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Basic Care 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 2021
Label revision date
May 6, 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 2021
Label revision date
May 6, 2024
Manufacturer
Amazon. com Services LLC
Registration number
M013
NDC root
72288-105
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Children’s Pain & Fever is an oral suspension liquid that contains acetaminophen (a common pain reliever and fever reducer) at a strength of 160 mg per 5 mL. It is designed specifically for children aged 2 to 11 years and provides fast, effective relief from minor aches and pains associated with conditions like the common cold, flu, headache, sore throat, and toothache.

This medication is free from aspirin, ibuprofen, alcohol, and parabens, making it a gentle option for your child. It comes in a pleasant bubblegum flavor and includes a dosage cup for easy measurement.

Uses

You can use this medication to help 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 medication is designed to provide you with relief when you're feeling under the weather, making it easier to manage everyday discomforts.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. To find the right dose for your child, refer to the dosage chart based on their weight or age. If your child weighs less than 24 pounds or is under 2 years old, it’s best to consult a doctor for the appropriate dose. For children weighing between 24 to 35 pounds (ages 2-3 years), the dose is 5 mL. If your child weighs 36 to 47 pounds (ages 4-5 years), the dose increases to 7.5 mL. For those weighing 48 to 59 pounds (ages 6-8 years), the dose is 10 mL, and for children weighing 60 to 71 pounds (ages 9-10 years), the dose is 12.5 mL. Finally, if your child weighs between 72 to 95 pounds (age 11 years), the dose is 15 mL.

When administering the medication, remove the child protective cap and squeeze the correct dose into the provided dosing cup. You can repeat this dose every 4 hours as long as your child continues to have symptoms, but remember not to give more than 5 doses in a 24-hour period. Always use the dosing cup that comes with the product, as other devices may not provide accurate measurements. If you have any questions or concerns, don’t hesitate to reach out to a healthcare professional.

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 whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this product if your child has ever had an allergic reaction to it or any of its ingredients.

It's also important to follow the recommended dosage carefully and not exceed it, as doing so can lead to serious health risks. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

This product 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, be aware that acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

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 use and contact a healthcare professional if pain worsens or lasts more than 5 days, fever persists for more than 3 days, new symptoms appear, or if there is redness or swelling, as these could indicate a serious condition.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Additionally, be aware that acetaminophen may cause serious skin reactions, such as redness, blisters, or rash. If you notice any skin reactions, 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 promptly.

Before using this medication, it's important to ask a doctor if your child has liver disease or is taking the blood-thinning medication warfarin. In case of an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222, even if there are no immediate symptoms. You should also stop using the product and call your doctor if your child's pain worsens or lasts more than 5 days, if a fever persists for more than 3 days, if new symptoms develop, or if there is any redness or swelling, as these may indicate a serious condition.

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 see any signs or symptoms, getting quick medical attention is crucial, as some effects may not be immediately apparent.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or have concerns about an overdose, don’t hesitate to reach out for help. Your safety is the top priority.

Pregnancy Use

When it comes to using acetaminophen during pregnancy, there is currently no specific information available about 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 situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

When considering this medication for your child, it's important to follow the recommended dosages based on their weight and age. For children under 2 years old and weighing less than 24 pounds, you should consult a doctor before administering the medication. For children aged 2 to 11 years, the dosage varies: if your child weighs between 24-35 pounds (2-3 years), give 5 mL; for 36-47 pounds (4-5 years), give 7.5 mL; for 48-59 pounds (6-8 years), give 10 mL; for 60-71 pounds (9-10 years), give 12.5 mL; and for those weighing 72-95 pounds (11 years), the dose is 15 mL.

Always ensure you are using the correct dosage for your child's weight and age to ensure their safety and effectiveness of the medication. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for guidance.

Geriatric Use

When considering this product, it's important to note that it does not provide specific directions or complete warnings for adult use, including older adults. This means that if you or a loved one is an older adult, you should consult with a healthcare professional before using this product to ensure it is safe and appropriate for your needs.

Always prioritize open communication with your doctor about any medications or treatments, especially if there are concerns related to age or health conditions. Your healthcare provider can help guide you on the best options tailored to your situation.

Renal Impairment

If your child has kidney problems, it's important to consult with a doctor before using this medication. Kidney issues can affect how your body processes certain drugs, so your healthcare provider may need to adjust the dosage or monitor your child's condition more closely. Always prioritize safety and ensure that any treatment plan is tailored to your child's specific health needs.

Hepatic Impairment

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

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 at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness. Before using the product, check the printed neckband; do not use it if the neckband is broken or missing, as this could indicate that the product is compromised.

Always handle the product with care to avoid any damage. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as symptoms persist, but do not exceed 5 doses in a 24-hour period. It's important to consult a doctor before use if your child has liver disease or is taking the blood thinner warfarin.

If your child's pain worsens or lasts more than 5 days, or if a fever worsens or lasts more than 3 days, stop using the medication and contact a doctor. Additionally, watch for any new symptoms or signs of redness and swelling. Always keep this medication out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Children's Pain & Fever?

Children's Pain & Fever is an oral suspension liquid containing acetaminophen 160 mg per 5 mL, designed to relieve pain and reduce fever in children aged 2 to 11.

What are the main uses of Children's Pain & Fever?

It reduces fever and relieves minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

What is the recommended dosage for Children's Pain & Fever?

Dosage varies by weight and age. For example, children aged 2-3 years weighing 24-35 lbs should take 5 mL, while those aged 11 years weighing 72-95 lbs should take 15 mL.

Are there any warnings associated with Children's Pain & Fever?

