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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 10, 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 10, 2024
Manufacturer
WALGREENS
Registration number
M013
NDC root
0363-7014
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

You may be looking for a medication that helps reduce fever and relieve minor aches and pains. This type of medication is commonly used for discomfort associated with the common cold, flu, headaches, sore throats, and toothaches. It is designed for temporary relief, making it a helpful option when you're feeling unwell.

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 make you feel more comfortable when you're dealing with these everyday ailments. If you're experiencing any of these symptoms, it may be a helpful option for you.

Dosage and Administration

Before you start using this medication, make sure to shake the bottle well. To find the right dose for your child, refer to the dosage chart based on their 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 guidance. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 5 mL. As the weight increases, so does the dose, reaching up to 15 mL for children who are 11 years old and weigh between 72 and 95 pounds.

When you’re ready to give the medication, remove the child protective cap and carefully squeeze the correct dose into the enclosed dosing cup, which is specifically designed for this product. You can repeat this dose every 4 hours as long as your child continues to have symptoms, but remember not to exceed 5 doses in a 24-hour period. Always follow these instructions closely to ensure your child receives the right amount safely.

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, do not use this product if your child is allergic to acetaminophen or any of its inactive ingredients.

While using this medication, make sure to follow the recommended dosage and avoid exceeding it, as doing so can lead to serious health risks. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

It's important to consult a doctor if your child's sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, you should 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 check with a doctor before use if your child has liver disease or is taking the blood thinner 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 and seek medical help immediately.

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. These could indicate a more serious condition that needs medical evaluation.

Overdose

Taking too much of this product, which contains acetaminophen, can lead to serious health issues, particularly severe liver damage. If your child takes more than 5 doses in a 24-hour period, this is considered an overdose. Additionally, combining this product with other medications that also contain acetaminophen can increase the risk of liver damage.

If you suspect an overdose, look for signs such as nausea, vomiting, loss of appetite, confusion, or unusual tiredness. It’s crucial to seek immediate medical help if you notice any of these symptoms or if you believe your child has taken too much. Always remember to keep track of all medications your child is taking to avoid accidental overdoses.

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 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

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to be cautious when giving medication to children. You should not use this medication in children under 2 years of age without first consulting a doctor. For children aged 2 to 11 years, the recommended doses vary by weight: for those weighing 24-35 lbs (2-3 years), give 5 mL; for 36-47 lbs (4-5 years), give 7.5 mL; for 48-59 lbs (6-8 years), give 10 mL; for 60-71 lbs (9-10 years), give 12.5 mL; and for 72-95 lbs (11 years), give 15 mL. Remember, the maximum dosage is 5 doses in a 24-hour period to avoid severe liver damage.

Before giving this medication, 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, stop use and seek medical advice. Additionally, if new symptoms arise or if there is any redness or swelling, contact a doctor. In case of an overdose, it's crucial to seek medical help immediately, even if there are no noticeable symptoms.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available regarding its safety or effectiveness. This means that if you or a loved one is an older adult, it's especially important to consult with a healthcare provider before starting this medication. They can help assess any unique health needs or concerns you may have, ensuring that the treatment is appropriate for you. Always prioritize open communication with your healthcare team to make informed decisions about your health.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

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 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 and safety 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 of the device and its components.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Proper storage and careful handling are essential for ensuring the product works effectively and safely.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as symptoms persist, but do not exceed 5 doses in a 24-hour period. It's important to consult a doctor before use if your child has liver disease or is taking the blood-thinning medication warfarin.

If your child's pain worsens or lasts more than 5 days, if a fever worsens or lasts more than 3 days, if new symptoms develop, or if there is any redness or swelling, stop using the medication and contact a doctor.

FAQ

What is this drug used for?

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

How should I administer this drug to my child?

Use the enclosed dosing cup specifically designed for this product. Shake well before using and follow the dosing chart based on your child's weight or age.

What is the maximum dosage for children?

Do not exceed 5 doses in 24 hours. Repeat doses can be given every 4 hours while symptoms last.

Are there any warnings I should be aware of?

Yes, severe liver damage may occur if your child takes more than 5 doses in 24 hours or with other drugs containing acetaminophen. Additionally, watch for severe skin reactions and consult a doctor if symptoms persist.

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

No, do not use this drug 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 this drug safe for use during pregnancy or while nursing?

The insert does not provide specific information regarding the use of this drug during pregnancy or nursing.

