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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
73282-2164
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 dealing with everyday aches, this medication can help provide some relief. Always remember to follow the recommended guidelines for use.

Dosage and Administration

If your child weighs less than 24 pounds and is under 2 years old, it's important to consult a doctor for the appropriate dosage. For children who weigh between 24 and 35 pounds and are aged 2 to 3 years, the recommended dose is one single-use vial, which contains 5 mL of the medication.

For children weighing between 36 and 47 pounds, aged 4 to 5 years, you should also talk to a doctor to determine the right dosage. If your child weighs between 48 and 71 pounds and is aged 6 to 10 years, the dosage increases to two single-use vials, totaling 10 mL. Finally, for children who weigh between 72 and 95 pounds and are 11 years old, the recommended dose is three single-use vials, which amounts to 15 mL. Always follow your healthcare provider's guidance for the best care.

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

You should be aware of some important side effects and warnings associated with 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 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 may 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 a 24-hour period or uses other medications that also contain acetaminophen. It's important to be aware that acetaminophen may cause serious skin reactions, such as redness, blisters, or rashes. 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.

In case of an overdose, it is crucial to get medical help or contact a Poison Control Center immediately at 1-800-222-1222, even if there are no noticeable signs or symptoms. Prompt attention is essential.

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

While there are no specific warnings or dosage changes mentioned for using this product during pregnancy, it's important to note that the insert does not clarify whether it is safe for use or if there are any risks to your developing baby. Additionally, there is no information provided about the safety of acetaminophen (a common pain reliever) during pregnancy.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication. They can help you understand 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 it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When giving this medication to your child, it's important to follow the dosing guidelines based on their weight and age. For children under 24 pounds or under 2 years old, you should talk to a doctor before use. If your child weighs between 24 and 35 pounds (ages 2 to 3 years), the recommended dose is 1 Single-Use Vial (5 mL). For those weighing 36 to 47 pounds (ages 4 to 5 years), consult a doctor. Children who weigh between 48 and 71 pounds (ages 6 to 10 years) can take 2 Single-Use Vials (10 mL), and those who weigh 72 to 95 pounds (11 years old) can take 3 Single-Use Vials (15 mL).

Be aware of some important warnings. If your child takes more than 5 doses in 24 hours, it could lead to severe liver damage. Always consult a doctor if your child has liver disease or is taking the blood thinner warfarin. Additionally, if your child's pain worsens or lasts more than 5 days, or if their fever persists for more than 3 days, stop use and consult a doctor. New symptoms or signs of redness and swelling should also prompt a call to a healthcare professional, as these could indicate a more serious issue.

Geriatric Use

When it comes to using this product for older adults, there is no specific information available regarding its safety or effectiveness. This means that the product does not have tailored guidelines or warnings for elderly patients. If you are caring for an older adult, it’s important to consult with a healthcare professional before starting any new medication, especially since older adults may have different health needs and may be taking other medications that could interact. Always prioritize safety and seek personalized advice to ensure the best care.

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 plan.

Hepatic Impairment

If your child has liver problems, it's important to be cautious with medications that contain acetaminophen. Taking more than 5 doses in a 24-hour period can lead to severe liver damage, 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. 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 68-77ºF (20-25ºC). It's important to check the packaging before use; do not use the product if the top flap of the carton is open or if any vials are open or broken, as this indicates potential tampering or damage.

Always handle the product with care to maintain its integrity. Following these guidelines will help ensure that 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.

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned for this drug.

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

If your child weighs under 24 lbs and is under 2 years old, you should talk to a doctor for dosing instructions.

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

For children weighing 24 to 35 lbs (ages 2 to 3 years), the dose is 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.

What are the signs of a severe skin reaction?

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

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. Prompt medical attention is critical.

Are there any specific warnings for pediatric use?

Yes, there are warnings regarding liver damage if more than 5 doses are taken in 24 hours, and you should consult a doctor if your child has liver disease.

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 specific description details are provided in the text.

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 and under 2 years of age, it is recommended that healthcare professionals consult a physician to determine the appropriate dosage.

For patients weighing between 24 and 35 lbs, aged 2 to 3 years, the recommended dosage is 1 Single-Use Vial (5 mL).

For patients weighing between 36 and 47 lbs, aged 4 to 5 years, it is advised to consult a physician to establish the correct dosage.

For patients weighing between 48 and 71 lbs, aged 6 to 10 years, the recommended dosage is 2 Single-Use Vials (10 mL).

For patients weighing between 72 and 95 lbs, aged 11 years, the recommended dosage is 3 Single-Use Vials (15 mL).

Healthcare professionals should ensure that the appropriate dosage is administered based on the patient's weight and age, and should follow any specific preparation or administration techniques as outlined in the prescribing information.

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 with the use of this product, which contains acetaminophen, if a child exceeds 5 doses within a 24-hour period, the maximum daily amount, or if used concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to mitigate the risk of liver injury.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

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, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

Prior to administration, it is essential to consult a healthcare professional if the child has a history of liver disease. Additionally, caregivers should seek advice from a doctor or pharmacist if the child is currently taking warfarin, a blood-thinning medication, due to potential interactions.

Discontinuation of the product and consultation with a healthcare provider is warranted if any of the following occur: pain worsens or lasts longer than 5 days, fever worsens or persists beyond 3 days, new symptoms develop, or if redness or swelling is observed, as these may indicate a serious condition.

In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as prompt intervention is critical.

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 recommended dosage of acetaminophen, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen.

Additionally, there is a risk of severe skin reactions associated with acetaminophen use. Symptoms of such reactions may 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 two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

Furthermore, patients are advised to stop using the product and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if new symptoms develop, or if there is any redness or swelling, 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 pediatric patients 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).

Warnings specific to pediatric use include a liver warning, indicating that severe liver damage may occur if more than 5 doses are taken within a 24-hour period, which is the maximum daily amount for this product. It is essential to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. Parents and caregivers should discontinue use and seek medical advice if the child's 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.

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 this population. Additionally, the absence of directions or complete warnings for adult use suggests that caution should be exercised when considering this product for geriatric patients.

Healthcare providers are advised to carefully evaluate the potential risks and benefits when prescribing this product to elderly patients, taking into account the lack of established safety and efficacy data in this demographic. Monitoring for adverse effects and adjusting dosages as necessary may be prudent in the management of treatment in geriatric patients.

Pregnancy

There are no specific warnings, precautions, or dosage modifications regarding the use of this product during pregnancy. The available data does not indicate whether the product is contraindicated in pregnancy or if there are any associated risks to the fetus. Additionally, no information is provided concerning safety concerns related to the use of acetaminophen during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

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 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 these patients to ensure safety and efficacy.

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 to mitigate the risk of hepatotoxicity.

Before administration, it is advised that a healthcare professional be consulted 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 potential need for dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

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 of the patient. Continuous monitoring and assessment of the patient's condition are essential to ensure appropriate interventions are implemented as needed.

It is recommended that healthcare providers remain vigilant for any potential symptoms that may arise following an overdose, as early recognition and intervention can significantly impact 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 limits the assessment of potential risks associated with the compound in these areas.

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 and seek medical assistance immediately.

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 an 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

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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.