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Feverall

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This product has been discontinued

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
June 14, 2023
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
June 14, 2023
Manufacturer
TARO PHARMACEUTICALS U. S. A. , INC.
Registration number
part343
NDC root
51672-5320
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

FeverAll is a liquid oral suspension designed for children ages 2 to 11 years. It contains acetaminophen (160 mg per 5 mL), which is a common pain reliever and fever reducer. This medication is effective in reducing fever and alleviating minor aches and pains associated with conditions like the common cold, flu, headaches, sore throats, and toothaches. FeverAll comes in a pleasant grape flavor and includes a dosing cup for easy measurement.

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 unwell, making it easier to manage everyday discomforts.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. To ensure safety, always follow the recommended dosage and never exceed the amount directed, as doing so can lead to an overdose.

Start by shaking the bottle well before each use. To find the right dose, refer to the dosing chart based on your child's weight or age. If your child weighs under 24 pounds or is under 2 years old, consult a doctor for the appropriate dose. For children weighing between 24-35 pounds (ages 2-3 years), the dose is 5 mL. If your child weighs 36-47 pounds (ages 4-5 years), give 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), it's 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 give more than 5 doses in a 24-hour period. Additionally, do not use this product 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.

What to Avoid

It's important to be cautious when using this medication. You should not use 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 not exceed the recommended dose. Taking more than the advised amount can lead to serious health risks, so always follow the dosage instructions carefully. If you have any questions or concerns, don't hesitate to reach out to a healthcare professional for guidance.

Side Effects

Taking acetaminophen can lead to some serious side effects, so it's important to be aware of them. Severe liver damage may occur if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Additionally, be cautious of potential severe skin reactions, which can include symptoms like skin reddening, blisters, or rash. If any of these occur, 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. Always avoid using this medication with any other acetaminophen-containing products, and check with a healthcare professional if your child has liver disease or is taking blood thinners like warfarin. If pain or fever worsens or lasts longer than the recommended time, or if new symptoms arise, stop use and contact a doctor, as these could indicate a more serious condition. In case of overdose, which can also lead to liver damage, seek medical help immediately.

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 redness, blisters, or rashes. 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. If you suspect an overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222, as quick attention is crucial for both adults and children.

You should 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. These could indicate a more serious condition that needs medical attention.

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

When considering the use of FeverAll (acetaminophen suspension) during pregnancy, it's important to note that the information available does not specify any particular guidelines or risks associated with its use. There are no explicit warnings about potential harm to the fetus, and no dosage adjustments for pregnant individuals are mentioned.

While the insert does not outline any special precautions for pregnant individuals, it's always 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, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, which means it could affect your nursing infant. Since the effects of acetaminophen on babies who are breastfed haven't been thoroughly studied, it's best to be cautious and seek professional advice.

Pediatric Use

It's important to be cautious when giving medication to children. You should not give this medication to children under 2 years old without first consulting a doctor. For children aged 2 to 11 years, the recommended dosage varies based on their weight and age. For example, a child weighing 24-35 pounds (ages 2-3) should receive 5 mL, while a child weighing 72-95 pounds (age 11) can take 15 mL. Remember, the maximum amount you can give in a day is 5 doses, and it should not be used for more than 5 days unless a doctor advises otherwise.

Additionally, if your child has liver disease or is taking a medication called warfarin (which is used to prevent blood clots), you should consult a doctor before using this medication. Always keep it out of reach of children to ensure their safety.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person’s health needs can vary. Since the insert does not mention any age-related dosage adjustments, safety concerns, or special precautions for elderly patients, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is appropriate for your individual health situation and any other medications you may be taking.

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

Hepatic Impairment

If your child has liver disease, it’s important to consult a doctor before using this medication. Taking more than the recommended dose can lead to serious liver damage. Specifically, if your child takes more than 5 doses within a 24-hour period, which is the maximum allowed, there is a risk of severe liver damage. Additionally, be cautious about combining this medication with other products that contain acetaminophen, as this can also increase the risk of liver harm. Always follow dosing guidelines carefully to protect your child's liver health.

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 your healthcare provider informed about all medications your child is taking helps ensure their safety and well-being.

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.

When handling the product, always do so with clean hands and in a safe environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as your 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. Always follow these guidelines to ensure safe and effective use of the medication.

FAQ

What is FeverAll?

FeverAll is an oral suspension liquid that contains acetaminophen (160 mg/5 mL) and is used as a pain reliever and fever reducer for children ages 2-11 years.

What conditions does FeverAll help relieve?

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. Do not exceed 5 doses in 24 hours and do not use for more than 5 days unless directed by a doctor.

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 FeverAll?

Yes, do not use FeverAll with any other drug containing acetaminophen, and be cautious if your child has liver disease or is taking warfarin. Severe liver damage may occur with overdose.

What should I do in case of an overdose?

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

Can FeverAll be used during pregnancy?

The insert does not provide specific information regarding the use of FeverAll during pregnancy, so consult a doctor before use.

Is it safe to use FeverAll while breastfeeding?

Nursing mothers should consult a doctor before using FeverAll, as acetaminophen may be excreted in breast milk and its effects on a nursing infant are not well studied.

