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Childrens Acetaminophen

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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 2007
Label revision date
October 8, 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 2007
Label revision date
October 8, 2024
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Registration number
M013
NDC root
0121-1781
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 Acetaminophen Oral Suspension is a liquid medication designed to help relieve minor aches and pains in children, such as those caused by the common cold, flu, headaches, sore throats, and toothaches. It also works to reduce fever, making it a useful option for parents looking to comfort their children during illness.

This formulation delivers 160 mg of acetaminophen (a common pain reliever and fever reducer) in every 5 mL dose. It is important to note that this product is free from ibuprofen, alcohol, and aspirin, making it a gentle choice for young ones.

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 unwell, making it easier to manage everyday discomforts.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. To ensure safety, make sure you do not exceed the recommended dosage. Always shake the bottle well before using it.

To find the right dose, refer to the dosage chart based on weight or age. If possible, use weight for a more accurate dose. For example, if your child weighs between 24-35 pounds and is 2-3 years old, the dose would be 5 mL. You can repeat the dose every 4 hours as long as symptoms persist, but remember not to give more than 5 doses in a 24-hour period. Always consult a doctor if your child is under 24 pounds or under 2 years old.

What to Avoid

It's important to keep this medication out of the reach of children to ensure their safety. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow any additional guidance provided by your healthcare professional.

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. Be aware that acetaminophen may also 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.

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. It's important not to use this product with any other acetaminophen-containing medications and to check with a healthcare professional if your child has liver disease or is taking the blood thinner warfarin. If pain or fever worsens or lasts longer than the specified time, or if new symptoms arise, stop use and contact a doctor, as these may 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 redness, blisters, or rashes. If you notice any of these symptoms, 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 right away. Avoid using this product if your child is allergic to acetaminophen or any of its inactive ingredients, and check with a doctor if your child has liver disease or is taking the blood thinner warfarin. Always follow the recommended dosage and stop use if pain or fever worsens or lasts longer than specified, or if new symptoms arise.

In case of an overdose, it’s crucial to get medical help or contact a Poison Control Center immediately at 1-800-222-1222, even if there are no noticeable symptoms. Quick action is important for both adults and children.

Overdose

It's important to follow the recommended dose of this product carefully. Taking more than the suggested amount can lead to an overdose, which may cause serious health issues. Signs of an overdose can include symptoms like extreme drowsiness, confusion, or difficulty breathing (respiratory depression).

If you suspect an overdose has occurred, seek immediate medical help. It's crucial to act quickly, as timely intervention can make a significant difference in your recovery. Always remember, when in doubt, it's better to consult a healthcare professional.

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 established. Before using this medication, you should consult your doctor to discuss any potential risks to your fetus, as these are not clearly defined.

There are no specific dosage modifications recommended for pregnant individuals, so it's essential to seek guidance from a healthcare professional regarding the appropriate use of acetaminophen. Always weigh the potential benefits against the risks with your provider to make an informed decision about your health and the health of your baby.

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 be passed into your breast milk, which means it could affect your baby. Since the effects on nursing infants have not been thoroughly studied, it’s best to exercise caution. Always prioritize your health and your baby's well-being by seeking professional advice.

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 recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4 to 5 years (36-47 lbs), 10 mL for ages 6 to 8 years (48-59 lbs), 12.5 mL for ages 9 to 10 years (60-71 lbs), and 15 mL for 11-year-olds (72-95 lbs). Always follow your doctor’s instructions if they provide a different dosage.

Be aware that this medication contains acetaminophen, which can cause severe liver damage if your child takes more than 5 doses in 24 hours or uses it with other acetaminophen-containing products. Additionally, watch for any signs of severe skin reactions, such as redness, blisters, or rash, and seek medical help immediately if they occur. If your child has liver disease or is taking the blood thinner warfarin, consult a doctor before use. Always keep this medication out of reach of children, and in case of overdose, seek medical help or contact a Poison Control Center right away, even if no symptoms are present.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person’s health needs can vary. Since the insert does not mention any age-related dosage adjustments, safety concerns, or special precautions for elderly patients, you should still consult with a healthcare provider. They can help determine the best approach for you or your loved one, taking into account any unique health conditions or medications that may be involved. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 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 of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This range is considered a controlled room temperature according to the United States Pharmacopeia (USP). It's important to keep the product protected from freezing, as extreme cold can damage it.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them to ensure safety and compliance.

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. If your child has liver disease or is taking the blood-thinning medication warfarin, consult a doctor or pharmacist before use.

It's important to stop using the medication and seek medical advice if your child's pain worsens or lasts more than 5 days, if a fever worsens or lasts more than 3 days, if new symptoms develop, or if there is any redness or swelling.

FAQ

What is Children's Acetaminophen Oral Suspension used for?

Children's Acetaminophen Oral Suspension is used to reduce fever and relieve minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

How should I administer Children's Acetaminophen Oral Suspension?

Shake well before using and follow the dosage chart based on your child's weight or age. Do not exceed 5 doses in 24 hours.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately. Quick medical attention is critical.

Are there any warnings associated with this product?

Yes, it contains acetaminophen, which can cause severe liver damage if taken in excess. It may also cause severe skin reactions; stop use and seek medical help if symptoms occur.

Is it safe to use Children's Acetaminophen during pregnancy?

The safety of acetaminophen during pregnancy has not been established. Consult a healthcare provider before use.

Can nursing mothers use this product?

Nursing mothers should consult a doctor before using this product, as there is potential for excretion in breast milk.

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

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.

What are the storage instructions for this product?

Store at 20° to 25°C (68° to 77°F) and protect from freezing.

