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Feverall

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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 2023
Label revision date
July 2, 2025
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 2023
Label revision date
July 2, 2025
Manufacturer
Sun Pharmaceutical Industries, Inc.
Registration number
M013
NDC root
51672-5319
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

FeverAll is a cherry-flavored oral suspension designed for children ages 2 to 11 years. It contains acetaminophen (160 mg per 5 mL), which is a medication commonly used to relieve pain and reduce fever. FeverAll is effective for alleviating minor aches and pains associated with conditions such as the common cold, flu, headaches, sore throats, and toothaches.

This liquid formulation makes it easy for children to take, and it comes with a dosing cup for accurate measurement. If your child is experiencing discomfort from fever or minor pain, FeverAll may be a suitable option to help them feel better.

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 using this product, make sure to shake it well. To find the right dose, refer to the dosing chart based on your child's 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 dosage. For children weighing between 24 and 35 pounds (ages 2-3 years), the dose is 5 mL. If your child weighs 36-47 pounds (ages 4-5 years), the dose increases to 7.5 mL. For those weighing 48-59 pounds (ages 6-8 years), the dose is 10 mL, and for children weighing 60-71 pounds (ages 9-10 years), the dose is 12.5 mL. Finally, if your child weighs between 72-95 pounds (age 11 years), the dose is 15 mL.

You can repeat the dose every 4 hours as long as symptoms persist, but do not exceed 5 doses in a 24-hour period. It's important not to give this medication for more than 5 days unless directed by a doctor. Always use the enclosed dosing cup that comes with the product, as other devices may not provide the correct measurement. Remember, do not give more than the recommended amount to avoid any risk of overdose.

What to Avoid

It's important to be cautious when using this medication. You should not take it alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, if your child has a known allergy to acetaminophen or any of the inactive ingredients in this product, do not use it.

While using this medication, make sure to follow the recommended dosage carefully. Exceeding the recommended dose can lead to serious health risks, so always adhere to the guidelines provided. If you have any questions or concerns, don't hesitate to reach out to a healthcare professional for guidance.

Side Effects

You should be aware that 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, there is a risk of serious skin reactions, such as reddening, blisters, or rash. If any of these symptoms occur, stop using the product and seek medical help immediately.

It's important to avoid using this medication with any other acetaminophen-containing drugs and to consult a doctor 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 persists for more than 3 days, you should stop use and consult a doctor. In case of an overdose, which can also cause liver damage, seek medical assistance 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 containing acetaminophen. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any skin reactions, 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 right away.

Before using this product, check with a doctor if your child has liver disease or is taking the blood thinner warfarin. Always follow the recommended dosage to avoid overdose. In case of an overdose, seek medical help or contact a Poison Control Center at 1-800-222-1222 immediately, even if there are no noticeable symptoms. Additionally, 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 may indicate a serious condition.

Overdose

Taking more than the recommended dose of this medication can lead to serious liver damage. 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, quick medical attention is crucial for both adults and children. Remember, acting fast can make a significant difference in ensuring safety and health.

Pregnancy Use

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

As always, it's 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 or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, exercising caution is advised. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

When giving medication to your child, it's important to follow the recommended guidelines closely. Always use the dosing chart to find the right amount based on your child's weight or age. For example, children under 2 years old should not be given this medication without consulting a doctor. If your child is between 2 and 10 years old, the dose varies from 5 mL to 12.5 mL depending on their weight. Remember, you should not give more than 5 doses in a 24-hour period or use it for more than 5 days unless directed by a doctor.

Additionally, keep the medication out of reach of children to prevent accidental ingestion. If your child has liver disease or is taking the blood thinner warfarin, be sure to consult a doctor or pharmacist before administering the medication. Always adhere to the dosing instructions to avoid any risk of overdose.

Geriatric Use

It's important to be cautious when considering this product for older adults. If you or someone you care for has liver disease, it's essential to consult a doctor before using it. Additionally, if you are taking the blood-thinning medication warfarin, make sure to speak with a doctor or pharmacist beforehand, as there could be interactions.

In the event of an overdose, seek medical help immediately or contact a Poison Control Center. Quick action is crucial for everyone, including older adults, even if there are no immediate signs or symptoms of overdose. Always prioritize safety and communication with healthcare providers when using any medication.