What are the side effects of FeverAll?

Possible side effects include severe skin reactions such as skin reddening, blisters, or rash. If any of these occur, stop use and seek medical help immediately.

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 liquid 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 grape flavor and is packaged in a 4 fluid ounce (118 mL) bottle. An NDC of 51672-5320-8 is assigned to this formulation, and a dosing cup is enclosed for accurate administration.

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 specific dosing instructions must be followed to ensure safety and efficacy. Prior to administration, the product should be shaken well.

Dosing should be determined using the chart provided below, with weight being the preferred method for dosing. If weight is not available, age may be used as a secondary reference. The recommended dosing intervals are every 4 hours as needed while symptoms persist, with a maximum of 5 doses in a 24-hour period. Treatment should not exceed 5 consecutive days unless directed by a healthcare professional.

The enclosed dosing cup, specifically designed for use with this product, must be utilized for accurate dosing. The use of any other dosing device is not recommended.

Dosage Chart:

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

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

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

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

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

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

Healthcare professionals should ensure that patients do not exceed the recommended doses and should monitor for any signs of overdose.

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 dosage is contraindicated, as it poses a 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, healthcare professionals should advise caregivers 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.

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

Consultation Recommendations Healthcare providers should recommend that caregivers consult a physician prior to administering this product if the child has a history of liver disease. Furthermore, it is advisable to seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin.

Dosage Adherence It is critical to adhere to the recommended dosage guidelines to avoid the risk of overdose. Caregivers should be informed of the overdose warning and the importance of not exceeding the prescribed amount.

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

Monitoring and Follow-Up Caregivers should be advised to discontinue use and consult a physician if any of the following occur: worsening pain that persists beyond 5 days, a fever that worsens or lasts 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.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of five doses within a 24-hour period or who take the product in conjunction with other medications containing acetaminophen. Patients should be aware that acetaminophen can lead to severe skin reactions, 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 two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. The product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients are advised to consult a doctor or pharmacist. Additionally, this product should not be administered to patients with a known allergy to acetaminophen or any of the inactive ingredients.

Before using this product, patients with liver disease should seek medical advice. Furthermore, patients taking the anticoagulant warfarin should consult a doctor or pharmacist prior to use. It is crucial for patients to adhere to the recommended dosage, as exceeding this may lead to overdose and potential liver damage.

Patients should discontinue use and consult a healthcare provider if pain worsens or persists beyond five days, if fever worsens or lasts more than three days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition. In cases of overdose, immediate medical attention is essential, and patients should contact a Poison Control Center without delay, even if no signs or symptoms are apparent. Quick medical intervention is critical for both adults and children.

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 under 2 years of age should not be administered this medication without prior consultation with a healthcare professional. Recommended dosing is based on weight and age, as follows: for children weighing 24-35 lbs (ages 2-3 years), the dose is 5 mL; for those weighing 36-47 lbs (ages 4-5 years), the dose is 7.5 mL; for children weighing 48-59 lbs (ages 6-8 years), the dose is 10 mL; for those weighing 60-71 lbs (ages 9-10 years), the dose is 12.5 mL; and for children weighing 72-95 lbs (age 11 years), the dose is 15 mL.

The maximum daily amount should not exceed 5 doses within a 24-hour period. This medication should not be used for more than 5 consecutive days unless directed by a healthcare provider. Additionally, it is important to consult a doctor if the pediatric patient has liver disease or is concurrently taking warfarin. Care should be taken to keep this medication out of reach of children.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age considerations, dosage adjustments, or safety concerns pertinent to this population. Consequently, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, as individual responses may vary. Monitoring for efficacy and safety is advised, given the absence of tailored recommendations for elderly patients.

Pregnancy

The available prescribing information for FeverAll (acetaminophen suspension) does not provide specific data regarding its use during pregnancy. There are no explicit statements concerning contraindications or risks to the fetus associated with the use of this medication in pregnant patients. Additionally, the prescribing information does not indicate any required dosage modifications for individuals who are pregnant. Furthermore, there are no special precautions outlined for the use of this product during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed 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 consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is critical to adhere to the recommended dosage, as exceeding this may lead to liver damage. Specifically, severe liver damage can occur if a patient takes more than five doses within a 24-hour period, which is the maximum daily limit. Additionally, caution is advised when considering the use of acetaminophen in conjunction with other medications that also contain acetaminophen, as this combination may further increase the risk of severe liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dosage is exceeded. It is imperative that healthcare professionals recognize the seriousness of this situation and act promptly.

Immediate medical assistance is crucial. In cases of suspected overdose, individuals should seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222. This step is essential for both adults and children, as timely intervention can mitigate the risk of severe complications, even in the absence of noticeable symptoms.

Healthcare providers should remain vigilant and ensure that patients and caregivers are aware of the importance of seeking help immediately, reinforcing that quick medical attention is vital regardless of the presence of overt signs or symptoms of overdose.

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 that this product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. 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 or is currently taking the blood-thinning medication warfarin.

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). Refrigeration is not recommended, as the product must not be stored in cold conditions. It is advised 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 as long as symptoms persist. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period and should not administer the medication for more than 5 consecutive days unless directed by a healthcare professional.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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.