Yes, do not exceed 5 doses in 24 hours, and avoid using with other drugs containing acetaminophen. Severe liver damage may occur if these guidelines are not followed.

What should I do if my child experiences a skin reaction?

If your child develops symptoms like skin reddening, blisters, or rash, stop use immediately and seek medical help.

Can I use Children's Pain & Fever if my child has liver disease?

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

Is Children's Pain & Fever safe during pregnancy or breastfeeding?

The insert does not provide specific information regarding the use of acetaminophen during pregnancy or breastfeeding.

How should I store Children's Pain & Fever?

Store the product at 20-25°C (68-77°F) and do not use if the printed neckband is broken or missing.

What flavor does Children's Pain & Fever come in?

Children's Pain & Fever is available in a bubblegum flavor.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Packaging Info

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

Packaging configurations for Basic Care Childrens Pain and Fever.
Details

Drug Information (PDF)

This file contains official product information for Basic Care 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 presented in an oral suspension liquid form, containing 160 mg of acetaminophen per 5 mL. This formulation serves as a pain reliever and fever reducer. It is free from aspirin, ibuprofen, alcohol, and parabens, making it suitable for a wide range of patients. The product is flavored with bubblegum to enhance palatability. Each package contains 4 fluid ounces (118 mL) of the suspension, and a dosage cup is included for accurate measurement.

Uses and Indications

This drug is indicated for the 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

This product is intended for pediatric use only, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the child's weight or age. Prior to administration, the product must be shaken well to ensure proper mixing.

To administer the dose, the child protective cap should be removed, and the appropriate amount of liquid should be squeezed into the enclosed dosing cup. The recommended dosing intervals are every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period.

The following dosage chart provides specific dosing recommendations:

  • For children weighing under 24 lb or under 2 years of age, consult a doctor for the appropriate dose.

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

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

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

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

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

It is imperative to adhere strictly to the dosing recommendations and not exceed the maximum dosage to avoid the risk of overdose. Only the enclosed dosing cup should be used for measurement; other dosing devices are not suitable for this product.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication 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.

Additionally, this product is contraindicated in patients who have a history of allergic reactions to this product or any of its ingredients.

Exceeding the recommended dosage is also contraindicated, as it may lead to serious adverse effects.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen.

Acetaminophen may also lead to 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.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional without delay.

Healthcare professionals should advise caregivers to consult a doctor prior to administering this product if the child has a history of liver disease. Additionally, it is recommended to seek guidance from a doctor or pharmacist if the child is currently taking the anticoagulant warfarin.

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

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: worsening pain that lasts more than 5 days, worsening fever that persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires medical evaluation.

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 maximum daily dosage of acetaminophen, which is five doses within a 24-hour period, or who take this product in conjunction with other medications containing acetaminophen.

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

Patients should also be 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 crucial to consult a healthcare professional promptly.

Patients are advised to stop using the product and seek medical advice if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if new symptoms arise, or if there is any redness or swelling present. These symptoms may indicate a serious underlying condition that requires medical evaluation.

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. Co-administration may lead to an increased risk of acetaminophen-related toxicity. 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 Basic Care Childrens Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Basic Care Childrens Pain and Fever.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may use this product, with specific dosing guidelines based on weight and age. For children under 24 pounds and under 2 years of age, it is advised to consult a doctor before use.

For those weighing between 24 to 35 pounds (ages 2 to 3 years), the recommended dose is 5 mL. Children weighing 36 to 47 pounds (ages 4 to 5 years) should receive 7.5 mL. For patients weighing 48 to 59 pounds (ages 6 to 8 years), the appropriate dose is 10 mL. Those weighing 60 to 71 pounds (ages 9 to 10 years) should be administered 12.5 mL, while children weighing 72 to 95 pounds (age 11 years) may receive a dose of 15 mL.

Healthcare professionals should ensure adherence to these dosing recommendations to optimize safety and efficacy in pediatric patients.

Geriatric Use

Elderly patients may not receive comprehensive guidance or warnings regarding the use of this product, as the labeling does not include specific directions or complete warnings for adult use. Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the potential for increased sensitivity to the medication and the likelihood of comorbidities that may affect safety and efficacy.

It is advisable for healthcare providers to closely monitor elderly patients for any adverse effects and to consider individual patient factors when determining the appropriateness of this product for use in this population.

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 adequately assessed.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a concurrent liver disease. It is essential to assess the patient's overall renal function and consider any necessary dosing adjustments or monitoring protocols based on the severity of renal impairment.

Hepatic Impairment

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

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential, as quick medical attention can significantly impact the outcome, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious complications. Therefore, monitoring and evaluation should be conducted as soon as possible following an overdose incident.

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 immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical attention in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222, as prompt medical intervention is crucial, even if no signs or symptoms are apparent.

Patients must be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be encouraged to consult with a doctor or pharmacist.

It is essential to inform patients that this product should not be used if their child has a history of allergic reactions to this product or any of its ingredients. Healthcare providers should instruct patients to discontinue use and consult a doctor if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients should be reminded to adhere strictly to the recommended dosage to avoid the risk of overdose. Additionally, healthcare providers should advise patients to consult a doctor before using this product if their child has liver disease. It is also important to recommend that patients speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed neckband is broken or missing, as this may indicate potential tampering or compromise of the product's safety. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for patient use.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to consult a doctor before use if the child has liver disease or is taking warfarin, a blood-thinning medication. Patients should discontinue use and seek medical advice if 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. It is crucial to keep the medication out of reach of children, and in the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) should be made.

Drug Information (PDF)

This file contains official product information for Basic Care 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 Basic Care 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.