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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
April 30, 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
April 30, 2024
Manufacturer
L. Perrigo Company
Registration number
M013
NDC root
0113-0161
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Acetaminophen is a medication commonly used to relieve pain and reduce fever in infants. It comes in a cherry-flavored oral suspension that is alcohol-free, aspirin-free, ibuprofen-free, and paraben-free, making it a safe choice for young children. This medication is effective for alleviating minor aches and pains associated with conditions like the common cold, flu, headaches, sore throats, and toothaches.

Typically, acetaminophen is dosed using an enclosed syringe, and it is designed for children aged 2 to 3 years. With a concentration of 160 mg per 5 mL, it is comparable to the active ingredient found in Infants’ Tylenol® Oral Suspension, making it a trusted option for parents seeking relief for their little ones.

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 safe in terms of teratogenic effects, meaning it does not cause birth defects. You can feel confident using it for relief from these common ailments.

Dosage and Administration

Before you use this medication, it's important to know that it doesn't come with complete instructions for adult use. Always follow the recommended dosage and never give more than directed, as taking too much can be harmful. Start by shaking the bottle well to ensure the medication is mixed properly.

To measure the right dose, refer to the dosing chart provided. If possible, use your child's weight for a more accurate measurement; otherwise, you can use their age. To prepare the dose, push the air out of the syringe, insert the syringe tip into the bottle opening, and flip the bottle upside down. 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. When giving the medication, dispense it slowly into your child's mouth, aiming for the inner cheek. You can repeat this dose every 4 hours while symptoms last, 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. If you have any questions or concerns, consult your doctor.

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 whether a medication contains acetaminophen, please consult 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 ingredients.

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

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. Additionally, be aware that acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. If any of these symptoms occur, stop using the product and seek medical help immediately.

You should also consult a doctor if your child experiences a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting. It's important to stop use and contact a doctor if new symptoms arise, if pain worsens or lasts more than 5 days, or if fever persists for more than 3 days. 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 assistance or contact a Poison Control Center right away, as prompt attention is crucial.

Warnings and Precautions

It's important to be aware of some key warnings when using this product, which contains acetaminophen. Taking more than 5 doses in 24 hours can lead to severe liver damage, especially if combined with other medications that also contain acetaminophen. Additionally, be cautious 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 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 product, it's wise to check with 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 no symptoms are present. You should also stop using the product and call your doctor if new symptoms arise, if pain worsens or lasts more than 5 days, if fever increases or lasts more than 3 days, or if there is any redness or swelling, as these could indicate a serious condition.

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. Quick action is crucial, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in your safety and health.

Pregnancy Use

You can generally use acetaminophen during pregnancy, as there are no specific warnings or precautions mentioned regarding its use. The information provided does not indicate that acetaminophen is contraindicated (not recommended) for pregnant individuals, nor does it highlight any risks to the fetus. Additionally, there are no dosage modifications or special precautions required for those who are pregnant.

However, it's always a good idea to consult with your healthcare provider before taking any medication during pregnancy to ensure it’s safe 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.

If you do take this medication while nursing, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help guide you on the best practices to ensure both your health and your infant's well-being.

Pediatric Use

When giving this medication to your child, it's important to follow the dosing guidelines 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.

Be aware of some important warnings. This medication contains acetaminophen, which can cause severe liver damage if your child takes more than 5 doses in a 24-hour period. Additionally, watch for any signs of an allergic reaction, such as skin redness, blisters, or rash, and seek medical help immediately if these occur. If your child has a severe sore throat that 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 or a history of allergic reactions to this product.

Geriatric Use

When considering this product, 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 before using this product to ensure it is safe and appropriate for your needs. Always prioritize clear communication with your doctor about any medications or treatments you are considering.

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 managed and that the treatment is safe for your child's specific health needs. Always prioritize open communication with your healthcare provider regarding any existing health conditions.

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 this treatment is safe and appropriate for your child. Always prioritize their health by seeking professional guidance 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 has acetaminophen, don't hesitate to ask a healthcare professional for guidance. Keeping open communication with your healthcare provider helps ensure safe and effective treatment.

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. Before using, always check that the printed bottle wrap is intact; do not use the product if the wrap is broken or missing, as this could compromise its 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 long as symptoms persist, but do not exceed 5 doses in a 24-hour period. If your child has liver disease or is taking the blood-thinning medication warfarin, consult a doctor or pharmacist before use.

It's important to stop using the medication and seek medical advice if new symptoms arise, if pain worsens or lasts more than 5 days, if fever increases or lasts more than 3 days, or if there is any redness or swelling.

FAQ

What is Acetaminophen used for?

Acetaminophen is used to reduce fever and 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 the dosing chart or a doctor for proper dosing.

