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Childrens Acetaminophen Oral Suspension

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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
October 21, 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
October 21, 2024
Manufacturer
American Health Packaging
Registration number
M013
NDC root
60687-762
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 is an oral suspension medication that contains 160 mg of acetaminophen per 5 mL. It is primarily used to reduce fever and relieve minor aches and pains associated with common conditions such as the cold, flu, headache, sore throat, and toothache. This medication is dye-free and comes in a pleasant grape flavor, making it easier for children to take.

As a pain reliever and fever reducer, Children’s Acetaminophen is a safe option that is free from ibuprofen, alcohol, and aspirin. Always ensure to shake the bottle well before use to mix the medication properly.

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. You can feel confident using it for the relief of your symptoms.

Dosage and Administration

Before using this product, make sure to shake the bottle well. It's important to follow the dosage instructions carefully. You can find the right dose based on your child's weight or age. If your child weighs less than 24 pounds and is under 2 years old, you should consult a doctor for the appropriate dosage. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 5 mL, which is equivalent to one unit dose cup.

For children aged 4 to 5 years weighing between 36 and 47 pounds, the dose increases to 7.5 mL (1.5 unit dose cups). If your child is 6 to 8 years old and weighs between 48 and 59 pounds, the dose is 10 mL (2 unit dose cups). For those aged 9 to 10 years weighing between 60 and 71 pounds, the dose is 12.5 mL (2.5 unit dose cups). Finally, for an 11-year-old weighing between 72 and 95 pounds, the dose is 15 mL (3 unit dose cups).

You can repeat the dose every 4 hours as long as symptoms persist, but remember not to exceed 5 doses in a 24-hour period. Always be cautious and do not take more than directed, as there is an overdose warning associated with this product.

What to Avoid

It's important to be cautious when using this medication. You should not use it alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this product if your child is allergic to acetaminophen or any of its inactive ingredients.

Always follow the recommended dosage and avoid exceeding it, as doing so can lead to serious health risks. If you have any questions or concerns about using this medication, don't hesitate to reach out to a healthcare professional for guidance.

Side Effects

You should be aware of some important warnings and potential side effects when using this product. It 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, there is a risk of serious skin reactions, such as skin reddening, blisters, or rash. If any of these symptoms occur, 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 also crucial to seek medical attention in case of an overdose, even if no symptoms are present. You should stop using the product and consult a 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. Always consult a doctor before use if your child has liver disease or is taking the blood thinner warfarin.

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 that also contain acetaminophen. It's important to be aware of potential severe 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 sore throat that is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away. Additionally, you should 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. Always consult a doctor before use if your child has liver disease or is taking the blood-thinning medication warfarin.

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. Quick action is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but it’s essential to be vigilant and act quickly. If you notice unusual behavior or physical symptoms, don’t hesitate to reach out for help. Remember, getting prompt medical attention can make a significant difference.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety, dosage adjustments, 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 this product. They can help you understand any potential risks and make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications or treatments during this important time.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When it comes to giving this medication to children, it's important to follow specific guidelines based on their age and weight. For children under 2 years old who weigh less than 24 pounds, you should consult a doctor before administering the medication. For those aged 2 to 3 years and weighing between 24 to 35 pounds, the recommended dose is 5 mL, which is equivalent to one unit dose cup.

As your child grows, the dosage increases: for ages 4 to 5 years (36 to 47 pounds), the dose is 7.5 mL (1.5 unit dose cups); for ages 6 to 8 years (48 to 59 pounds), it's 10 mL (2 unit dose cups); for ages 9 to 10 years (60 to 71 pounds), it's 12.5 mL (2.5 unit dose cups); and for 11-year-olds weighing 72 to 95 pounds, the dose is 15 mL (3 unit dose cups). Always follow your doctor’s instructions if they provide a different dosage.

Geriatric Use

When it comes to using Children's Acetaminophen Oral Suspension for older adults, there is no specific information available in the drug insert. This means that if you are caring for an older adult, it's important to consult with a healthcare professional before administering this medication. They can provide guidance tailored to individual health needs and any potential concerns.

