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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 1995
Label revision date
May 7, 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 1995
Label revision date
May 7, 2024
Manufacturer
Walgreen Company
Registration number
M013
NDC root
0363-0212
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Acetaminophen is a medication commonly used to relieve minor aches and pains, as well as to reduce fever in children aged 2 to 11 years. It comes in an oral suspension form, specifically designed for easy dosing, and is available in a pleasant grape flavor. This medication is aspirin-free, alcohol-free, ibuprofen-free, and paraben-free, making it a suitable option for young children.

Acetaminophen works by reducing fever and alleviating discomfort associated with common conditions such as the cold, flu, headaches, sore throats, and toothaches. It is comparable to the active ingredient found in Children’s Tylenol® Oral Suspension and is often recommended by pharmacists for its effectiveness and safety profile.

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 safe in terms of teratogenic effects, meaning it does not cause birth defects. If you have any questions about how this medication can help you, feel free to ask your healthcare provider.

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 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. As the weight increases, so does the dose: 7.5 mL for 36-47 pounds (ages 4-5 years), 10 mL for 48-59 pounds (ages 6-8 years), 12.5 mL for 60-71 pounds (ages 9-10 years), and 15 mL for children weighing 72-95 pounds (age 11 years).

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’s symptoms persist, 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. 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 product if your child has ever had an allergic reaction to it or any of its ingredients. Additionally, do not combine it with any other medications 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.

Always follow the recommended dosage and never exceed it, as doing so can lead to serious health risks. Keeping these guidelines in mind will help ensure the safe use of this product.

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 products 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. Other reasons to stop use and contact a doctor include worsening pain or fever lasting more than 3 days, new symptoms, or any redness or swelling, as these could indicate a serious condition. Always check with a doctor if your child has liver disease or is taking blood thinners like warfarin before using this medication.

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 thinner 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 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 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 be cautious with any medications, including acetaminophen. Currently, there is no specific information available about the safety of using acetaminophen during pregnancy, which means that there are no established guidelines regarding its use, dosage adjustments, or any special precautions you should take.

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

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 substances could affect you or your baby.

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

Pediatric Use

When giving this medication to your child, it's important to follow the correct dosage 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 3 years and weighing between 24 to 35 pounds, the dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4 to 5 years (36-47 pounds), 10 mL for ages 6 to 8 years (48-59 pounds), 12.5 mL for ages 9 to 10 years (60-71 pounds), and 15 mL for 11-year-olds (72-95 pounds).

Make sure to keep this medication out of reach of children and never use it if your child has had an allergic reaction to it or any of its ingredients. If your child has liver disease or is taking the blood thinner warfarin, consult a doctor or pharmacist before use. Always use the dosing cup provided with the product, and in case of an overdose, seek medical help immediately, even if there are no noticeable symptoms.

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 a healthcare professional before using it.

Always prioritize safety and ensure that any medication or treatment is appropriate for your individual health needs, especially as you may have different considerations compared to younger adults.

Renal Impairment

If your child has liver disease, it's important to consult with a doctor before using this medication. This ensures that any potential risks are properly assessed and managed. Always prioritize your child's health by seeking professional guidance when it comes to their treatment options.

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 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.

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 needed, but do not exceed 5 doses in a 24-hour period. If your child has liver disease, or is taking the blood thinner warfarin, consult a doctor or pharmacist before use.

If your child's pain worsens or lasts more than 5 days, if a fever worsens or lasts more than 3 days, or if new symptoms arise, stop using the medication and seek medical advice. Additionally, watch for any signs of redness or swelling.

FAQ

What is Acetaminophen used for?

Acetaminophen 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?

The 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.

How often can I give Acetaminophen to my child?

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

Are there any warnings associated with Acetaminophen?

Yes, severe liver damage may occur if your child takes more than 5 doses in 24 hours or with other drugs containing acetaminophen. Additionally, it may cause severe skin reactions.

Can I use Acetaminophen if my child has allergies?

Do not use Acetaminophen if your child has ever had an allergic reaction to this product or any of its ingredients.

Is Acetaminophen safe during pregnancy?

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

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.

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

Stop use and ask a doctor if pain lasts more than 5 days or fever lasts more than 3 days, or if new symptoms occur.

