Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Acetaminophen

Last content change checked dailysee data sync status

Active ingredient
Acetaminophen 160 mg
Other brand names
Dosage form
Tablet, Chewable
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
July 17, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg
Other brand names
Dosage form
Tablet, Chewable
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
July 17, 2023
Manufacturer
Allegiant Health
Registration number
M013
NDC root
69168-440
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

This medication is a children's chewable tablet designed to temporarily relieve minor aches and pains, such as those caused by headaches, sore throats, flu, toothaches, and the common cold. Additionally, it helps to reduce fever, making it a useful option for managing discomfort during illness. Effective as of July 17, 2023, this medication aims to provide relief for your child when they are feeling unwell.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, sore throats, flu, toothaches, and the common cold. Additionally, it helps to temporarily reduce fever, making you feel more comfortable when you're not feeling well.

Rest assured, there are no teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

When using this medication, it's important to follow the dosage instructions carefully. First, check the dosage chart to find the right amount for you or your child based on weight or age. If your child weighs under 24 pounds or is under 2 years old, consult a doctor for guidance. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 1 chewable tablet. As the weight increases, so does the dosage, with 1.5 tablets for ages 4 to 5 years (36-47 pounds), 2 tablets for ages 6 to 8 years (48-59 pounds), 2.5 tablets for ages 9 to 10 years (60-71 pounds), and 3 tablets for an 11-year-old (72-95 pounds).

Make sure to chew the tablet before swallowing, as it will soften in your mouth to make chewing easier. You can repeat the dose every 4 hours as long as symptoms persist, but do not exceed 5 doses in a 24-hour period. Additionally, do not use this medication for more than 5 days unless your doctor advises you to do so. Always remember to stick to the recommended amounts to ensure safety and effectiveness.

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 includes acetaminophen, please consult your doctor or pharmacist for clarification.

Additionally, if your child has a known allergy to acetaminophen or any of the inactive ingredients in this product, do not use it. Always prioritize safety and seek professional advice if you have any questions or concerns.

Side Effects

You should be aware that this product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Additionally, 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.

It's important to consult a doctor if your child's sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. You should also stop use and contact 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, as these could indicate a serious condition. Always check with a doctor before use if your child has liver disease or is taking the blood thinner warfarin.

Warnings and Precautions

It's important to be aware of some key warnings when using this product, which contains acetaminophen. Taking more than 5 doses in 24 hours can lead to severe liver damage, especially if combined with other medications that also contain acetaminophen. Additionally, be cautious 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 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 wise to check with 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 no symptoms are present, as prompt attention is crucial. If your child's pain worsens or lasts more than 5 days, or if a fever persists for more than 3 days, stop using the product and call your doctor, as these could indicate a more serious issue.

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. This 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 they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety or potential risks to you or your developing baby. The insert does not indicate whether the product is contraindicated (not recommended) for pregnant individuals, nor does it mention any necessary dosage changes or special precautions for use during this time.

As always, it's important to consult with your healthcare provider before using any medication or product while pregnant to ensure the best care for you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no guidelines or data provided, you may want to consult your healthcare provider for personalized advice if you are breastfeeding or planning to breastfeed. They can help you understand any potential risks and make informed decisions for you and your baby.

Pediatric Use

When giving medication to your child, it's important to follow the recommended dosages based on their weight and age. For children under 2 years old who weigh less than 24 pounds, you should consult a doctor before administering any medication. For those aged 2 to 3 years and weighing between 24 to 35 pounds, the dose is 1 tablet. As your child grows, the dosage increases: 1.5 tablets for ages 4 to 5 years (36-47 pounds), 2 tablets for ages 6 to 8 years (48-59 pounds), 2.5 tablets for ages 9 to 10 years (60-71 pounds), and 3 tablets for an 11-year-old (72-95 pounds). Always use weight for dosing when possible, and do not exceed 5 doses in a 24-hour period or use the medication for more than 5 days without a doctor's guidance.

Be aware of safety concerns when giving this medication. Never exceed the recommended dosage, as doing so can lead to severe liver damage, especially if your child is also taking other medications containing acetaminophen. Watch for any signs of severe skin reactions, such as redness, blisters, or rashes, and seek medical help immediately if they occur. If your child has a severe sore throat that lasts more than 2 days or is accompanied by other symptoms like fever or nausea, consult a doctor. Always check with a healthcare professional if your child has liver disease or is taking blood thinners like warfarin. In case of an overdose, contact a Poison Control Center or seek medical help right away, even if there are no immediate symptoms.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since the insert mainly discusses pediatric use, you should consult your healthcare provider for personalized advice, especially if you or a loved one is an older adult. They can help determine if any dosage adjustments or special precautions are necessary based on individual health needs.

Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a healthcare professional is essential for ensuring safety and effectiveness.

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 managed and that the treatment is safe for your child's specific health needs. Always prioritize open communication with your healthcare provider regarding any existing health conditions.

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 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. 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 at room temperature, specifically at 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F) if necessary. Always check the packaging before use; do not use the product if the safety seal under the cap is broken or missing, as this indicates that the product may have been tampered with and could be unsafe.

By following these simple storage and handling guidelines, you can help maintain the product's integrity and ensure your safety.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as your symptoms persist. However, do not exceed 5 doses in a 24-hour period, and avoid using it for more than 5 days unless your doctor advises otherwise. Always follow your healthcare provider's instructions for safe use.

FAQ

What is the general description of this medication?

This medication is a children's chewable tablet.

What symptoms does this medication temporarily relieve?

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

What should I do if my child is under 24 lb?

If your child is under 24 lb (under 2 years), you should ask a doctor before use.

How often can I give this medication?

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

What are the dosing recommendations for children aged 2 to 11 years?

