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Childrens 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 2024
Label revision date
April 17, 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 2024
Label revision date
April 17, 2024
Manufacturer
KROGER COMPANY
Registration number
M013
NDC root
41226-779
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

This medication is designed to help you feel better when you're experiencing discomfort from various common ailments. It effectively reduces fever and relieves minor aches and pains associated with conditions like the common cold, flu, headaches, sore throats, and toothaches.

By addressing these symptoms, this medication can provide you with some relief, allowing you to manage your discomfort more effectively. If you're feeling unwell, it may be a helpful option to consider.

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 common cold, flu, headaches, sore throats, and toothaches.

This means that if you're feeling under the weather or experiencing mild pain, this medication can provide some relief to help you feel better.

Dosage and Administration

Before you start using this medication, make sure to shake the bottle well. It's important to follow the dosage instructions carefully, so you should check the dosage chart to find the right amount for your child. If possible, use your child's weight to determine the dose; if you don't have that information, you can use their age instead.

To give the medication, remove the child protective cap and squeeze the correct dose into the enclosed dosing cup. You can repeat this dose every 4 hours as long as your child's symptoms persist, but remember not to give more than 5 doses in a 24-hour period. For children under 2 years old and weighing less than 24 pounds, it's best to consult a doctor for the appropriate dose. For other age and weight ranges, the chart provides specific amounts, so be sure to follow it closely. Always use the dosing cup that comes with the medication, as other devices may not provide accurate measurements.

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 with a doctor or pharmacist. Additionally, if your child has an allergy to acetaminophen or any of the inactive ingredients in this product, do not use it.

Always follow the recommended dosage and avoid exceeding it, as this can lead to serious health risks. If you have any questions or concerns about using this medication, don't hesitate to reach out to a healthcare professional for guidance.

Side Effects

You should be aware of some important warnings and potential side effects when using this product. It 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 skin reddening, blisters, or rash. If any of these symptoms 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. You should also stop use and contact a doctor if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms appear, or if there is redness or swelling, as these could indicate a serious condition. Always consult a doctor before use if your child has liver disease or is taking the blood-thinning medication warfarin.

Warnings and Precautions

It's important to be aware of some key warnings and precautions 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, which may include symptoms like skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product immediately and seek medical help.

If you or your child has a sore throat that is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it's important to consult a doctor right away. In case of an overdose, seek emergency medical assistance or contact a Poison Control Center at 1-800-222-1222, even if no symptoms are present, as prompt attention is crucial.

You should also stop using the product and call your doctor if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms develop, or if you notice any redness or swelling, as these could indicate a more serious condition.

Overdose

If your child takes more than 5 doses of this medication in a 24-hour period, it can lead to severe liver damage. It's also important to be cautious if your child is using this product alongside other medications that contain acetaminophen (a common pain reliever), as this combination can also result in serious liver harm.

If you suspect an overdose, look for signs such as unusual tiredness, nausea, vomiting, or yellowing of the skin or eyes. If you notice any of these symptoms or believe your child may have taken too much, seek immediate medical help. It's always better to be safe and get professional advice in these situations.

Pregnancy Use

When it comes to using acetaminophen during pregnancy, there is currently no specific information available about its safety, recommended dosages, 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 taking acetaminophen or any medication. They can help you weigh the potential benefits and risks based on your individual health needs. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

When giving medication to your child, it's important to follow the recommended dosages based on their weight and age. For children under 2 years who weigh less than 24 lbs, consult your doctor before use. For those aged 2-3 years and weighing 24-35 lbs, the dose is 5 mL; for 4-5 years and 36-47 lbs, it's 7.5 mL; for 6-8 years and 48-59 lbs, it's 10 mL; for 9-10 years and 60-71 lbs, it's 12.5 mL; and for 11 years and 72-95 lbs, it's 15 mL. Always use the enclosed dosing cup to measure the medication and do not exceed 5 doses in a 24-hour period.

Be aware of potential safety concerns. Taking more than 5 doses in one day can lead to severe liver damage. Additionally, watch for any signs of severe skin reactions, such as redness, blisters, or rash, and seek medical help immediately if they occur. 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. Always check with a healthcare professional if your child has liver disease or is taking the blood thinner warfarin before administering the medication.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have 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, which is the maximum daily amount recommended. Additionally, be aware that other medications may also contain acetaminophen, so always check labels to avoid exceeding this limit.

Monitoring your liver function is crucial, and you should consult your healthcare provider for personalized advice on medication use and any necessary adjustments based on your 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 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 in a cool, dry place at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a sterile environment to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as your symptoms persist. However, make sure not to exceed 5 doses within a 24-hour period to avoid potential risks. If you have any questions or concerns about your treatment, it's always a good idea to consult with your healthcare provider.

FAQ

What is the primary use of this medication?

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

How should I dose this medication for my child?

