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Foster and Thrive 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 2023
Label revision date
September 19, 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 2023
Label revision date
September 19, 2024
Manufacturer
Strategic Sourcing Services LLC
Registration number
M013
NDC root
70677-1142
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

Children’s Pain & Fever is an oral suspension that contains acetaminophen (160 mg per 5 mL) and is designed to provide fast and effective relief from fever and minor aches and pains in children aged 2 to 11. This medication can help alleviate discomfort caused by common conditions such as the cold, flu, headaches, sore throats, and toothaches.

With a pleasant bubble gum flavor, it comes with a dosing cup for easy administration. Importantly, it is free from parabens, aspirin, ibuprofen, alcohol, and gluten, making it a suitable option for many children.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It is effective for discomfort caused by various conditions, including the common cold, flu, headaches, sore throats, and toothaches.

This means that if you're feeling under the weather or experiencing mild pain, this medication can provide some relief to help you feel better.

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 dosing chart based on their weight or age. If your child weighs under 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 enclosed dosing cup. You can repeat this dose every 4 hours as long as your child continues to have symptoms, but remember not to exceed 5 doses in a 24-hour period. Always use the dosing cup that comes with the product, as other devices may not provide the correct measurement.

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, it's important to consult with 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 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

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 combines it with other medications containing acetaminophen, there is a risk of severe liver damage. Additionally, be cautious of potential severe skin reactions, which may 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 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 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, 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. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any skin reactions, stop using the product and seek medical help immediately. Additionally, 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, 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 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, as these may indicate a serious condition.

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. Quick action is crucial, even if you don’t see 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 notice any of these symptoms or have concerns about an overdose, don’t hesitate to get help right away. Your safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of acetaminophen during pregnancy has not been clearly established. There may be potential risks to your fetus, but these risks are not well defined, so caution is advised. Before using acetaminophen, you should consult your doctor to discuss your specific situation.

While there are no specific dosage modifications for pregnant individuals, it is always best to seek guidance from a healthcare professional regarding any medication use during pregnancy. Remember to approach the use of acetaminophen with care and have an open conversation with your healthcare provider about your options.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, and the effects of acetaminophen on nursing infants haven't been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

If you do take this medication, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help you weigh the benefits and risks to ensure the safety of both you and your child.

Pediatric Use

When giving this medication to children, it's important to follow specific guidelines based on their weight and age. For children under 2 years old who weigh less than 24 pounds, you should consult a doctor before use. For those aged 2 to 11 years, the recommended doses are as follows: children weighing 24-35 pounds (ages 2-3) should receive 5 mL, those weighing 36-47 pounds (ages 4-5) should get 7.5 mL, children weighing 48-59 pounds (ages 6-8) should take 10 mL, those weighing 60-71 pounds (ages 9-10) should have 12.5 mL, and children weighing 72-95 pounds (age 11) should receive 15 mL.

Always use the dosing cup that comes with the medication, as it is specifically designed for accurate measurement. Avoid using any other dosing devices to ensure your child receives the correct amount.

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 be particularly cautious and consult with a healthcare professional before using it.

Always ensure that any medication or treatment is appropriate for your individual health needs, especially as you may have different considerations compared to younger adults. Your healthcare provider can help guide you on the best options and any necessary precautions.

Renal Impairment

If your child has liver disease, it's important to consult with a doctor before using this medication. This ensures that the treatment is safe and appropriate for their specific health needs. Always prioritize open communication with healthcare providers to manage any potential risks effectively.

Hepatic Impairment

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

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 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.

By following these simple storage and handling guidelines, you can help ensure that your product remains safe and effective for use.

Additional Information

You should take this medication orally. It's important to keep it out of reach of children to prevent accidental ingestion. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial, even if you don't notice any signs or symptoms of overdose.

FAQ

What is Children's Pain & Fever?

Children's Pain & Fever is an oral suspension containing acetaminophen 160 mg per 5 mL, designed to provide fast and effective relief of fever and minor aches and pains in children aged 2 to 11.

What are the indications for using Children's Pain & Fever?

It is used to reduce fever and relieve 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, severe liver damage may occur if more than 5 doses are taken in 24 hours or if taken with other acetaminophen-containing products. Additionally, it may cause severe skin reactions.