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 may affect you 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 determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If your child has liver problems, it's important to be cautious with medications that contain acetaminophen. You should consult a doctor before using this product, as taking more than the recommended dose can lead to serious liver damage. Specifically, ensure that your child does not exceed five doses in a 24-hour period, which is the maximum daily limit, and avoid giving them other medications that also contain acetaminophen.

In the event of an overdose—taking more than the recommended amount—seek medical help immediately or contact a Poison Control Center. Quick action is essential, even if there are no immediate signs or symptoms of liver damage. Always prioritize safety and follow your healthcare provider's guidance.

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 best performance of your product, store it in a cool, dry place at a temperature between 20 to 25°C (68 to 77°F). It's important not to refrigerate the product, as this can affect its effectiveness.

Make sure to keep the original carton, as it contains important directions for use that you will need. Handling the product with care will help maintain its quality and safety.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as symptoms persist. However, do not exceed 5 doses in a 24-hour period, and avoid using it for more than 5 days unless your doctor advises otherwise.

It's important to keep this medication out of reach of children. If an overdose occurs, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial for both adults and children, even if there are no noticeable signs or symptoms.

FAQ

What is FeverAll?

FeverAll is an oral suspension liquid medication with a cherry flavor, intended for children ages 2-11 years.

What is the active ingredient in FeverAll?

The active ingredient in FeverAll is acetaminophen, which acts as a pain reliever and fever reducer.

What conditions does FeverAll treat?

FeverAll reduces fever and relieves minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

How should I dose FeverAll?

Use the enclosed dosing cup to measure the dose based on your child's weight or age, and do not exceed the recommended dose.

What are the dosing guidelines for FeverAll?

For children weighing 24-35 lbs (2-3 years), the dose is 5 mL; for 36-47 lbs (4-5 years), it's 7.5 mL; and so on, up to 15 mL for children weighing 72-95 lbs (11 years).

What should I do if I suspect an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately, as quick medical attention is critical.

Are there any warnings associated with FeverAll?

Yes, do not exceed 5 doses in 24 hours, and avoid using it with other drugs containing acetaminophen to prevent severe liver damage.

Can FeverAll be used during pregnancy?

The product insert does not provide specific information regarding the use of FeverAll during pregnancy.

Is it safe to use FeverAll while breastfeeding?

Nursing mothers should consult a doctor before using FeverAll, as there is potential for acetaminophen to be excreted in breast milk.

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

Stop use and consult a doctor if pain worsens or lasts more than 5 days, or if fever worsens or lasts more than 3 days.

Packaging Info

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

Packaging configurations for Feverall.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

FeverAll® is an oral suspension formulated for children aged 2 to 11 years. Each 5 mL dose contains 160 mg of acetaminophen, serving as a pain reliever and fever reducer. The product is presented in a liquid form with a cherry flavor, enhancing palatability for pediatric use. FeverAll® is packaged in a 4 fluid ounce (118 mL) bottle, and a dosing cup is enclosed to facilitate accurate administration. The National Drug Code (NDC) for this product is 51672-5319-8.

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 use in pediatric patients 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 dosage chart below, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative.

Dosing should be repeated every 4 hours as needed while symptoms persist. However, it is critical not to exceed 5 doses within a 24-hour period. Continuous use beyond 5 days should only occur under the guidance of a physician.

The enclosed dosing cup, specifically designed for use with this product, must be utilized for accurate dosing. No other dosing devices should be employed.

Dosage Chart:

  • For patients weighing under 24 lbs or under 2 years of age, the dose is to be determined by consulting a doctor.

  • For patients weighing 24-35 lbs (2-3 years), the dose is 5 mL.

  • For patients weighing 36-47 lbs (4-5 years), the dose is 7.5 mL.

  • For patients weighing 48-59 lbs (6-8 years), the dose is 10 mL.

  • For patients weighing 60-71 lbs (9-10 years), the dose is 12.5 mL.

  • For patients weighing 72-95 lbs (11 years), the dose is 15 mL.

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 administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Additionally, exceeding the recommended dose is contraindicated, as it poses a significant risk of overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, liver damage may occur if a child takes more than 5 doses within a 24-hour period or if it is used concurrently with other medications containing acetaminophen.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

Consultation Prior to Use Healthcare professionals should advise parents to consult a doctor before administering this product if the child has a history of liver disease. Additionally, it is recommended to seek guidance from a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

Dosage Adherence It is crucial to adhere strictly to the recommended dosage to avoid the risk of overdose.