Always ensure that any medication is appropriate for the older adult's overall health, especially if they have existing conditions or are taking other medications. Your healthcare provider can help you understand the best options for pain relief or fever management in older adults.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any treatment you receive is safe and effective based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to be cautious with medications that contain acetaminophen. Taking more than 5 doses in a 24-hour period can lead to severe liver damage, which is a serious concern. This maximum daily amount should not be exceeded, and you should also avoid using other medications that contain acetaminophen at the same time.

Always consult with your healthcare provider about the safest options for managing your symptoms, especially if you have a history of liver issues. They can help you determine the right dosage and monitor your liver function to ensure your safety.

Drug Interactions

It's important to talk to your healthcare provider 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 with a doctor or pharmacist first.

Additionally, you should avoid using this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, don't hesitate to ask your healthcare provider for guidance. Keeping open communication about all medications helps ensure your safety and well-being.

Storage and Handling

To ensure the best results with your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). Before using, make sure to shake the product well to mix its contents thoroughly. It's important to check the seal; do not use the product if the seal is broken, as this could compromise its safety and effectiveness.

By following these simple storage and handling guidelines, you can help maintain the quality and safety of the product.

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.

Before giving this medication to your child, consult a doctor if they have liver disease or are 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 use and seek medical advice. Additionally, contact a doctor if new symptoms appear or if there is any redness or swelling.

FAQ

What is Children's Acetaminophen used for?

Children's Acetaminophen 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 store Children's Acetaminophen?

Store Children's Acetaminophen at 20° to 25°C (68° to 77°F).

What should I do before using Children's Acetaminophen?

Shake well before using and consult a doctor if your child has liver disease or is taking the blood thinning drug warfarin.

What is the usual dosage for Children's Acetaminophen?

The usual dosage varies by weight and age. For example, children aged 2-3 years weighing 24-35 lbs should take 5 mL.

What are the warnings associated with Children's Acetaminophen?

Do not exceed 5 doses in 24 hours, and do not use 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 experiences skin reddening, blisters, or rash, stop use and seek medical help immediately.

Can I give Children's Acetaminophen to my child if they are allergic to acetaminophen?

No, do not use Children's Acetaminophen if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

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

If pain lasts more than 5 days or fever lasts more than 3 days, or if new symptoms occur, stop use and consult a doctor.

Packaging Info

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

Packaging configurations for Childrens Acetaminophen Oral Suspension.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children’s Acetaminophen is an oral suspension formulated to provide effective pain relief and fever reduction. Each 5 mL dose contains 160 mg of acetaminophen. The product is dye-free and features a grape flavor, making it suitable for pediatric use. It is free from ibuprofen, alcohol, and aspirin, ensuring a safer option for children. This formulation is intended for institutional use only and should be stored at a temperature range of 20° to 25°C (68° to 77°F).

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

Dosing should be repeated every 4 hours as needed while symptoms persist, with a maximum of 5 doses administered within a 24-hour period. It is critical not to exceed the recommended dosage.

Dosage Chart:

  • For patients weighing under 24 lb (under 2 years of age), the dose should be determined by consulting a physician.

  • For patients weighing 24-35 lb (2-3 years of age), the recommended dose is 5 mL (1 unit dose cup).

  • For patients weighing 36-47 lb (4-5 years of age), the recommended dose is 7.5 mL (1.5 unit dose cups).

  • For patients weighing 48-59 lb (6-8 years of age), the recommended dose is 10 mL (2 unit dose cups).

  • For patients weighing 60-71 lb (9-10 years of age), the recommended dose is 12.5 mL (2.5 unit dose cups).

  • For patients weighing 72-95 lb (11 years of age), the recommended dose is 15 mL (3 unit dose cups).

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

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

  • This product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

  • Exceeding the recommended dosage while using this product is contraindicated due to the risk of overdose.

Warnings and Precautions

Severe liver damage may occur in pediatric patients taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they concurrently use other medications containing acetaminophen. Healthcare professionals should monitor for signs of liver impairment and educate caregivers on the importance of adhering to dosing guidelines.

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. Healthcare providers should be vigilant in assessing patients for these symptoms and advising caregivers accordingly.

