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Good Sense 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 2011
Label revision date
May 21, 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 2011
Label revision date
May 21, 2024
Manufacturer
L. Perrigo Company
Registration number
M013
NDC root
0113-0946
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Acetaminophen is a medication commonly used to relieve minor aches and pains, such as those caused by the common cold, flu, headache, sore throat, and toothache. It also helps reduce fever, making it a popular choice for both children and adults. This particular formulation is an oral suspension that contains 160 mg of acetaminophen per 5 mL and is designed for children aged 2 to 3 years.

This product is alcohol-free, aspirin-free, ibuprofen-free, and paraben-free, and it comes in a pleasant grape flavor. It is comparable to the active ingredient found in Infants’ Tylenol® Oral Suspension, and it is recommended to use it with the enclosed syringe for accurate dosing.

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 provide you with relief when you're feeling under the weather, making it easier to manage your symptoms and feel more comfortable.

Dosage and Administration

Before using this product, make sure to shake the bottle well. To find the right dose for your child, refer to the dosing chart based on their weight or age. If your child weighs under 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 and aged 2 to 3 years, the recommended dose is 5 milliliters (mL).

When you're ready to measure the dose, push the air out of the syringe and insert the tip into the bottle opening. Flip the bottle upside down and pull the yellow part of the syringe to the first dose line, then push the liquid back into the bottle. Next, pull the yellow part of the syringe until it reaches the correct dose and stays there. Dispense the liquid slowly into your child's mouth, aiming for the inner cheek. You can repeat this dose every 4 hours as needed, but do not exceed 5 doses in a 24-hour period. Always use the enclosed syringe designed for this product and replace the cap tightly to keep it child-resistant.

What to Avoid

You should avoid using this product if your child has ever had an allergic reaction to it or any of its ingredients. Additionally, it is important not to use this product alongside any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you are uncertain whether a medication contains acetaminophen, please consult with a doctor or pharmacist for guidance.

Side Effects

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 containing acetaminophen. Be aware that acetaminophen may also cause serious 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.

It's important to consult a doctor if your child's sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, you should stop use and contact a 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. Always ask a doctor before use if your child has liver disease or is taking the blood thinner warfarin. In case of overdose, seek medical help or contact a Poison Control Center right away, as prompt attention is crucial.

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 containing acetaminophen. Be aware that acetaminophen may also cause serious 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. Additionally, if your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Before using this medication, it's important to ask a doctor if your child has liver disease or is taking the blood-thinning medication warfarin. In case of an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222, even if there are no immediate signs or symptoms. You should also stop using the product and call your doctor if your child's pain worsens or lasts more than 5 days, if their fever worsens or lasts more than 3 days, if new symptoms appear, or if there is any redness or swelling, as these could indicate a serious condition.

Overdose

Taking more than the recommended dose of medication can lead to an overdose, which is a serious situation. If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick action is crucial, even if you don’t see any signs or symptoms of an overdose.

To avoid the risk of overdose, always stick to the recommended dosage. Remember, your safety is the top priority, so if you have any doubts or concerns, don’t hesitate to reach out for help.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of acetaminophen during pregnancy has not been fully established. There may be potential risks to your developing baby, and more research is needed to understand these risks better. Therefore, you should consult your doctor before using acetaminophen.

If your healthcare provider recommends it, be aware that dosage adjustments might be necessary. Always use acetaminophen only if it is clearly needed and after discussing it with your healthcare professional to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding and considering using this product, it’s important to consult your doctor first. There is a possibility that the medication can pass into your breast milk, and the effects of acetaminophen on nursing infants have not been thoroughly studied. Because of this uncertainty, it’s wise to be cautious.

While using this medication, keep an eye on your baby for any unusual reactions or adverse effects. Your healthcare provider can help you weigh the benefits and risks to ensure the safety of both you and your child.

Pediatric Use

When giving this medication to your child, it's important to follow the dosing chart carefully. For children under 2 years old who weigh less than 24 pounds, you should consult a doctor before use. For those aged 2 to 3 years and weighing between 24 to 35 pounds, the recommended dose is 5 mL. Always use the enclosed syringe designed for this product to ensure accurate dosing.

Before administering the medication, check for any warnings. Do not use it if your child has had an allergic reaction to it or any of its ingredients. If your child has liver disease or is taking the blood thinner warfarin, consult a doctor or pharmacist before use. Following these guidelines will help ensure your child's safety and well-being.

Geriatric Use

When considering this medication for older adults, it's important to note that the product does not provide specific directions or complete warnings tailored for adult use. This means that if you or a loved one is an older adult, you should consult with a healthcare provider for personalized guidance. They can help ensure that the medication is safe and appropriate, taking into account any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare team to address any concerns or questions you may have.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

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 can help determine if this treatment is 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. Combining these medications can increase the risk of bleeding, so ensuring that your healthcare provider is aware of all medications your child is taking is crucial for their safety. Always prioritize open communication about any treatments or tests to avoid potential interactions.

Storage and Handling

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

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

Before using this medication for your child, consult a doctor if they have liver disease or are taking the blood thinner warfarin. If your child's pain worsens or lasts more than 5 days, or if a fever persists for more than 3 days, stop use and seek medical advice. Additionally, if new symptoms arise or if there is any redness or swelling, these could indicate a serious condition, and you should contact a doctor immediately.