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

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

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

No specific details regarding the Description section for SPL code 34089-3 are provided in the text.

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 recommended 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 prescribed amount into the enclosed dosing cup, which is specifically designed for use with this product. The dose may be repeated every 4 hours as needed while symptoms persist, but it is imperative not to exceed 5 doses within a 24-hour period.

Dosage Chart:

  • Under 24 lbs / Under 2 years: Consult a doctor

  • 24-35 lbs / 2-3 years: 5 mL

  • 36-47 lbs / 4-5 years: 7.5 mL

  • 48-59 lbs / 6-8 years: 10 mL

  • 60-71 lbs / 9-10 years: 12.5 mL

  • 72-95 lbs / 11 years: 15 mL

Dosing should be as directed by a healthcare professional when necessary.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

  • In patients with a known allergy to acetaminophen or any of the inactive ingredients in this formulation, as this may lead to severe allergic reactions.

  • Exceeding the recommended dosage is contraindicated, as it may result in overdose and associated complications.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that exceeding five doses within a 24-hour period, which is the maximum daily amount, or concomitant use with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and 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, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider without delay.

Emergency medical help should be sought in the event of an overdose. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to stop taking the medication and consult a healthcare professional if any of the following occur: worsening pain lasting more than five days, fever that worsens or persists beyond three days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use it concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, 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.

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

Additional precautions include stopping use and consulting 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.

Patients with a history of liver disease should seek medical advice before using this product. Furthermore, it is recommended that patients taking the blood-thinning medication warfarin consult a doctor 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. The risk of acetaminophen overdose and associated hepatotoxicity may be heightened. 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 2 years of age should not use this medication without consulting a doctor. For children aged 2 to 11 years, the recommended dosing is as follows: 5 mL for those weighing 24-35 lbs (2-3 years), 7.5 mL for those weighing 36-47 lbs (4-5 years), 10 mL for those weighing 48-59 lbs (6-8 years), 12.5 mL for those weighing 60-71 lbs (9-10 years), and 15 mL for those weighing 72-95 lbs (11 years).

The maximum dosage should not exceed 5 doses in a 24-hour period, as severe liver damage may occur with higher intake. Parents and caregivers should consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin.

Healthcare professionals should advise parents to stop use and seek medical advice if the child's pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, even if no signs or symptoms are apparent.

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, particularly those aged 65 and older.

Due to the lack of clinical data in this population, it is advisable to closely monitor geriatric patients for any adverse effects or changes in efficacy. Additionally, consideration should be given to potential age-related physiological changes that may affect drug metabolism and clearance.

Healthcare providers are encouraged to evaluate the individual needs and health status of elderly patients when determining the appropriate dosage and treatment regimen.

Pregnancy

The safety of acetaminophen use during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for its use during pregnancy. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen to weigh the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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, or concomitant use with other medications containing acetaminophen, may significantly increase the risk of liver injury.

Healthcare providers should evaluate liver function prior to initiating treatment and consider the potential for dose adjustments based on the severity of hepatic impairment. Regular monitoring of liver enzymes may be warranted to ensure patient safety and to mitigate the risk of adverse effects related to liver function.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with the use of this product, which contains acetaminophen.

Risk of Liver Damage Healthcare professionals should be aware that if a child ingests more than 5 doses of this product within a 24-hour period, which is the maximum recommended daily amount, there is a significant risk of severe liver damage. Additionally, the concomitant use of this product with other medications containing acetaminophen can further exacerbate the risk of liver injury.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should assess the patient's clinical status and consider the need for laboratory tests to evaluate liver function. Prompt intervention is essential to mitigate the potential for serious hepatic complications.

Management Procedures Management of acetaminophen overdosage may include the administration of N-acetylcysteine (NAC) as an antidote, particularly if the overdose is identified within a critical time frame. Continuous monitoring of liver function tests and supportive care should be provided as necessary.

It is imperative for healthcare professionals to educate caregivers about the importance of adhering to dosing guidelines and to be vigilant regarding the use of multiple acetaminophen-containing products to prevent overdosage.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

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 caution patients against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Patients should be instructed to discontinue use and consult a doctor if pain worsens or persists for more than 5 days, if fever intensifies 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 product, patients must not exceed the recommended dosage, as highlighted in the overdose warning. Additionally, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in 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 needed, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin.

Patients should be instructed to discontinue use and seek medical advice 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.

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.