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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 21, 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 21, 2023
Manufacturer
CalmCo LLC
Registration number
part343
NDC root
73282-2116
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to help you feel better when you're experiencing discomfort from minor aches and pains, such as those caused by the common cold, flu, headache, sore throat, or toothache. Additionally, it can temporarily reduce fever, providing relief when you're feeling unwell.

By targeting these symptoms, this drug aims to improve your overall comfort and help you manage the effects of common illnesses.

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 between 2 and 3 years old, you should use 1 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 for guidance. If your child weighs between 48 and 71 pounds and is between 6 and 10 years old, the recommended dosage is 2 Single-Use Vials, totaling 10 mL. Finally, for children who are 11 years old and weigh between 72 and 95 pounds, you should administer 3 Single-Use Vials, which equals 15 mL. Always ensure you follow these guidelines closely to provide the best care for 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 in the medication. 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 take it with other medications that contain 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 you notice any of these skin reactions, 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 important to stop using the medication and ask a doctor if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms appear, or if there is redness or swelling. Lastly, avoid using this medication with any other acetaminophen-containing products and seek immediate medical attention in case of an overdose, 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 severe skin reactions, such as 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 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 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.

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 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

If you are pregnant or planning to become pregnant, it's important to be cautious with any medications, including acetaminophen. Currently, there is no specific information available about the safety of using acetaminophen during pregnancy, which means that guidelines on dosage or any necessary precautions are not provided.

Before taking acetaminophen or any other medication, you should consult with your healthcare provider to discuss potential risks and benefits tailored to your individual situation. Your health and the health of your baby are paramount, so always seek professional advice when it comes to medication use during pregnancy.

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

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 1 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 2 Single-Use Vials (10 mL), and for those who are 11 years old and weigh 72 to 95 pounds, the dose is 3 Single-Use Vials (15 mL).

Before giving this medication, check with your doctor if your child has liver disease or is taking warfarin, a blood-thinning medication. You should also stop use and consult a doctor if your child's pain worsens or lasts more than 5 days, if their fever worsens or lasts 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 related to 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. Combining these medications can increase the risk of bleeding, so ensuring that your healthcare provider is aware of all medications your child is taking is crucial for their safety. Always prioritize open communication about any treatments or tests to avoid potential interactions.

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). This helps maintain its effectiveness.

When handling the product, be sure to check the packaging carefully. 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 inspect it 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 should I dose 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.

Are there any warnings for using this drug?

Yes, do not use this drug with any other product containing acetaminophen, and consult a doctor if your child has liver disease or is taking warfarin.

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

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 allergy alerts associated with this drug?

Acetaminophen may cause severe skin reactions, including skin reddening, blisters, and rash. If a skin reaction occurs, stop use and seek medical help immediately.

Is there any information about using this drug during pregnancy or while nursing?

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

How should I store this drug?

Store the drug at 68-77ºF (20-25ºC) and do not use if the carton is tampered with 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, red liquid with a cherry flavor. 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. It also provides relief from 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 (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; therefore, healthcare professionals should refer to additional guidelines or product information for these details.

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, 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.

In cases of severe sore throat that persists for more than 2 days or is accompanied by additional symptoms such as 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, to avoid potential interactions.

Discontinuation of the product and consultation with a healthcare provider is warranted if any of the following occur: worsening pain that lasts longer than 5 days, worsening fever that persists beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious medical 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 vital.

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 concurrently 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.

In cases where a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should stop use and consult a doctor if pain worsens or lasts longer than 5 days, if fever worsens or lasts longer 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. It is also contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients in this formulation.

In the event of an overdose, it is crucial to seek 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 immediately 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 interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to bleeding. 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 under 2 years of age who weigh less than 24 lbs should consult a doctor before use. For children aged 2 to 3 years weighing between 24 and 35 lbs, the recommended dose is 1 Single-Use Vial (5 mL). Pediatric patients aged 4 to 5 years who weigh between 36 and 47 lbs should also consult a doctor prior to administration. For those aged 6 to 10 years weighing between 48 and 71 lbs, the recommended dose is 2 Single-Use Vials (10 mL). Children aged 11 years and weighing between 72 and 95 lbs should receive 3 Single-Use Vials (15 mL).

Healthcare professionals should advise parents to seek medical guidance if the child has liver disease or is taking the blood-thinning medication warfarin. Additionally, parents should be instructed to discontinue use and consult a doctor 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, 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. It is also contraindicated in children with a known allergy to acetaminophen or any of the inactive ingredients in this formulation.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information primarily emphasizes pediatric use and does not provide any recommendations concerning age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the absence of data on its safety and efficacy in this population. It is advisable to monitor elderly patients closely for any adverse effects or unusual responses to treatment, considering the potential for altered pharmacokinetics and increased sensitivity to medications in this age group.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending acetaminophen to women of childbearing potential. Further research may be necessary to fully understand the implications of acetaminophen use during pregnancy and its potential effects on fetal outcomes.

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 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 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 and the substance involved. Continuous monitoring of the patient’s vital signs and clinical status is recommended to identify any potential complications that may arise.

It is essential to maintain a high index of suspicion for overdose, as symptoms may not be immediately apparent. Therefore, proactive measures and timely intervention are vital in ensuring patient safety and effective management of the situation.

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 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.