doctor if the child has liver disease, is taking the blood-thinning medication warfarin, has a history of allergic reactions to this product or its ingredients, experiences worsening pain lasting more than 5 days, has a fever that worsens or lasts more than 3 days, or if new symptoms arise, including redness or swelling.

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

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 evaluate the patient's overall health status and renal function to determine the appropriateness of treatment and any necessary dosing adjustments. Monitoring of renal function may be warranted to ensure safety and efficacy in this population.

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. It is crucial to monitor the patient closely and provide supportive care as needed while awaiting further medical guidance.

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 compound in these areas.

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Good Sense Childrens Pain and Fever, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.