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Childrens Pain and Fever

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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
73282-3164
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 drug is designed to help you feel better when you're experiencing discomfort from minor aches and pains, such as those caused by the common cold, flu, headache, sore throat, or toothache. Additionally, it temporarily reduces fever, making it a useful option when you're feeling unwell.

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 means that if you're feeling under the weather or experiencing mild pain, this medication can help make you feel more comfortable. Always remember to follow the recommended guidelines for use.

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 and are aged 2 to 3 years, you should use one Single-Use Vial, which contains 5 mL of the medication.

For children weighing between 36 and 47 pounds, who are 4 to 5 years old, you should also consult a doctor. If your child weighs between 48 and 71 pounds and is aged 6 to 10 years, you will need to use two Single-Use Vials, totaling 10 mL. Finally, for children who are 11 years old and weigh between 72 and 95 pounds, the dosage is three Single-Use Vials, which equals 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 contains 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 included in the formulation. Always prioritize safety and seek professional advice if you have any questions or concerns.

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, acetaminophen may cause 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 experiences a sore throat that is severe, 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 healthcare professional if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms develop, or if there is redness or swelling, as these could indicate a serious condition.

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 severe 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.

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 using the product and call 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. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Even if you don’t notice any signs or symptoms, getting prompt medical attention is crucial.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you experience any of these symptoms or are concerned about a possible overdose, don’t hesitate to reach out for help. 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 studied or documented in the drug insert.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before taking any medication, including over-the-counter options like acetaminophen. Your doctor can help you weigh the potential risks and benefits based on your individual health needs.

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 to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while 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 aged 6 to 10 years, weighing 48 to 71 pounds, the dose is two single-use vials (10 mL), and for an 11-year-old weighing 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. It's crucial to keep this medication out of reach of children and to seek immediate medical help in case of an overdose, even if there are no noticeable symptoms. Remember not to exceed the recommended dose, which should not be given more than five times in 24 hours or for more than five days unless directed by a doctor.

Geriatric Use

When it comes to using this product for older adults, there is no specific information available regarding its use in this age group. This means that the product does not include tailored directions or complete warnings that would typically help guide older adults or their caregivers in making informed decisions.

If you are considering this product for yourself or a loved one, it’s important to consult with a healthcare professional. They can provide personalized advice and ensure that any potential risks or considerations are addressed, especially since older adults may have unique health needs.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If your child has liver disease, it’s important to consult with a doctor before using this medication. Liver disease can affect how the body processes medications, so your healthcare provider will help determine if this treatment is safe and appropriate for your child. Always prioritize their health by seeking professional advice in these situations.

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 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 and check for tampering. Do not use the product if the top flap of the carton is open or if any vials are open or broken, as this could compromise safety. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What does this drug do?

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 24 - 35 lbs?

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

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

Do not give more than 5 doses in 24 hours.

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.

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 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.

Are there any warnings I should be aware of?

Yes, this product contains acetaminophen, which can cause severe liver damage if taken in excess or with other acetaminophen-containing drugs. It may also cause severe skin reactions.

Is there any information about using this drug during pregnancy?

There is no specific information provided regarding the use of this drug during pregnancy.

What should I do if my child's pain or fever worsens?

Stop use and ask a doctor if pain gets worse or lasts more than 5 days, or if fever gets worse or lasts more than 3 days.

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 identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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 to 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 to 71 lbs (ages 6 to 10 years), the dosage is 2 Single-Use Vials (10 mL). Finally, for patients weighing 72 to 95 lbs (ages 11 years and older), 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

This product contains acetaminophen, which poses a significant risk of severe liver damage if more than 5 doses are taken within a 24-hour period, the maximum daily amount for this medication. Additionally, caution is advised when administering this product alongside other medications that also contain acetaminophen.

Allergy Alert Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning Healthcare professionals should advise patients to consult a doctor if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

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

Monitoring and Discontinuation Patients should be instructed to stop use and consult a doctor if any of the following occur:

  • Pain worsens or persists beyond 5 days.

  • Fever worsens or lasts more than 3 days.

  • New symptoms develop.

  • Redness or swelling is observed, as these may indicate a serious condition.

Overdose Information In the event of an overdose, immediate medical attention is crucial. Patients or 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 vital for safety.

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 dosage of more than 5 doses in 24 hours is exceeded, or if the product is taken concurrently with other medications containing acetaminophen.

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious 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, it is recommended to consult a doctor promptly.

Furthermore, patients are advised to stop use and consult a healthcare professional 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.

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 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 regarding dosing and safety. For children under 24 lbs and under 2 years of age, it is advised to consult a doctor before use. For those weighing between 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), while those weighing 72 to 95 lbs (age 11 years) should receive 3 Single-Use Vials (15 mL).

Healthcare professionals should be aware of specific warnings when administering this medication to pediatric patients. It is important to consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin. Additionally, the product should be kept out of reach of children, and in the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222, as prompt attention is critical.

Usage instructions emphasize that the medication should not exceed the directed dose, with a maximum of 5 doses allowed within a 24-hour period. If possible, weight should be used to confirm the dose; otherwise, age may be utilized. The medication should not be administered for more than 5 consecutive days unless directed by a healthcare provider.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance tailored to geriatric populations. Additionally, the absence of directions or complete warnings for adult use suggests that caution should be exercised when considering this product for elderly patients.

Healthcare providers are advised to carefully evaluate the potential risks and benefits of administering this product to geriatric patients, particularly in the absence of established dosing guidelines or safety data. Monitoring for adverse effects and therapeutic efficacy is recommended in this population, given the potential for altered pharmacokinetics and increased sensitivity to medications in elderly individuals.

Pregnancy

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

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

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

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. Prompt medical attention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the management of an overdose may involve supportive care and symptomatic treatment, tailored to the specific circumstances and clinical presentation of the patient. Monitoring and assessment of vital signs, as well as laboratory evaluations, may be necessary to guide further management.

It is essential to maintain a high index of suspicion for potential complications, as the clinical manifestations of an overdose may not be immediately apparent. Therefore, early intervention and thorough evaluation are key components in the effective management of overdose cases.

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 that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, in cases of overdose, it is crucial to obtain medical help or contact a Poison Control Center promptly at 1-800-222-1222. Timely medical attention is essential, even if no signs or symptoms are apparent.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary, 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 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

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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.