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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
73282-1164
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 drug is commonly used for discomfort associated with conditions like the common cold, flu, headaches, sore throats, and toothaches.

By working to lower your body temperature and alleviate pain, this medication can help you feel more comfortable when you're not feeling your best. It's a supportive option for managing everyday aches and fever.

Uses

You can use this medication to temporarily reduce fever and relieve minor aches and pains. It is effective for discomfort caused by various conditions, including the common cold, flu, headache, sore throat, and toothache.

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 consult with a doctor before giving any medication. For children who weigh between 24 and 35 pounds, typically aged 2 to 3 years, you can use one 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 talk to a doctor for guidance. If your child weighs between 48 and 71 pounds, generally aged 6 to 10 years, you will need to use two Single-Use Vials, totaling 10 mL. Finally, for children who weigh between 72 and 95 pounds, around 11 years old, the dosage is three Single-Use Vials, which equals 15 mL. Remember, each vial is designed for one-time use only.

What to Avoid

You should avoid using this medication if you or your child are allergic to acetaminophen or any of the inactive ingredients in the product. Additionally, do not take this medication alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, it's important to consult with a doctor or pharmacist for clarification.

Be mindful that mixing medications can lead to serious health risks, so always check labels and ask for help if needed. Your safety is the top priority, so please follow these guidelines closely.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. There is a risk of severe liver damage if your child takes more than 5 doses in 24 hours or uses other products containing acetaminophen. Additionally, some children may experience severe skin reactions, which can 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's sore throat 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 seek medical advice 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. Always check with a doctor or pharmacist before use if your child is taking warfarin (a blood thinner) or has liver disease.

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 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. In case of an overdose, get medical help or contact a Poison Control Center at 1-800-222-1222, even if there are no immediate signs or symptoms. You should also stop using the product and call your 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. Always consult a doctor or pharmacist before use if your child is taking the blood thinner warfarin or has liver disease.

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 else is experiencing these symptoms, don’t hesitate to reach out for help right away. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this product during pregnancy. The insert does not mention any risks or contraindications associated with using acetaminophen while pregnant, and it does not specify any dosage modifications for pregnant individuals. Additionally, there are no special precautions outlined for its use in this context.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

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

Pediatric Use

When giving medication to your child, it's important to follow the recommended dosage carefully. Use the provided dosing chart to confirm the correct amount based on your child's weight or age. For children under 24 pounds or under 2 years old, consult a doctor before administering the medication. For those aged 2-3 years weighing between 24-35 pounds, the dose is 5 mL (1 Single-Use Vial). If your child is 4-5 years old and weighs 36-47 pounds, again, talk to a doctor. For children aged 6-10 years weighing 48-71 pounds, the dose is 10 mL (2 Single-Use Vials), and for an 11-year-old weighing 72-95 pounds, the dose is 15 mL (3 Single-Use Vials).

Be cautious not to exceed the maximum daily dose of 5 doses in 24 hours, as this can lead to severe liver damage, especially since this medication contains acetaminophen. Do not use it for more than 5 days unless directed by a doctor. If your child experiences worsening pain, fever lasting more than 3 days, or any new symptoms, stop use and consult a doctor immediately. In case of overdose, seek medical help or contact a Poison Control Center right away, even if there are no immediate signs of trouble. Always check with a doctor if your child has liver disease before using this medication.

Geriatric Use

While there is no specific information about the use of this product in older adults, it is primarily designed for children. This means that there are no recommended dosage adjustments or special safety precautions for elderly patients. However, as with any medication, it’s always a good idea for you or your caregiver to consult with a healthcare professional before starting any new treatment, especially if there are existing health concerns or other medications being taken. Your health and safety should always come first.

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 you understand how to manage your treatment effectively while considering your kidney health.

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 to ensure their safety and proper care.

Monitoring your child's dosage and seeking medical advice can help prevent potential complications related to liver health. Always keep track of any other medications that may also contain acetaminophen, as combining them can increase the risk of liver damage.

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 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 crucial for your safety, so always inspect it before use.

Additional Information

No further information is available.

FAQ

What is the general use of this drug?

This drug temporarily reduces fever and relieves minor aches and pains due to conditions like 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.

What is the recommended dosage for a child weighing 24-35 lbs?

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

How often can I repeat the dose?

You can repeat the dose every 4 hours while symptoms last, but do not give more than 5 doses in 24 hours.

What are the contraindications for this drug?

Do not use this drug with any other medication containing acetaminophen or if your child is allergic to acetaminophen or any inactive ingredients in this product.