Emergency Medical Assistance In the event of an overdose, immediate medical attention is necessary. Parents should contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Monitoring Symptoms Parents should be vigilant and discontinue use while consulting a healthcare provider if any of the following occur: worsening pain that lasts more than 5 days, a fever that worsens or persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires medical evaluation.

Severe Sore Throat If a sore throat is severe, persists beyond 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a doctor promptly.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be advised that acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek immediate medical assistance.

Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription, and should consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

Prior to use, it is recommended that patients consult a healthcare provider if they have liver disease or are taking anticoagulant medications such as warfarin.

While using this product, patients must adhere to the recommended dosage to avoid the risk of overdose, which can lead to liver damage. Patients should be instructed to discontinue use and seek medical advice 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 underlying condition.

In cases of overdose, immediate medical attention is crucial. Patients should be informed to contact a Poison Control Center or seek medical help without delay, even if no signs or symptoms are 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 any other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose may arise from unintentional duplication of therapy. 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 Feverall (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Feverall.
Details

Pediatric Use

Pediatric patients should not exceed the recommended dosage as outlined in the overdose warning. Dosing should ideally be based on weight; however, age may be used if weight is not available. The following dosing guidelines apply:

  • For patients under 24 lbs (under 2 years), consultation with a doctor is advised.

  • For patients weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL.

  • For patients weighing 36-47 lbs (4-5 years), the recommended dose is 7.5 mL.

  • For patients weighing 48-59 lbs (6-8 years), the recommended dose is 10 mL.

  • For patients weighing 60-71 lbs (9-10 years), the recommended dose is 12.5 mL.

  • For patients weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

Doses may be repeated every 4 hours while symptoms persist, but should not exceed 5 doses in a 24-hour period. Treatment should not extend beyond 5 days unless directed by a healthcare professional.

It is crucial to keep this medication out of reach of children. Prior to administration, consultation with a doctor is recommended if the pediatric patient has liver disease or is concurrently taking the anticoagulant warfarin.

Geriatric Use

Elderly patients should be aware that this product does not contain specific directions or complete warnings for adult use. It is essential for geriatric patients to consult a healthcare provider before using this product, particularly if they have underlying health conditions such as liver disease.

Additionally, elderly patients who are taking anticoagulants, such as warfarin, should seek advice from a doctor or pharmacist prior to use, as interactions may pose significant risks.

In the event of an overdose, it is crucial for elderly patients to obtain medical assistance or contact a Poison Control Center immediately. Prompt medical attention is vital for adults, including geriatric patients, even if no signs or symptoms are initially apparent.

Pregnancy

FeverAll (acetaminophen suspension) has not been associated with specific warnings or precautions for use during pregnancy. The prescribing information does not indicate any contraindications for pregnant patients or outline any risks to the fetus associated with its use during this period. Additionally, there are no dosage modifications or special precautions recommended for individuals who are pregnant. Healthcare professionals should consider the overall clinical context when recommending this medication to pregnant patients.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of this product on a nursing infant are not well studied; therefore, caution is advised.

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 absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is critical to adhere to the maximum daily limit of 5 doses within a 24-hour period to prevent severe liver damage. Additionally, patients must avoid concurrent use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Before administering this product, it is advisable for caregivers to consult a healthcare professional if the patient has a history of liver disease. In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Overdosage

Overdosage may result in significant liver damage, particularly when the recommended dosage is exceeded. It is imperative that healthcare professionals remain vigilant regarding the potential consequences of overdose.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay; the national hotline can be reached at 1-800-222-1222. Prompt intervention is crucial, as rapid medical attention is essential for both adults and children, even in the absence of observable signs or symptoms of overdose.

Healthcare professionals should ensure that patients and caregivers are aware of the importance of seeking help immediately if an overdose is suspected, reinforcing the need for vigilance in monitoring for any potential adverse effects.

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 to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this medication if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the product. Healthcare providers should instruct patients to discontinue use and seek medical advice 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.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with exceeding this dosage, including the potential for overdose. Additionally, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Patients should also be advised to speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe use of this product.

Storage and Handling

The product is supplied in a carton that contains essential information for use. It should be stored at a temperature range of 20 to 25°C (68 to 77°F) and must not be refrigerated. It is important to retain the carton to access the full directions for use.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours while symptoms persist. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period and advise against use for more than 5 days unless directed by a healthcare professional.

Patients should be counseled to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Feverall, 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 Feverall, 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.