Use the dosing chart based on your child's weight or age. Do not exceed 5 doses in 24 hours and repeat every 4 hours while symptoms last.

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

If the 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 this medication?

Yes, this product contains acetaminophen, which can cause severe liver damage if more than 5 doses are taken in 24 hours or if used with other acetaminophen-containing drugs.

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

If your child experiences skin reddening, blisters, or rash, stop use and seek medical help right away.

Can I use this medication if my child is allergic to acetaminophen?

No, do not use this medication if your child is allergic to acetaminophen or any of the inactive ingredients.

What should I do in case of an overdose?

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

Is there a specific dosing device I should use?

Yes, use only the enclosed dosing cup specifically designed for this product. Do not use any other dosing device.

Packaging Info

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

Packaging configurations for Childrens Pain and Fever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified as apap-dyefree, formulated in a 4 oz package.

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

Patients should adhere strictly to the prescribed dosage. Prior to administration, the product must be shaken well. The appropriate dose can be determined using the dosage chart provided below; weight is the preferred method for dosing, but age may be used if weight is not available.

To administer the dose, remove the child protective cap and dispense the calculated dose into the enclosed dosing cup. The dose may be repeated every 4 hours as needed while symptoms persist. However, it is imperative not to exceed 5 doses within a 24-hour period.

Dosage Chart:

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

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

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

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

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

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

The dosing cup provided with the product must be used exclusively for this purpose; no other dosing devices should be utilized.

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. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

  • This product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

  • Exceeding the recommended dosage while using this product is contraindicated due to the risk of overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the patient exceeds the maximum daily dosage of 5 doses within a 24-hour period or if it is taken concurrently with other medications containing acetaminophen. Healthcare professionals should monitor patients for signs of liver dysfunction, particularly in those who may be at higher risk.

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. Healthcare providers should educate patients on recognizing these symptoms and the importance of prompt action.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help, regardless of the presence of symptoms, as rapid intervention is essential for both adults and children.

Healthcare professionals should also advise patients to discontinue use and consult a physician if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. These signs may indicate a serious condition that necessitates further medical assessment.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur in patients who exceed the maximum daily dosage of acetaminophen, which is five doses within a 24-hour period, or who take this product in conjunction with other medications containing acetaminophen. It is crucial for patients to adhere to the recommended dosage to mitigate the risk of liver injury.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Patients are also advised to stop use and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or lasts more than three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients with liver disease consult a doctor before using this product. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist prior to use.

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 Childrens Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Pain and Fever.
Details

Pediatric Use

Pediatric patients under 24 lbs should consult a doctor before use. For those weighing 24-35 lbs (ages 2-3 years), the recommended dose is 5 mL; for 36-47 lbs (ages 4-5 years), 7.5 mL; for 48-59 lbs (ages 6-8 years), 10 mL; for 60-71 lbs (ages 9-10 years), 12.5 mL; and for 72-95 lbs (age 11 years), 15 mL. Dosing should primarily be based on weight; if weight is not available, age may be used as a guide. Doses may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period. Only the enclosed dosing cup designed for this product should be used for administration.

Severe liver damage may occur if the maximum daily amount of 5 doses is exceeded. Pediatric patients may also experience severe skin reactions to acetaminophen, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, use should be discontinued immediately, and medical assistance should be sought. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

It is advised to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

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

There are no specific statements regarding the use of this medication in nursing mothers or lactation. Therefore, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants and the excretion of the drug in breast milk are not established. It is advisable to consider the potential risks and benefits before making treatment decisions for lactating patients.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period. Exceeding this limit, particularly in patients with compromised liver function, may significantly increase the risk of hepatotoxicity.

Additionally, patients should be advised to avoid concomitant use of other medications containing acetaminophen to prevent cumulative dosing, which could further exacerbate the risk of liver injury. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy while using this product.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage, particularly in pediatric patients.

Risk of Liver Damage Administration of more than five doses within a 24-hour period exceeds the maximum recommended daily amount and significantly increases the risk of severe liver damage. Healthcare professionals should be vigilant in monitoring patients who may have ingested doses above this threshold.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk for liver injury. It is essential to assess the patient's medication history to identify any potential interactions that could exacerbate the risk of hepatotoxicity.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should initiate appropriate management procedures, which may include supportive care and monitoring of liver function tests. Early intervention is crucial to mitigate the risk of long-term hepatic complications.

Prompt recognition and management of acetaminophen overdosage can significantly improve patient outcomes.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients to avoid using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Patients should also be advised to discontinue use and consult a doctor if pain worsens or persists for more than 5 days, if fever worsens or lasts longer than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

While using this medication, patients must not exceed the recommended dose, as indicated in the overdose warning. Additionally, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease or is taking the anticoagulant medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for 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. Proper storage conditions must be adhered to, ensuring that the product is kept within this temperature range at all times.

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. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Childrens 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 Childrens 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.

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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.