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

Is this drug safe to use during pregnancy?

There is no specific information provided regarding the use of this product during pregnancy, and no contraindications are mentioned.

Can nursing mothers use this drug?

The insert does not provide specific warnings or recommendations regarding the use of this product in nursing mothers.

How should I store this drug?

Store the drug at 68-77ºF (20-25ºC) and do not use 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). 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 drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the other. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, talc, D&C Yellow No. 10, and FD&C Red No. 40.

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), consultation with a healthcare professional is recommended prior to administration. For those weighing between 24-35 lbs (ages 2-3 years), the appropriate dosage is 1 Single-Use Vial (5 mL). Patients weighing 36-47 lbs (ages 4-5 years) should also seek guidance from a healthcare provider. For children weighing 48-71 lbs (ages 6-10 years), the dosage is 2 Single-Use Vials (10 mL). Finally, for patients weighing 72-95 lbs (ages 11 years), the recommended dosage is 3 Single-Use Vials (15 mL).

The medication is to be administered using Single-Use Vials. It is essential that healthcare professionals follow the specified dosing guidelines and consult with a physician when necessary to ensure safe and effective use.

Contraindications

Use of this product is contraindicated in the following situations:

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

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

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if the maximum daily dosage of 5 doses within a 24-hour period is exceeded, or if it is used concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to strictly adhere to dosing guidelines to mitigate this risk.

Acetaminophen may also trigger severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat 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 essential to rule out serious underlying conditions.

In the event of an overdose, immediate medical attention is crucial. Caregivers should be instructed to contact a Poison Control Center at 1-800-222-1222, even if no signs or symptoms are apparent, as prompt intervention can be critical.

Healthcare professionals should advise caregivers 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 develop.

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

Before administering this product, it is advisable to consult a healthcare provider if the child is currently taking the anticoagulant warfarin, as potential interactions may necessitate closer monitoring. Additionally, a consultation is warranted if the child has a history of liver disease, to ensure safe use of acetaminophen.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Participants should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek immediate medical assistance.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

It is advised that patients stop use and contact a doctor if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Before using this product, patients should consult a doctor or pharmacist if they are taking the blood-thinning medication warfarin or if they have a history of liver disease.

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 may arise from unintentional duplication of therapy. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

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

Packaging configurations for Childrens Pain and Fever.
Details

Pediatric Use

Pediatric patients should not exceed the recommended dosage, as outlined in the overdose warning. It is essential to confirm the appropriate dose using the provided dosing chart, prioritizing weight when possible; otherwise, age may be used as a guide.

Dosing Chart:

  • For patients under 24 lbs or under 2 years, consultation with a doctor is advised.

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

  • For patients weighing 36-47 lbs (4-5 years), a doctor's consultation is necessary.

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

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

Treatment should not exceed 5 days unless directed by a healthcare professional. Caution is warranted due to the presence of acetaminophen, as severe liver damage may occur if more than 5 doses are taken within a 24-hour period, which is the maximum daily amount.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222, as prompt attention is critical even in the absence of symptoms.

Healthcare providers should inquire about any pre-existing liver conditions before administration. If pain worsens or persists beyond 5 days, fever intensifies or lasts more than 3 days, new symptoms arise, or signs of redness or swelling occur, a doctor should be consulted, as these may indicate a serious condition.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as it is primarily intended for pediatric populations. There are no dosage adjustments, safety concerns, or special precautions indicated for geriatric patients. Therefore, healthcare providers should consider the lack of data when prescribing this product to elderly patients and monitor for any potential adverse effects, given the absence of established guidelines for this demographic.

Pregnancy

There is no specific information available regarding the use of this product during pregnancy. The prescribing information does not mention any contraindications or risks associated with the use of acetaminophen in pregnant patients. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not include any special precautions regarding the use of this product in this population. 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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 conjunction with other medications containing acetaminophen, may significantly increase the risk of liver injury.

Before administering this product, it is advisable to consult a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safety and efficacy of the treatment in patients with compromised liver function.

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 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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing that prompt medical attention is critical even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is essential to discuss the potential for allergic reactions, particularly in children who may be allergic to acetaminophen or any of the inactive ingredients in the product.

Patients should be instructed to discontinue use and consult a doctor if pain worsens or persists for more than 5 days, or if fever worsens or lasts more than 3 days. Additionally, they should stop use and seek medical advice if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Finally, healthcare providers should recommend that patients consult a doctor or pharmacist before use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a tamper-evident carton. It is essential to inspect the carton before use; do not use 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.