FAQ

What is Acetaminophen used for?

Acetaminophen is a pain reliever and fever reducer that helps relieve minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

What is the recommended dosage for children aged 2-3 years?

For children aged 2-3 years weighing 24-35 lbs, the recommended dose is 5 mL. Always consult a doctor for children under 2 years.

How should I administer Acetaminophen?

Use only the enclosed syringe designed for this product. Shake well before use and dispense the liquid slowly into your child's mouth, toward the inner cheek.

What should I do if my child has a severe sore throat?

If your child's sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Are there any warnings associated with Acetaminophen?

Yes, do not exceed 5 doses in 24 hours, as this may cause severe liver damage. Also, stop use if a severe skin reaction occurs.

Can I use Acetaminophen if my child has liver disease?

You should ask a doctor before using Acetaminophen if your child has liver disease.

Is Acetaminophen safe to use during pregnancy?

The safety of Acetaminophen during pregnancy has not been established, so consult a doctor before use.

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.

What are the storage instructions for Acetaminophen?

Store Acetaminophen at 20-25°C (68-77°F) and do not use if the printed bottle wrap is broken or missing.

Packaging Info

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

Packaging configurations for Good Sense Pain and Fever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Acetaminophen is formulated as an oral suspension containing 160 mg of acetaminophen per 5 mL. This preparation is presented in a grape flavor and is designed to be alcohol-free, aspirin-free, ibuprofen-free, and paraben-free. The product adheres to a pediatrician preferred dosing system and is intended for use exclusively with the enclosed syringe. Each bottle contains 1 fluid ounce (30 mL) of the suspension, which is comparable to the active ingredient found in Infants’ 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

Healthcare professionals should ensure that the product is administered according to the following guidelines. Prior to use, the product must be shaken well. The dosing should be determined using the provided dosing chart, which recommends using the child's weight for dosing whenever possible; if weight is not available, age may be used as a secondary reference.

For administration, the following steps should be followed:

  1. Push air out of the syringe before inserting 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.

  4. Dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek.

The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period. For children weighing under 24 pounds or under 2 years of age, it is advised to consult a doctor for the appropriate dose. For children weighing between 24 and 35 pounds, the recommended dose is 5 mL.

It is imperative to use only the enclosed syringe specifically designed for this product; no other dosing devices should be utilized. After use, the cap should be replaced tightly to maintain child resistance. Healthcare professionals should also be aware that the product does not contain directions or complete warnings for adult use, and caution should be exercised to avoid exceeding the recommended dosage.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

  • This product should not be used in patients who have a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed five doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to mitigate the risk of liver injury.

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 without delay.

In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

Healthcare professionals should inquire about any pre-existing liver disease before recommending this product. Additionally, it is advisable to consult with a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant medication, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no symptoms are initially apparent.

Patients should be instructed to discontinue use and consult a healthcare provider 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 requiring further evaluation.

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 dosage 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 before use.

There is also an allergy alert associated with acetaminophen, as it may lead to 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 are advised to stop use and seek medical advice if pain worsens or lasts longer 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. In the event of an overdose, immediate medical help should be sought, or contact with a Poison Control Center (1-800-222-1222) is essential, as prompt medical attention is critical even if no signs or symptoms are initially 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 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 Sense Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Good Sense Pain and Fever.
Details

Pediatric Use

Pediatric patients under 2 years of age should not be given this product without consulting a doctor. For children aged 2 to 3 years who weigh between 24 to 35 pounds, the recommended dose is 5 mL, or as directed by a healthcare professional.

It is important to note that this product should not be used in children with a history of allergic reactions to it or any of its ingredients. Additionally, parents or caregivers should consult a doctor before administering this product if the child has liver disease or is taking the blood-thinning medication warfarin.

When determining the appropriate dose, it is advised to use the child's weight whenever possible; otherwise, age may be used as a guide. Caregivers must utilize only the enclosed syringe specifically designed for this product and should refrain from using any other dosing devices to ensure accurate administration.

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 essential 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

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus. Further studies are needed to determine the safety profile of acetaminophen in this population.

Dosage adjustments may be necessary, and it is essential for healthcare providers to offer recommendations tailored to individual circumstances. Acetaminophen should only be used if clearly needed and after a thorough discussion with a healthcare professional regarding the potential risks and benefits.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. 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 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 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 that healthcare professionals adhere to the recommended dosing guidelines, as exceeding the recommended dose can lead to serious health consequences.

Immediate medical assistance should be sought in cases of suspected overdose. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt medical attention is crucial, even if the patient does not exhibit any immediate signs or symptoms of overdose.

It is essential to monitor the patient closely and provide supportive care as necessary 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 use of the compound in these contexts.

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.

Healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, 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 a configuration that includes 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 packaging carefully; the product should not be used if the printed bottle wrap is broken or missing, as this may compromise the safety and quality of the product. Proper handling and storage conditions are crucial to ensure optimal performance and patient safety.

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 to exceed 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. Additionally, patients should be advised to 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 Sense 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 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.

Learn more in our Editorial Policy

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Primary FDA sources:

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.