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Childrens Pain and Fever

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Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
February 14, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Suspension
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 2015
Label revision date
February 14, 2024
Manufacturer
Best Choice (Valu Merchandisers Company)
Registration number
M013
NDC root
63941-288
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Drug Overview

Acetaminophen is a medication available in an oral suspension form, specifically designed for children aged 2 to 11. Each 5 mL dose contains 160 mg of acetaminophen and has a pleasant grape flavor. This medication is commonly used to temporarily relieve minor aches and pains, such as those caused by the common cold, flu, headaches, sore throats, and toothaches. Additionally, it helps to reduce fever.

Acetaminophen is alcohol-free, aspirin-free, and ibuprofen-free, making it a suitable option for many children. It is comparable to the active ingredient found in Children's Tylenol® Oral Suspension, providing effective relief for your child's discomfort.

Uses

You can use this medication to temporarily reduce fever and relieve minor aches and pains. It’s 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 pains, this medication can help you feel more comfortable for a short period. Always remember to follow the recommended guidelines for use.

Dosage and Administration

Before using this product, it's important to note that it does not come with complete directions or warnings for adults. Always make sure to shake the bottle well before each use. To measure your dose accurately, use only the enclosed dosing cup that comes with the product—other measuring devices may not provide the correct amount.

When it comes to how often you can take this medication, you can repeat the dose every 4 hours as long as your symptoms persist. However, you should not take more than 5 doses in a 24-hour period, and it's best not to use it for more than 5 days unless your doctor advises otherwise. To find the right dose, refer to the dosing chart based on your child's weight or age. For example, if your child weighs between 24-35 pounds and is 2-3 years old, the correct dose is 5 mL. Always consult the chart to ensure you are giving the appropriate amount.

What to Avoid

You should avoid using this medication if you are taking any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. If you're unsure about a medication's ingredients, it's important to consult with your doctor or pharmacist. Additionally, do not use this medication if your child is allergic to acetaminophen or any of its inactive ingredients.

It's crucial to follow the recommended dosage and not exceed it, as doing so can lead to serious health risks. Always be mindful of these guidelines to ensure safe use of the medication.

Side Effects

You should be aware that acetaminophen can lead to serious skin reactions, which may include symptoms like skin reddening, blisters, or rash. Additionally, taking more than five doses in a 24-hour period, or using it alongside other medications that contain acetaminophen, can result in severe liver damage.

If you experience a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, it’s important to consult a doctor. You should also stop using the medication and seek medical advice if you notice new symptoms, redness or swelling, worsening pain lasting more than five days, or a fever that persists for more than three days, as these could indicate a serious condition. In case of an overdose, which can also lead to liver damage, seek immediate medical help or contact a Poison Control Center.

Warnings and Precautions

It's important to be aware of some key warnings and precautions when using this medication. Acetaminophen can cause severe skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the medication immediately and seek medical help. Additionally, be cautious about the dosage; taking more than 5 doses in 24 hours or combining it with other products containing acetaminophen can lead to severe liver damage.

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. You should also stop using the medication and contact a doctor if new symptoms appear, if there is redness or swelling, or if pain or fever worsens or lasts longer than specified. In case of an overdose, seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, even if no symptoms are present. Always consult a doctor before use if your child has liver disease or is taking the blood-thinning medication warfarin.

Overdose

Taking more than the recommended dose of this medication can lead to serious liver damage. If you suspect an overdose, it’s important to seek medical help immediately, even if you don’t notice any symptoms. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Remember, quick action is crucial in these situations. Always prioritize your health and safety by getting help right away if you think you’ve taken too much.

Pregnancy Use

When it comes to using acetaminophen during pregnancy, there is currently no specific information available regarding its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using acetaminophen. They can help you weigh the potential benefits and risks based on your individual health needs. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your doctor before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's best to exercise caution when considering its use while breastfeeding.

Pediatric Use

When giving medication to children aged 2 to 11, it's important to follow specific dosing guidelines based on their weight. For children under 24 pounds, you should consult a doctor before use. For those weighing between 24 and 95 pounds, the dosage varies: 5 mL for 2-3 years, 7.5 mL for 4-5 years, 10 mL for 6-8 years, 12.5 mL for 9-10 years, and 15 mL for 11 years. Remember, you should not exceed 5 doses in a 24-hour period or use the medication for more than 5 days unless directed by a doctor.

