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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 2020
Label revision date
May 28, 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 2020
Label revision date
May 28, 2024
Manufacturer
Strategic Sourcing Services LLC
Registration number
M013
NDC root
62011-0461
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 pain and reduce fever. It comes in an oral suspension form, specifically designed for children aged 2 to 11 years, and is available in a pleasant cherry flavor. This medication temporarily alleviates minor aches and pains associated with conditions such as the common cold, flu, headaches, sore throats, and toothaches.

As a pain reliever and fever reducer, acetaminophen works by affecting the body's pain and temperature regulation systems. It is important to note that this product is alcohol-free, aspirin-free, and ibuprofen-free, making it a suitable option for many children.

Uses

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

This means that if you're feeling under the weather or dealing with everyday pains, this medication can help you feel more comfortable for a short period. Always remember to follow the recommended guidelines for use.

Dosage and Administration

Before using this product, make sure to shake it well. It's important to use the dosing cup that comes with the product, as other measuring devices may not provide the correct amount. When determining the right dose, refer to the dosage chart based on your child's weight and age. If your child weighs less than 24 pounds and is under 2 years old, consult a doctor for the appropriate dose. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the dose is 5 mL.

You can repeat the dose every 4 hours as needed while symptoms persist, but do not exceed 5 doses in a 24-hour period. Additionally, do not use this product for more than 5 days unless directed by a doctor. Always follow the guidelines carefully to ensure safe and effective use.

What to Avoid

You should avoid using this medication if you are taking any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. If you're unsure about a medication's ingredients, it's best to consult with your doctor or pharmacist. Additionally, do not use this product if your child is allergic to acetaminophen or any of its inactive 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 be mindful of these guidelines to ensure safe use of the medication.

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, including redness, blisters, and 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. It's important to avoid using this product with any other acetaminophen-containing medications and to seek medical advice if your child has liver disease or is taking blood thinners like warfarin. Always monitor for new symptoms, worsening pain, or prolonged fever, as these could indicate a serious condition. In case of overdose, which can cause 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 skin reddening, blisters, or rash. If you notice any skin reactions, 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 product, 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 right away, even if there are no immediate symptoms. You should also stop using the product and call your doctor if new symptoms appear, if there is redness or swelling, if pain worsens or lasts more than 5 days, or if fever worsens or lasts more than 3 days, as these could 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, even if you don’t notice any symptoms. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Remember, quick action is crucial in these situations. Always prioritize your health and safety by getting help right away if you think you’ve taken too much.

Pregnancy Use

When it comes to using acetaminophen during pregnancy, there is currently no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it's important to consult with your healthcare provider before using acetaminophen. They can help you weigh the potential benefits and risks based on your individual situation. Always prioritize open communication with your doctor regarding any medications you consider taking during this important time.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that acetaminophen (a common pain reliever) can pass into your breast milk. Because the effects on your nursing infant are not completely understood, you should exercise caution when considering this medication. Always prioritize your health and your baby's well-being by seeking professional advice.

Pediatric Use

If your child is between the ages of 2 and 11 years, it's important to follow specific dosing guidelines. For children under 24 pounds, or under 2 years old, you should consult a doctor before giving any medication. For those aged 2 to 3 years and weighing between 24-35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4-5 years (36-47 pounds), 10 mL for ages 6-8 years (48-59 pounds), 12.5 mL for ages 9-10 years (60-71 pounds), and 15 mL for 11-year-olds (72-95 pounds).

It's crucial not to exceed 5 doses in a 24-hour period or to use the medication for more than 5 days unless directed by a doctor. Additionally, if your child has liver disease or is taking the blood-thinning medication warfarin, you should consult a doctor or pharmacist before use. Always prioritize your child's safety by following these guidelines closely.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available in the drug insert. This means that healthcare providers may not have detailed guidelines tailored for elderly patients. If you or a loved one is an older adult considering this medication, it’s important to discuss any concerns with your doctor. They can help determine the best approach based on individual health needs and any other medications being taken.

Always remember that older adults may have different responses to medications, so close monitoring for any side effects or changes in health is essential. Your healthcare provider can guide you on the appropriate dosage and any necessary precautions to ensure safety and effectiveness.

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 monitor your kidney function and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If your child has liver problems, it's important to be cautious with medications that contain acetaminophen. Taking more than 5 doses in a 24-hour period can lead to severe liver damage, as can combining it with other medications that also contain acetaminophen. Always consult a doctor before using this product if your child has liver disease.

In case of an overdose—taking more than the recommended amount—liver damage may occur. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick action is essential, even if there are no immediate signs or symptoms.

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, you should avoid using this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, don't hesitate to ask 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 at room temperature, specifically between 20-25ºC (68-77ºF). It's important to avoid refrigeration, as this can affect the product's effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided with the product to ensure safe and effective use.

Additional Information

You should take this medication orally. If you need to, you can repeat the dose every 4 hours while your symptoms last, but make sure not to exceed 5 doses in a 24-hour period. Additionally, do not use this medication for more than 5 days unless your doctor advises you to do so.

FAQ

What is Acetaminophen used for?

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

What is the recommended dosage for children?

The dosage varies by weight and age. For example, children weighing 24-35 lb (ages 2-3 years) should take 5 mL, while those weighing 72-95 lb (age 11 years) should take 15 mL.

Are there any warnings associated with Acetaminophen?