Packaging Info

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

Packaging configurations for Childrens Acetaminophen.
Details

Drug Information (PDF)

This file contains official product information for Childrens Acetaminophen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

CHILDREN'S ACETAMINOPHEN ORAL SUSPENSION is an oral suspension formulation with a strength of 160 mg of acetaminophen per 5 mL. This product is characterized as ibuprofen-free, alcohol-free, and aspirin-free. It is manufactured by Pharmaceutical Associates, Inc., located in Greenville, SC 29605. The packaging is not child-resistant, and it is advised to shake well before use. The National Drug Code (NDC) for this product is 0121-1781-05.

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 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 to ensure proper mixing.

The recommended dosing intervals are every 4 hours as needed while symptoms persist. However, it is crucial not to exceed 5 doses within a 24-hour period.

Dosage Chart:

  • For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a doctor for appropriate dosing.

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

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

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

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

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

Healthcare professionals should ensure that patients do not exceed the maximum dosage and should monitor for any signs of overdose.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of the reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the maximum daily dosage of 5 doses within 24 hours is exceeded or if it is taken concurrently with other medications containing acetaminophen. Healthcare professionals should advise patients to strictly adhere to the recommended dosing guidelines to mitigate the risk of liver injury.

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, patients should be instructed to consult a physician without delay.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be advised to consult a healthcare professional. Additionally, this product is contraindicated in individuals with a known allergy to acetaminophen or any of its inactive ingredients.

Healthcare providers should inquire about the patient's medical history, particularly regarding liver disease, before recommending this product. Furthermore, caution is advised for patients who are concurrently taking the anticoagulant warfarin; consultation with a doctor or pharmacist is recommended prior to use.

Patients must be reminded not to exceed the recommended dosage, as doing so poses a risk of overdose. Signs that warrant discontinuation of the product and consultation with a healthcare provider include worsening pain lasting more than 5 days, fever persisting beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent. The national Poison Control Center can be reached at 1-800-222-1222.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if a child exceeds five doses within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen. Patients should be aware of the potential for severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek immediate medical assistance.

Additionally, a warning is issued for severe 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, patients should consult a healthcare professional promptly.

The product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to consult a doctor or pharmacist. The product is contraindicated in children with known allergies to acetaminophen or any inactive ingredients contained within.

Before using this product, it is recommended that patients consult a healthcare provider if the child has liver disease or is taking the anticoagulant warfarin.

Patients should discontinue use and seek medical advice if pain worsens or persists beyond five days, if fever worsens or lasts more than three days, if new symptoms arise, or if redness or swelling occurs, 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 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 and associated hepatotoxicity may be heightened. 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 Acetaminophen (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Acetaminophen.
Details

Pediatric Use

Pediatric patients require careful consideration when using this product. Dosing is weight- and age-dependent, as follows: for children under 24 lbs and under 2 years, consultation with a doctor is advised; for those weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL; for 36-47 lbs (4-5 years), 7.5 mL; for 48-59 lbs (6-8 years), 10 mL; for 60-71 lbs (9-10 years), 12.5 mL; and for 72-95 lbs (11 years), 15 mL, or as directed by a physician.

Caution is warranted due to the presence of acetaminophen, which can lead to severe liver damage if more than 5 doses are taken within 24 hours or if used concurrently with other acetaminophen-containing medications. Additionally, acetaminophen may cause severe skin reactions, including skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance sought.

Parents and caregivers should be aware of specific warnings: if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly. Prior to use, it is essential to consult a healthcare professional if the child has liver disease or is taking the blood-thinning medication warfarin.

This product should be kept out of the reach of children. In the event of an overdose, immediate medical help or contact with a Poison Control Center is critical, even if no symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for this population. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential comorbidities. Regular monitoring may be warranted to ensure safety and efficacy in this demographic.

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. There are no specific dosage modifications for pregnant individuals; therefore, it is essential to seek guidance from a healthcare provider regarding appropriate use. The decision to use acetaminophen during pregnancy should involve a discussion with a healthcare provider to carefully weigh the potential benefits against the risks.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 renal function and consider potential dosing adjustments or monitoring requirements based on the patient's overall health status.

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. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

Overdosage

Exceeding the recommended dose of this product may lead to serious health consequences. Healthcare professionals are advised to closely monitor patients for any signs of overdosage, as the effects can vary based on individual patient factors.

Recommended Actions In the event of suspected overdosage, immediate medical attention should be sought. It is crucial to assess the patient's condition and provide supportive care as necessary. Healthcare providers should refer to established protocols for managing drug overdosage, which may include symptomatic treatment and monitoring of vital signs.

Potential Symptoms Patients experiencing overdosage may present with a range of symptoms, which can include but are not limited to: insert specific symptoms if available. The severity of symptoms may depend on the extent of the overdose and the patient's overall health status.

Management Procedures Management of overdosage should be tailored to the individual patient. Healthcare professionals should consider the use of activated charcoal if the patient presents within a suitable timeframe and is alert. Continuous monitoring and supportive care are essential to address any complications that may arise from the overdosage.

In summary, adherence to the recommended dosing guidelines is critical to prevent overdosage and its associated risks.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or 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 keep the medication out of the reach of children to prevent accidental ingestion.

In the event of an overdose, it is crucial for patients to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Healthcare providers should emphasize that quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Storage and Handling

The product is supplied in accordance with the following specifications. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in compliance with USP Controlled Room Temperature guidelines. It is essential to protect the product from freezing to maintain its integrity and efficacy.

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 intensifies 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 Acetaminophen, 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 Acetaminophen, 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.