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 an oral suspension formulated to provide pain relief and reduce fever, containing 160 mg of acetaminophen per 5 mL. This preparation is specifically designed for pediatric use in children aged 2 to 11 years. The product is presented in a 4 fl oz (118 mL) bottle and features a grape flavor for palatability. It is free from aspirin, alcohol, ibuprofen, and parabens, making it suitable for sensitive populations.

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 does not contain directions or complete warnings for adult use. Healthcare professionals should advise caregivers to adhere strictly to the dosing guidelines provided, ensuring that no more than the recommended dose is administered to avoid the risk of overdose.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosing chart below, with weight being the preferred method for dosing. If weight is not available, age may be used as an alternative.

To administer the dose, caregivers should remove the child protective cap and squeeze the prescribed amount into the enclosed dosing cup, which is specifically designed for use with this product. The dose may be repeated every 4 hours as needed while symptoms persist, but it is imperative that no more than 5 doses are given within a 24-hour period.

Dosage Chart:

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

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

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

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

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

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

Dosing should always be conducted using the enclosed dosing cup, and no other dosing devices should be utilized.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

  • This product should not be administered to children who have a history of allergic reactions to this product or any of its components, as this may lead to severe allergic responses.

  • Exceeding the recommended dosage is contraindicated, as it poses a risk of 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 also 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 is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional without delay.

Healthcare providers should inquire about the presence of liver disease before recommending this product for children. Additionally, it is advisable 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 for guidance, even if no symptoms are apparent.

Patients should 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 if more than 5 doses of the product are taken within a 24-hour period, which is the maximum daily amount. Additionally, the risk of severe liver damage increases if this product is used concurrently with other medications containing acetaminophen.

Patients 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 medical assistance immediately.

A warning regarding sore throat is also pertinent; if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Patients are advised to stop use and consult a doctor if pain worsens or lasts longer than 5 days, if fever worsens or persists for more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients consult a doctor prior to use if they have liver disease. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before using this product.

Drug Interactions

The concomitant use of this medication with warfarin, a blood-thinning agent, requires caution. It is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating treatment if they are currently prescribed warfarin. This interaction may necessitate careful monitoring of coagulation parameters to ensure patient safety and efficacy of therapy.

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 this product with specific dosing based on weight. The recommended doses are as follows: for patients under 24 lb (under 2 years), consultation with a doctor is advised; for those weighing 24-35 lb (2-3 years), the dose is 5 mL; for 36-47 lb (4-5 years), the dose is 7.5 mL; for 48-59 lb (6-8 years), the dose is 10 mL; for 60-71 lb (9-10 years), the dose is 12.5 mL; and for those weighing 72-95 lb (11 years), the dose is 15 mL.

It is crucial to avoid use in children who have a history of allergic reactions to this product or any of its ingredients. Prior to administration, consultation with a healthcare professional is recommended if the child has liver disease or is taking the blood-thinning medication warfarin.

Parents and caregivers should ensure that the product is kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is essential even if no symptoms are observed.

For accurate dosing, only the enclosed dosing cup specifically designed for this product should be used; other dosing devices are not recommended.

Geriatric Use

Elderly patients may not receive comprehensive directions or warnings regarding the use of this product. Therefore, healthcare providers should exercise caution when prescribing this product to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect the safety and efficacy of the treatment in this population.

Healthcare providers are advised to closely monitor elderly patients for any adverse effects and to adjust dosages as necessary based on individual patient needs and responses. Given the lack of specific guidance for adult use, careful evaluation and clinical judgment are paramount when managing treatment in geriatric patients.

Pregnancy

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

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 evaluate 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 assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful evaluation and ongoing monitoring may be necessary to ensure the safe and effective use of the medication in this 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 the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals should be aware that quick medical attention is critical in managing overdose situations. Even in cases where patients may not exhibit any immediate symptoms, the risk of delayed effects necessitates thorough evaluation and monitoring. It is advisable to follow established protocols for overdose management, which may include supportive care and symptomatic treatment as indicated.

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 understanding of potential risks associated with the compound in nonclinical settings.

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 for more than five days, if fever intensifies or lasts longer 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 using this product 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 compromised integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

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 prior to use if the child has liver disease or is concurrently taking warfarin, a blood-thinning medication. Patients should be instructed to 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.

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.