Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Childrens Pain and Fever

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
July 24, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Solution
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 2022
Label revision date
July 24, 2023
Manufacturer
CalmCo LLC
Registration number
part343
NDC root
73282-2016
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 temporarily reduces fever and relieves minor aches and pains. This type of medication is commonly used for discomfort associated with the common cold, flu, headaches, sore throats, and toothaches.

By working to lower your body temperature and alleviate pain, it can help you feel more comfortable when you're not feeling well. If you're experiencing any of these symptoms, this medication might be a helpful option for you.

Uses

You can use this medication to temporarily 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 help you feel better when you're experiencing these common ailments, providing relief so you can go about your day more comfortably.

Dosage and Administration

If your child weighs under 24 pounds and is under 2 years old, it's important to talk to a doctor before giving them this medication. For children who weigh between 24 and 35 pounds, typically aged 2 to 3 years, you should use 1 Single-Use Vial, which contains 5 mL of the medication.

For children weighing between 36 and 47 pounds, usually aged 4 to 5 years, you should also consult a doctor for guidance. If your child weighs between 48 and 71 pounds, generally aged 6 to 10 years, the recommended dosage is 2 Single-Use Vials, totaling 10 mL. Finally, for children who weigh between 72 and 95 pounds, around 11 years old, the dosage increases to 3 Single-Use Vials, which is 15 mL. Always ensure you follow these guidelines closely for the safety and health of your child.

What to Avoid

It's important to be cautious when using this medication. You should not take it alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication includes acetaminophen, please consult your doctor or pharmacist for clarification.

Additionally, do not use this product if your child has a known allergy to acetaminophen or any of the inactive ingredients listed in the product. Always prioritize safety and seek professional advice if you have any questions or concerns.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. If your child takes more than 5 doses in 24 hours, or if they use it alongside other medications containing acetaminophen, there is a risk of severe liver damage. Additionally, acetaminophen can cause severe skin reactions, which may include symptoms like skin reddening, blisters, or rash. If any of these occur, stop using the medication and seek medical help immediately.

You should also consult a doctor if 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 crucial to stop using the medication and contact a healthcare professional if pain worsens or lasts more than 5 days, if fever persists for more than 3 days, or if new symptoms arise. Always avoid using this medication with any other acetaminophen products and ensure your child is not allergic to acetaminophen or any inactive ingredients. In case of an overdose, seek medical help or contact a Poison Control Center right away, even if no symptoms are present.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses other medications that also contain acetaminophen. It's important to be aware of potential allergic reactions; severe skin reactions such as reddening, blisters, or rash can occur. If you notice any of these symptoms, 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, talk to a doctor if your child has liver disease or is taking the blood-thinning medication warfarin. 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. In case of overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, even if no symptoms are present.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Getting prompt medical attention is crucial, even if you don’t notice any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you or someone you know is experiencing these symptoms, don’t hesitate to reach out for help right away. Your safety is the top priority.

Pregnancy Use

When considering the use of DrKids Children's Pain and Fever (acetaminophen 160mg/5ml solution) during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this medication on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before taking any medication, including over-the-counter options like acetaminophen. They can provide personalized advice based on your health needs and the latest medical guidelines.

Lactation Use

If you are breastfeeding or planning to breastfeed, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider about any concerns you may have regarding your health and breastfeeding.

Pediatric Use

When considering this medication for your child, it's important to follow specific dosing guidelines based on their weight and age. For children under 24 pounds or under 2 years old, you should consult a doctor before use. For those weighing between 24 to 35 pounds (ages 2 to 3), the recommended dose is one single-use vial (5 mL). If your child weighs between 36 to 47 pounds (ages 4 to 5), again, consult a doctor. For children weighing 48 to 71 pounds (ages 6 to 10), the dose is two single-use vials (10 mL), and for those who are 11 years old and weigh 72 to 95 pounds, the dose is three single-use vials (15 mL).

Always check with a doctor if your child has liver disease or is taking the blood thinner warfarin. You should stop using the medication and consult a doctor if your child's pain worsens or lasts more than 5 days, if a fever persists for more than 3 days, if new symptoms appear, or if there is any redness or swelling. Additionally, do not use this medication with any other products containing acetaminophen, and avoid it if your child is allergic to acetaminophen or any of the inactive ingredients.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since the insert mainly discusses pediatric use, you should consult your healthcare provider for personalized advice, especially if you or a loved one is an older adult. They can help determine if any dosage adjustments or special precautions are necessary based on individual health needs.

Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a healthcare professional is essential for ensuring safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations for patients with renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

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, which is the maximum daily amount for this product. Additionally, you should always consult a doctor before using this medication if your child has liver disease, as they can provide guidance tailored to your child's specific health needs.

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. Warfarin helps prevent blood clots, and combining it with other medications can affect how well it works or increase the risk of side effects.

Always keep your healthcare provider informed about all medications your child is taking to ensure their safety and well-being. This way, you can avoid any potential interactions and make informed decisions about their treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 68-77ºF (20-25ºC). This helps maintain its quality and performance.

When handling the product, be cautious: if the top flap of the carton is open or if any vials are open or broken, do not use the product. This tamper-evident feature is important for your safety, so always check the packaging before use.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

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

What should I do if my child weighs under 24 lbs?

If your child weighs under 24 lbs (under 2 years), you should talk to a doctor before administering this drug.

How much should I give my child if they weigh between 24 and 35 lbs?

For children weighing 24 - 35 lbs (2 - 3 years), the recommended dose is 1 Single-Use Vial (5 mL).