For children aged 2-3 years, give 1 tablet; 4-5 years, 1 1/2 tablets; 6-8 years, 2 tablets; 9-10 years, 2 1/2 tablets; and 11 years, 3 tablets.

What should I do if my child has a severe sore throat?

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 warnings associated with this medication?

This medication contains acetaminophen, which can cause severe liver damage if more than 5 doses are taken in 24 hours or if used with other acetaminophen-containing drugs.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Can this medication be used with other drugs containing acetaminophen?

No, do not use this medication with any other drug containing acetaminophen, whether prescription or nonprescription.

Is there any information regarding use during pregnancy?

There is no specific information provided regarding the use of this medication during pregnancy.

What should I do if my child has liver disease?

Ask a doctor before use if your child has liver disease.

Packaging Info

Below are the non-prescription pack sizes of Children Pain Relief. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Children Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Chewable Tablet is a dosage form designed for pediatric use. This formulation allows for easy administration and palatability, catering to the needs of children. The tablet is specifically designed to be chewed, facilitating the absorption of the active ingredients.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, sore throat, flu, toothache, and the common cold. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The recommended dosage of this product should not exceed the specified limits. Healthcare professionals are advised to determine the appropriate dose based on the patient's weight; if weight is not available, age may be used as a guide.

Patients should chew the tablets thoroughly before swallowing, as the formulation is designed to soften in the mouth to facilitate easier chewing. Dosing may be repeated every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period. Treatment should not extend beyond 5 consecutive days unless directed by a physician.

The following dosage chart provides specific dosing recommendations:

  • For patients weighing under 24 lb or under 2 years of age, consultation with a doctor is required.

  • For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 1 chewable tablet.

  • For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 1 ½ chewable tablets.

  • For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 2 chewable tablets.

  • For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 2 ½ chewable tablets.

  • For patients weighing 72-95 lb or aged 11 years, the recommended dose is 3 chewable tablets.

Dosing may also be adjusted as directed by a healthcare professional.

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.

Additionally, this product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise caregivers that exceeding five doses within a 24-hour period, which is the maximum daily amount, or administering this product concurrently with other medications containing acetaminophen can significantly increase the risk of liver injury.

Acetaminophen may also provoke severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and 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 two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is essential.

Healthcare professionals should exercise caution and recommend that caregivers consult a physician prior to use if the child has a history of liver disease. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Caregivers should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

Caregivers should be advised to discontinue use and consult a healthcare provider if the child experiences worsening pain lasting more than five days, fever that worsens or persists beyond three days, the emergence of new symptoms, or any signs of redness or swelling, as these may indicate a serious underlying condition.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if it is taken concurrently with other medications containing acetaminophen. Patients with pre-existing liver disease should consult a doctor before use.

There is also an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised 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, patients should consult a doctor promptly.

Patients should stop use and consult a doctor if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is present, as these may indicate a serious condition.

Additionally, it is recommended that patients consult a doctor or pharmacist before use 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 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 Children Pain Relief. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Children Pain Relief.
Details

Pediatric Use

Pediatric patients under 24 lb (under 2 years) should consult a doctor for dosing recommendations. For those weighing 24-35 lb (2-3 years), the recommended dose is 1 tablet; for 36-47 lb (4-5 years), 1 1/2 tablets; for 48-59 lb (6-8 years), 2 tablets; for 60-71 lb (9-10 years), 2 1/2 tablets; and for 72-95 lb (11 years), 3 tablets. Dosing should primarily be based on weight; if weight is not available, age may be used as a secondary guide.

Safety precautions are critical. The recommended dosage should not be exceeded, and no more than 5 doses should be administered within a 24-hour period. Treatment should not extend beyond 5 days unless directed by a healthcare professional. There is a significant risk of severe liver damage if a child takes more than 5 doses in 24 hours or if combined with other medications containing acetaminophen. Additionally, acetaminophen may cause severe skin reactions, including skin reddening, blisters, or rash; if any of these symptoms occur, use should be discontinued immediately, and medical assistance sought. Parents should also be vigilant for severe sore throat symptoms that persist beyond 2 days or are accompanied by fever, headache, rash, nausea, or vomiting, and consult a doctor if these occur. Prior to use, a healthcare provider should be consulted if the child has liver disease or is taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is necessary. Parents and caregivers should contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are apparent. Prompt intervention is essential for both children and adults.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information primarily emphasizes pediatric use and does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, as the absence of data may necessitate careful monitoring and individualized assessment of treatment risks and benefits.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information available regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a concurrent liver disease. It is essential to assess the patient's overall health status and any potential interactions that may arise due to reduced kidney function. Monitoring renal function and adjusting dosing as necessary may be required to ensure safety and efficacy 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 assess liver function and consider potential dosage adjustments 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 crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the management of an overdose may vary depending on the specific substance involved and the clinical presentation of the patient. Continuous monitoring and supportive care may be necessary to address any potential complications that arise from the overdose.

It is essential to gather as much information as possible regarding the substance taken, the amount, and the time of ingestion, as this will aid in the assessment and management of the situation.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, 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 to refrain from using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation.

Patients should be counseled to discontinue use and consult a doctor if pain worsens or persists for more than 5 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. Additionally, healthcare providers should advise patients to consult a doctor before use if their child has liver disease. It is also recommended that patients 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 a tamper-evident seal. It is essential to ensure that the safety seal under the cap is intact; do not use the product if the seal is broken or missing.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F). However, excursions are permitted within a range of 15°-30°C (59°-86°F). Proper handling and storage are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period and that the medication is not used for more than 5 consecutive days unless directed by a healthcare professional.

Drug Information (PDF)

This file contains official product information for Children Pain Relief, 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 Children Pain Relief, 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.

Learn more in our Editorial Policy

Last AI update:

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.