How should I administer Acetaminophen to my child?

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

What should I do if my child experiences a skin reaction?

If your child develops symptoms like skin reddening, blisters, or rash, stop using Acetaminophen and seek medical help immediately.

Are there any warnings associated with Acetaminophen?

Yes, do not exceed 5 doses in 24 hours, as this can lead to severe liver damage. Consult a doctor if new symptoms occur or if pain or fever persists.

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 provided information does not mention specific risks or contraindications for use during pregnancy, but it is advisable to consult a doctor.

What should I do in case of an overdose?

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

How should I store Acetaminophen?

Store Acetaminophen at 20-25°C (68-77°F) and do not use it 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 designed for pediatric use and adheres to a Pediatrician Preferred Dosing System. The product is alcohol-free, aspirin-free, ibuprofen-free, and paraben-free, ensuring a safer option for infants and children. It is presented in a cherry flavor to enhance palatability. 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. Dosing should be determined using the provided dosing chart, with preference given to weight-based dosing; if weight is not available, age may be used as a secondary reference.

For administration, the following steps should be followed:

  1. Prepare the syringe by pushing air out of it.

  2. Insert the syringe tip into the bottle opening and flip the bottle upside down.

  3. Pull the yellow part of the syringe to the first dose line, then push the product back into the bottle.

  4. Pull the yellow part of the syringe until it reaches and remains at the correct dose.

  5. 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. Specific dosing recommendations based on weight and age are as follows:

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

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

It is imperative not to exceed the recommended dosage, and to replace the cap tightly after use to maintain child resistance. Only the enclosed syringe specifically designed for use with this product should be utilized; no other dosing devices are permitted.

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 adverse reactions.

  • Exceeding the recommended dose 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. Healthcare professionals should advise caregivers that exceeding five doses within a 24-hour period, which constitutes the maximum daily amount, or concomitant use with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions 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 two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

Healthcare professionals should advise caregivers to consult a physician prior to administration if the child has a history of liver disease. Additionally, it is prudent to seek guidance 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 be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Caregivers should be advised to 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 redness or swelling occurs, as these may indicate a serious underlying condition.

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 liver disease should consult a doctor before 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 should 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 are advised to consult a doctor promptly.

Patients should stop use and seek medical advice if new symptoms arise, if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, or if redness or swelling is observed, as these may indicate a serious condition.

Additionally, it is important for patients to consult a doctor or pharmacist 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 recommended, as prompt medical attention is critical even if no signs or symptoms are initially present.

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 any 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 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 who weigh less than 24 pounds should consult a doctor before use. For children aged 2 to 3 years weighing between 24 and 35 pounds, the recommended dosage is 5 mL.

Caution is advised due to potential risks associated with acetaminophen. Severe liver damage may occur if more than 5 doses are taken within a 24-hour period, which is the maximum daily amount. Additionally, acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, or rash. If any skin reaction occurs, 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 or has previously experienced an allergic reaction to this product or any of its ingredients.

While using this product, it is crucial not to exceed the recommended dose. If new symptoms arise, if pain worsens or persists beyond 5 days, or if fever worsens or lasts more than 3 days, or if redness or swelling is observed, a doctor should be consulted promptly, as these may indicate a serious condition.

To ensure accurate dosing, caregivers should refer to the dosing chart and, if possible, use the child's weight for dosage determination; otherwise, age may be used. Only the enclosed syringe specifically designed for this product should be utilized for dosing; other devices are not recommended.

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

Acetaminophen is not associated with specific warnings or precautions for use during pregnancy. The available data does not indicate that the product is contraindicated in pregnant patients, nor does it suggest any known risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for individuals who are pregnant. Healthcare professionals should consider the overall clinical context when advising pregnant patients on the use of acetaminophen.

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 a nursing infant 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 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 is 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 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 is critical in managing overdose situations. Even in the absence of overt symptoms, the risk of delayed reactions necessitates thorough evaluation and monitoring of the patient.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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.

Patients must be cautioned against using 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.

It is essential to inform patients that this product should not be used if their child has a history of allergic reactions to it or any of its ingredients. Patients should be instructed to discontinue use and consult a doctor if new symptoms arise, if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, or if any redness or swelling occurs, as these may indicate a serious condition.

While using this product, patients should be reminded not to exceed the recommended dosage, in line with the overdose warning. Additionally, healthcare providers should advise patients to seek medical advice before use if their child has liver disease or 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 prior to use; the product should not be utilized 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

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 advise patients to consult a doctor prior to use if the child has liver disease or is concurrently taking warfarin, a blood-thinning medication. Patients should be instructed to discontinue use and seek medical advice if new symptoms arise, if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, or if any redness or swelling occurs.

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.