In cases of severe sore throat that persists for more than 2 days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended. This may indicate a more serious underlying condition that requires further evaluation.

Patients should be advised to discontinue use and consult a healthcare professional if pain worsens or lasts longer than 5 days, if fever intensifies or persists beyond 3 days, if new symptoms arise, or if there is any redness or swelling. These signs may indicate a serious medical condition that necessitates further investigation.

Prior to administration, it is essential to inquire about any existing liver disease in the patient, as this may contraindicate the use of acetaminophen. Additionally, healthcare providers should advise caregivers to consult with a physician or pharmacist if the child is currently taking warfarin or any other anticoagulant, as potential interactions may require careful management.

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. It is crucial for patients to adhere to the recommended dosage to avoid serious liver injury.

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. If any of these symptoms occur, patients should discontinue use immediately and seek medical assistance.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

In the event of an overdose, it is imperative to seek medical help or contact a Poison Control Center immediately, as timely medical intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to stop using the product and consult a doctor 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 redness or swelling is observed, as these may indicate a serious condition.

Furthermore, it is recommended that patients consult a healthcare provider before using this product if they have liver disease or if they are taking the blood-thinning medication warfarin.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose may be heightened, leading to serious hepatic complications. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

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

Packaging configurations for Childrens Acetaminophen Oral Suspension.
Details

Pediatric Use

Pediatric patients under 2 years of age should be advised to consult a healthcare professional before use. For children aged 2 to 3 years, the recommended dosage is 5 mL (1 unit dose cup) for those weighing between 24-35 pounds. For children aged 4 to 5 years, the dosage increases to 7.5 mL (1.5 unit dose cups) for those weighing 36-47 pounds.

In children aged 6 to 8 years, the recommended dosage is 10 mL (2 unit dose cups) for those weighing 48-59 pounds. For those aged 9 to 10 years, the dosage is 12.5 mL (2.5 unit dose cups) for weights of 60-71 pounds. Finally, for children aged 11 years, the recommended dosage is 15 mL (3 unit dose cups) for those weighing 72-95 pounds. Dosage may also be adjusted as directed by a healthcare professional.

Geriatric Use

Elderly patients may not have specific information regarding the use of Children's Acetaminophen Oral Suspension. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the lack of clinical data specifically addressing the geriatric population, it is advisable to monitor elderly patients closely for any adverse effects or changes in efficacy. Additionally, healthcare providers should consider potential age-related physiological changes that may affect drug metabolism and clearance when determining appropriate dosing for this demographic.

In the absence of established guidelines, individualized treatment plans should be developed, taking into account the overall health status and comorbidities of elderly patients.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy, including safety concerns, dosage modifications, or special precautions. Therefore, healthcare professionals are advised to exercise caution when prescribing this product to pregnant patients. The potential risks and benefits should be carefully considered, and alternative therapies may be warranted based on individual patient circumstances. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity. Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen, as this may further increase the risk of liver injury. Regular assessment of liver function may be warranted in patients with compromised liver health to ensure safety and efficacy of treatment.

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 medical intervention is crucial for both adults and children, 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 health consequences. Therefore, it is essential to monitor the patient closely and provide supportive care as necessary.

In managing an overdose, the healthcare provider should assess the patient's condition and consider the need for further diagnostic evaluation and treatment based on the specific substance involved and the clinical presentation.

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 to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if any of the following occur: if pain worsens or persists for more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms develop, or if there is any redness or swelling. These symptoms may indicate a serious condition that requires further evaluation.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with exceeding this dosage, as outlined in the overdose warning. Additionally, 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 a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy and stability.

Prior to use, the product must be shaken well to ensure proper mixing of its components. Additionally, it is imperative to inspect the seal before use; the product should not be utilized if the seal is broken, as this may compromise its integrity and safety.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist, not to exceed 5 doses within a 24-hour period. Clinicians should counsel patients to consult a doctor before use 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 5 days, if fever intensifies or lasts more than 3 days, or if new symptoms arise, including redness or swelling.

Drug Information (PDF)

This file contains official product information for Childrens Acetaminophen Oral Suspension, 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 Oral Suspension, 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.