What is the maximum number of doses I can give in 24 hours?

You should not give more than 5 doses in 24 hours.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Can I use this drug with other medications containing acetaminophen?

No, do not use this drug with any other medication containing acetaminophen, whether prescription or nonprescription.

What are the signs of a severe skin reaction?

Severe skin reactions may include skin reddening, blisters, or rash. If any of these occur, stop use and seek medical help immediately.

What should I do if my child's sore throat is severe?

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.

Is there any specific information regarding use during pregnancy?

The provided text does not include specific information regarding the use of this drug during pregnancy.

How should I store this medication?

Store the medication at 68-77ºF (20-25ºC) and do not use it if the top flap of the carton is open or if any vials are open or broken.

Packaging Info

Below are the non-prescription pack sizes of Childrens Pain and Fever (acetaminophen 160mg/5ml). 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 product is a combination of acetaminophen and ibuprofen, formulated as a clear, cherry-flavored liquid. Each 5 mL dose contains 160 mg of acetaminophen and 5 mg of ibuprofen. Inactive ingredients include citric acid, glycerin, high fructose corn syrup, maltodextrin, natural and artificial flavors, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, and xanthan gum. The SPL code for this product is 34089-3.

Uses and Indications

This drug is indicated for the temporary 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

For patients weighing under 24 lbs (under 2 years), it is recommended to consult a physician prior to administration. For those weighing between 24 and 35 lbs (ages 2 to 3 years), the appropriate dosage is 1 Single-Use Vial (5 mL). Patients weighing 36 to 47 lbs (ages 4 to 5 years) should also seek medical advice before administration. For children weighing between 48 and 71 lbs (ages 6 to 10 years), the dosage is 2 Single-Use Vials (10 mL). Finally, for patients weighing 72 to 95 lbs (11 years), the recommended dosage is 3 Single-Use Vials (15 mL).

The specific route and method of administration have not been detailed in the provided information. Healthcare professionals should ensure that the administration technique is appropriate for the patient's age and weight, following standard medical guidelines.

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.

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

Warnings and Precautions

Severe liver damage may occur in pediatric patients if more than 5 doses of this product, which contains acetaminophen, are administered within a 24-hour period. This dosage represents the maximum daily amount for this medication. Additionally, caution is advised when administering this product alongside other medications that also contain acetaminophen.

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 professionals should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a prompt consultation with a physician is warranted.

Prior to administration, it is essential to consult a healthcare provider if the child has a history of liver disease. Furthermore, if the child is concurrently taking the anticoagulant warfarin, it is advisable to seek guidance from a doctor or pharmacist before use.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond 5 days, fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed, as these may indicate a serious underlying condition.

In the event of an overdose, immediate medical attention is crucial. Parents and caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent. Prompt intervention is essential in such cases.

Side Effects

Severe liver damage may occur in patients if more than 5 doses of this product are taken within a 24-hour period, which is the maximum daily amount. Additionally, the risk of severe liver damage is heightened when this product is used in conjunction with other medications containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

A sore throat warning is also applicable; if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Patients are advised to stop use and seek medical advice if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Furthermore, it is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients in this formulation.

In the case of an overdose, it is critical to obtain medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential, 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 necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Pain and Fever (acetaminophen 160mg/5ml). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Pain and Fever.
Details

Pediatric Use

Pediatric patients require careful consideration when using this medication. For dosing, the following guidelines apply:

  • For children under 24 lbs and under 2 years of age, consultation with a doctor is advised before use.

  • For those weighing 24 to 35 lbs (ages 2 to 3 years), the recommended dose is 1 Single-Use Vial (5 mL).

  • Children weighing 36 to 47 lbs (ages 4 to 5 years) should also consult a doctor for appropriate dosing.

  • For children weighing 48 to 71 lbs (ages 6 to 10 years), the recommended dose is 2 Single-Use Vials (10 mL).

  • For those weighing 72 to 95 lbs (age 11 years), the recommended dose is 3 Single-Use Vials (15 mL).

Healthcare professionals should be aware of specific warnings associated with this medication. Parents or guardians should consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. Additionally, they should be advised to discontinue 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 redness or swelling occurs, as these may indicate a serious condition.

It is important to note that this medication should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Furthermore, it is contraindicated in children who are allergic to acetaminophen or any of the inactive ingredients in this product.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information primarily emphasizes pediatric use. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for geriatric patients.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects and therapeutic responses is advised, as individual patient factors may influence treatment outcomes.

Pregnancy

There is no specific information available regarding the use of DrKids Children's Pain and Fever (acetaminophen 160mg/5ml solution) during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been identified in the available information.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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.

Before administration, it is advisable for caregivers to consult a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the need for any dosage adjustments or additional monitoring based on the patient's specific liver function status.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Timely intervention is crucial, even in the absence of noticeable signs or symptoms. Healthcare professionals should be aware that prompt medical attention can significantly impact the outcome of an overdose situation.

It is essential to monitor the patient closely for any potential symptoms that may arise following an overdose. The specific symptoms can vary depending on the substance involved and the amount ingested. Therefore, a thorough assessment and appropriate management strategies should be implemented as soon as possible to mitigate any adverse effects.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important to emphasize that prompt medical attention is critical, even if the patient does not exhibit any signs or symptoms of overdose. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in a tamper-evident carton. It is essential to inspect the packaging before use; do not utilize the product if the top flap of the carton is open or if any vials are found to be open or broken.

For optimal storage, the product should be maintained at a temperature range of 68-77ºF (20-25ºC). Proper handling and adherence to these storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

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.

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.