It's also crucial to consult a doctor if your child has liver disease or is taking the blood thinner warfarin. Be aware of potential severe skin reactions, such as redness or blisters, and seek medical help if they occur. Additionally, if your child has a severe sore throat that lasts more than 2 days or is accompanied by other symptoms like fever or rash, contact a doctor right away.

Geriatric Use

While the drug insert for Children's Pain and Fever (acetaminophen suspension) does not provide specific information about its use in older adults, it is important to approach any medication with caution. Since there are no recommended age considerations, dosage adjustments, or safety concerns outlined for elderly patients, you should consult with a healthcare professional before using this medication. This ensures that it is appropriate for your needs and that any potential risks are managed effectively. Always prioritize safety and seek guidance tailored to your individual health situation.

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 may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If your child has liver disease, it's important to consult a doctor before using this product. It contains acetaminophen, which can be harmful to the liver. Be aware that giving your child more than 5 doses in a 24-hour period—this is the maximum daily amount—or combining it with other medications that also contain acetaminophen can lead to severe liver damage.

In case of an overdose, which means taking more than the recommended dose, liver damage may occur. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial, even if there are no immediate signs or symptoms.

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 contains 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 of your product, store it at room temperature, specifically between 20-25ºC (68-77ºF). It's important not to refrigerate the product, as this can affect its effectiveness. Always check the bottom panel for the lot number and expiration date to ensure you are using a valid and safe product.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. If you need to, you can repeat the dose every 4 hours while your symptoms persist, but make sure not to exceed 5 doses in a 24-hour period. Additionally, do not use this medication for more than 5 days unless your doctor advises you to do so.

FAQ

What is Acetaminophen used for?

Acetaminophen is a pain reliever and fever reducer that temporarily relieves minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

What is the recommended dosage for children?

The dosage varies by weight and age. For example, children weighing 24-35 lb (ages 2-3 years) should take 5 mL, while those weighing 72-95 lb (age 11 years) should take 15 mL.

Are there any warnings associated with Acetaminophen?

Yes, Acetaminophen may cause severe skin reactions and can lead to severe liver damage if more than 5 doses are taken in 24 hours or if combined with other acetaminophen-containing drugs.

Can I use Acetaminophen if my child has liver disease?

You should ask a doctor before using Acetaminophen if your child has liver disease.

Is Acetaminophen safe during pregnancy?

The insert does not provide specific information regarding the use of Acetaminophen during pregnancy, so consult a doctor for advice.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately, as quick medical attention is critical.

How should I store Acetaminophen?

Store Acetaminophen between 20-25ºC (68-77ºF) and do not refrigerate.

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

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.

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

Acetaminophen is formulated as an oral suspension containing 160 mg of acetaminophen per 5 mL. This preparation serves as a pain reliever and fever reducer. It is designed for pediatric use in children aged 2 to 11 years. The formulation is alcohol-free, aspirin-free, and ibuprofen-free, and it is flavored with grape to enhance palatability.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the temporary relief of minor aches and pains associated with conditions such as the common cold, influenza, headache, sore throat, and toothache.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age. It is essential to shake the product well before use. The enclosed dosing cup, specifically designed for this product, must be utilized; no other dosing devices should be employed.

The recommended dosing intervals are as follows: if necessary, the dose may be repeated every 4 hours while symptoms persist. However, it is crucial not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a physician.

The dosage chart is as follows:

  • For patients weighing under 24 lb or under 2 years of age, consultation with a doctor is advised.

  • For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 5 mL.

  • For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 7.5 mL.

  • For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 10 mL.

  • For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 12.5 mL.

  • For patients weighing 72-95 lb or aged 11 years, the recommended dose is 15 mL.

Healthcare professionals should ensure that patients do not exceed the maximum dosage and adhere to the guidelines provided to prevent any potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, 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.

  • Exceeding the recommended dosage is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

Acetaminophen may cause severe skin reactions, which can 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.

This product contains acetaminophen, and caution is warranted due to the risk of severe liver damage. Such damage may occur if a child exceeds five doses within a 24-hour period, which is the maximum recommended daily amount, or if acetaminophen is taken concurrently with other medications containing acetaminophen.

Healthcare professionals should be vigilant 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 physician promptly.

Patients should be advised to stop use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days. These symptoms may indicate a serious underlying condition.

In cases of suspected 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.

Prior to administration, it is advisable to consult a physician if the child has a history of liver disease. Additionally, healthcare providers should inquire about the use of blood-thinning medications, such as warfarin, before recommending this product.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, particularly those containing acetaminophen.