Yes, you should not exceed 5 doses in 24 hours, and it may cause severe liver damage if taken with other acetaminophen-containing drugs or in excessive amounts.

Can Acetaminophen be used during pregnancy?

The insert does not provide specific information regarding the use of acetaminophen during pregnancy, so consult your doctor for advice.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately, as quick medical attention is critical.

Is Acetaminophen safe for children?

Acetaminophen is safe for children ages 2-11 years when used as directed, but you should consult a doctor if your child has liver disease or is taking warfarin.

What flavor does Acetaminophen come in?

Acetaminophen is available in a cherry flavor.

How should I store Acetaminophen?

Store Acetaminophen between 20-25ºC (68-77ºF) and do not refrigerate.

Packaging Info

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

Packaging configurations for Pain and Fever.
Details

Drug Information (PDF)

This file contains official product information for 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 serves as a pain reliever and fever reducer, specifically designed for pediatric use in children aged 2 to 11 years. The formulation is free from alcohol, aspirin, and ibuprofen, ensuring a safer option for this age group. The product is presented in a cherry flavor to enhance palatability.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the temporary relief of minor aches and pains associated with conditions such as 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 healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight and age. It is essential to shake the product well before use. The enclosed dosing cup, specifically designed for this product, must be utilized; no other dosing devices should be employed.

The recommended dosing intervals are as follows: if necessary, the dose may be repeated every 4 hours while symptoms persist. However, it is crucial not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a physician.

Dosage Chart:

  • For patients weighing less than 24 lb and under 2 years of age, the dose should be determined by consulting a doctor.

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

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

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

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

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

Dosing may also be adjusted as directed by a healthcare professional. It is imperative to adhere to the maximum dosage limits and to consult a physician for any uncertainties regarding administration.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

This product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation.

Additionally, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dosage poses a risk of overdose.

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 be vigilant in monitoring for signs of liver injury in pediatric patients.

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.

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

Healthcare providers should inquire about any existing liver disease in pediatric patients prior to recommending this product. Additionally, it is essential to consult with a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Healthcare professionals should instruct caregivers to contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent.

Patients should be advised to discontinue use and consult a healthcare provider if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days. These symptoms 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 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 are advised to avoid using this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription.

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 skin reaction occurs, patients should discontinue use immediately and seek medical assistance.

In cases where sore throat is severe, 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 with a history of liver disease should consult a doctor before using this product. Additionally, those taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

While using this product, it is crucial not to exceed the recommended dosage. Patients should stop use and consult a doctor if new symptoms arise, if redness or swelling is observed, if pain worsens or lasts more than 5 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious condition.

An overdose warning is also present; taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is imperative to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, 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 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 Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain and Fever.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication with specific dosing guidelines based on weight and age. For children weighing under 24 lb (under 2 years), consultation with a healthcare provider is advised prior to administration.

The recommended dosages for children aged 2 to 11 years are as follows:

  • 24-35 lb (2-3 years): 5 mL

  • 36-47 lb (4-5 years): 7.5 mL

  • 48-59 lb (6-8 years): 10 mL

  • 60-71 lb (9-10 years): 12.5 mL

  • 72-95 lb (11 years): 15 mL

It is important to note that no more than 5 doses should be administered within a 24-hour period, and treatment should not exceed 5 days unless directed by a healthcare professional.

Healthcare providers should inquire about any existing liver disease in pediatric patients before prescribing this medication. Additionally, consultation with a doctor or pharmacist is recommended if the child is concurrently taking the anticoagulant warfarin.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, given the physiological changes associated with aging that may affect drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and polypharmacy, which are common in geriatric patients and may necessitate dosage adjustments or increased monitoring.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients. There are no established safety concerns, dosage modifications, or special precautions outlined for its use in this population. Given the lack of detailed information, healthcare providers are encouraged to weigh the potential benefits against any unknown risks when considering acetaminophen for women of childbearing potential. Further research may be necessary to fully understand the implications of acetaminophen use during pregnancy.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this product to nursing mothers, as the effects on the nursing infant are not fully understood.

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.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the maximum daily amount of more than 5 doses in 24 hours is exceeded or if the product is taken concurrently with other medications containing acetaminophen.

Prior to use, it is recommended that a healthcare professional be consulted if the patient has a history of liver disease. In the event of an overdose, which may result from taking more than the recommended dose, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical attention is critical, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose of this medication may lead to liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Prompt medical attention is crucial, even if the individual does not exhibit any signs or symptoms of overdose. Healthcare professionals should be aware that early intervention can significantly impact the outcome in cases of suspected 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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as 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 containing acetaminophen, whether prescription or non-prescription. 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 to avoid using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Additionally, patients should be advised to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or persists for more than five days, or if fever intensifies or lasts longer than three days, as these may indicate a serious condition.

Healthcare providers should remind patients to adhere strictly to the recommended dosage to prevent overdose. Furthermore, patients should be encouraged to consult a doctor before using this product if their child has liver disease or is currently taking the blood-thinning medication warfarin, as these factors may influence the safety and efficacy of the treatment.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as the product should not be exposed to temperatures outside this specified range. Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with the option to repeat the dose every 4 hours as needed while symptoms persist. Clinicians should advise patients not to exceed 5 doses within a 24-hour period and to limit use to a maximum of 5 days unless otherwise directed by a healthcare professional.

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

Drug Information (PDF)

This file contains official product information for 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 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

Last AI update:

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.