Can I use Children's Pain & Fever if my child is pregnant or breastfeeding?

Consult a doctor before use if pregnant or planning to become pregnant. Nursing mothers should also consult a doctor, as acetaminophen may be excreted in breast milk.

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.

Is Children's Pain & Fever safe for children with liver disease?

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

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

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

What should I do if my child's symptoms persist?

Stop use and consult a doctor if pain worsens or lasts more than 5 days, or if fever worsens or lasts more than 3 days.

Packaging Info

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

Packaging configurations for Foster and Thrive Childrens Pain and Fever.
Details

Drug Information (PDF)

This file contains official product information for Foster and Thrive 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 is designed for the fast and effective relief of fever and pain in children aged 2 to 11 years. The product is free from parabens, aspirin, ibuprofen, alcohol, and gluten, making it suitable for a wide range of pediatric patients. It is presented in a bubble gum flavor to enhance palatability and is supplied with a dosing cup for accurate administration. The total volume of the suspension is 4 fluid ounces (118 mL).

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 below to determine the appropriate dose based on the child's weight or age. It is essential to shake the product well before each use.

To administer the dose, remove the child protective cap and squeeze the appropriate amount 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.

Dosage Chart:

  • For children weighing under 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

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

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

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

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

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

It is critical not to exceed the recommended dosage, and healthcare professionals should be aware of the overdose warning associated with this product. Only the enclosed dosing cup should be used for measurement; no other dosing devices are permitted.

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. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

This product is contraindicated in patients with a known history of allergic reactions to this product or any of its components.

Additionally, it is essential to adhere to the recommended dosage, as exceeding this may lead to overdose.

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 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 if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should inquire about the presence of liver disease before recommending this product for children. Additionally, it is essential to consult a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: worsening pain lasting more than 5 days, worsening fever lasting 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 further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of five doses within a 24-hour period. This risk is further heightened if the product is taken concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

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

Patients should also discontinue use and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or persists beyond three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious underlying condition.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. 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 Foster and Thrive Childrens Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Foster and Thrive Childrens Pain and Fever.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 to 3 years, the recommended dose is 5 mL for those weighing between 24-35 pounds. For children aged 4 to 5 years, the dose increases to 7.5 mL for those weighing 36-47 pounds. Children aged 6 to 8 years should receive 10 mL if they weigh between 48-59 pounds, while those aged 9 to 10 years should be given 12.5 mL for a weight range of 60-71 pounds. For an 11-year-old weighing between 72-95 pounds, the appropriate dose is 15 mL.

It is crucial to use only the enclosed dosing cup specifically designed for this product and to avoid using any other dosing device to ensure accurate administration.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. Healthcare providers should exercise caution when prescribing this product to geriatric patients, ensuring that they assess the individual needs and potential risks associated with its use in this population. Monitoring for adverse effects and therapeutic efficacy is recommended, as the absence of specific guidance may necessitate tailored dosing or additional safety measures.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. While potential risks to the fetus are not clearly defined, caution is advised when considering the use of acetaminophen during pregnancy. There are no specific dosage modifications recommended for pregnant individuals; therefore, it is essential to seek guidance from a healthcare provider regarding appropriate use. Overall, the use of acetaminophen during pregnancy should be approached with caution, and discussions with a healthcare provider are strongly recommended to ensure the safety of both the mother and the fetus.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes this medication.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a history of liver disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment. Careful evaluation is necessary to ensure safe and effective use in this population.

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 are advised to remain vigilant for any potential symptoms that may arise following an overdose. The absence of symptoms does not preclude the possibility of serious complications, and therefore, monitoring and evaluation should be conducted as a precautionary measure.

Management of an overdose should be guided by clinical judgment and may involve supportive care, symptomatic treatment, and specific interventions as indicated. It is crucial to follow established protocols and guidelines to ensure the safety and well-being of the patient.

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 immediately and seek medical assistance.

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 crucial even if no signs or symptoms are apparent.

Patients should be informed not to use 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 are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised 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 must be cautioned against exceeding the recommended dose, as this could lead to overdose. Furthermore, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease. Lastly, patients should be advised to speak with a doctor or pharmacist prior to use 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. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability 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 integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, it is crucial for patients to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential even if no signs or symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Foster and Thrive 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 Foster and Thrive 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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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.