Severe skin reactions have been reported, which may manifest as skin reddening, blisters, or rash. These reactions necessitate immediate medical attention. Additionally, there is a significant risk of severe liver damage if the maximum daily dosage of acetaminophen is exceeded, 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.

Patients should be vigilant for symptoms indicating a serious condition. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. Furthermore, individuals should discontinue use and seek medical advice if new symptoms arise, if redness or swelling occurs, if pain worsens or lasts longer than five days, or if fever intensifies or persists beyond three days.

In cases of overdose, which may lead to liver damage, immediate medical assistance is crucial. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are apparent, as timely intervention is essential.

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 be heightened, leading to serious hepatic complications. 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 aged 2 to 11 years may receive dosing based on weight. For children under 24 lb (under 2 years), a healthcare professional should be consulted before use. The recommended dosages for children aged 2 to 11 years are as follows:

  • 24-35 lb (2-3 years): 5 mL

  • 36-47 lb (4-5 years): 7.5 mL

  • 48-59 lb (6-8 years): 10 mL

  • 60-71 lb (9-10 years): 12.5 mL

  • 72-95 lb (11 years): 15 mL

It is important to note that no more than 5 doses should be administered in a 24-hour period, and treatment should not exceed 5 days unless directed by a healthcare provider.

Caution is advised for pediatric patients with liver disease; consultation with a doctor is recommended prior to use. Additionally, if the child is taking the anticoagulant warfarin, a healthcare professional should be consulted before administration.

There is an allergy alert for acetaminophen, which may cause severe skin reactions, including symptoms such as skin reddening, blisters, or rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought.

A liver warning is also applicable, as severe liver damage may occur if the child exceeds 5 doses in 24 hours or if used concurrently with other medications containing acetaminophen.

Finally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Geriatric Use

There is no specific information regarding the use of Children's Pain and Fever (acetaminophen suspension) in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when considering the use of this medication in geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of individual patient needs. It is advisable to evaluate the overall health status and potential comorbidities of elderly patients before prescribing this medication.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are thoroughly evaluated.

Lactation

Nursing mothers are advised to consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of this product on a nursing infant are not well studied. Therefore, caution is advised when considering the use of this product during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert 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 there is no available data to guide appropriate dosing or monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The formulation contains acetaminophen, which poses a risk of severe liver damage if the patient exceeds five doses within a 24-hour period, as this represents the maximum daily dosage.

In cases of overdose, which may occur if the recommended dosage is surpassed, there is a significant risk of liver damage. Patients are advised to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) without delay, even in the absence of noticeable signs or symptoms. Prompt medical intervention is essential to mitigate potential harm.

Overdosage

Taking more than the recommended dose of the medication may lead to serious liver damage. 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.

Recommended Actions

Prompt medical attention is crucial, even if the individual does not exhibit any signs or symptoms of overdose. Healthcare professionals should be prepared to assess the patient's condition and initiate appropriate management procedures as necessary.

Potential Symptoms

While specific symptoms of overdose may not be detailed, the risk of liver damage underscores the importance of vigilance and timely intervention in cases of suspected overdose.

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, and rash. In the event of a skin reaction, it is advised to discontinue use and seek immediate medical assistance.

Additionally, reports indicate that severe liver damage may occur if a child exceeds five doses within a 24-hour period, which is the maximum recommended daily amount, or if acetaminophen is taken concurrently with other medications containing acetaminophen. Overdose situations, characterized by intake beyond the recommended dosage, may also lead to liver damage. In cases of suspected overdose, it is crucial to obtain medical help or contact a Poison Control Center (1-800-222-1222) promptly, as timely medical intervention is essential, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial even if no signs or symptoms are apparent.

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

It is important to instruct patients to avoid using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Patients should be advised to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days, as these may indicate a serious condition.

While using this product, patients must not exceed the recommended dosage, and they should be reminded of the overdose warning. Additionally, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. For traceability, the lot number and expiration date are located on the bottom panel of the packaging. Proper adherence to these storage conditions is crucial for maintaining product efficacy and safety.

Additional Clinical Information

The medication is administered orally, with the option to repeat the dose every 4 hours as needed while symptoms persist. Clinicians should advise patients not to exceed 5 doses within a 24-hour period and to limit use to a maximum of 5 days unless otherwise directed by a healthcare professional.

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.

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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.