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Childrens Pain Relief

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Active ingredient
Acetaminophen 160 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
November 28, 2023
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
Marketed in the U.S.
Since 2023
Label revision date
November 28, 2023
Manufacturer
Better Living Brands, LLC
Registration number
M013
NDC root
21130-223

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Drug Overview

Acetaminophen Chewable Tablets are a pain reliever and fever reducer designed for children aged 2 to 11. Each chewable tablet contains 160 mg of acetaminophen, which temporarily alleviates minor aches and pains associated with common conditions like the cold, flu, headache, sore throat, and toothache. Additionally, these tablets help to reduce fever, making them a useful option for managing discomfort in young ones.

These chewable tablets come in a pleasant bubble gum flavor and are free from aspirin and ibuprofen, providing a gentle alternative for pain relief. They are available in packages of 24, ensuring you have enough on hand for when your child needs it.

Uses

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

Rest assured, there are no known 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 taking this medication, make sure to chew the tablets completely before swallowing; do not swallow them whole. To find the right dose for you or your child, refer to the dosage chart based on weight and age. If possible, use weight for dosing; if not, age can be used as a guide.

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. For children under 24 pounds, it's best to consult a doctor. For those weighing between 24 to 35 pounds, the dose is 1 tablet (for ages 2 to 3 years), while children weighing 36 to 47 pounds should take 1½ tablets (ages 4 to 5 years). If your child weighs between 48 to 59 pounds, the dose is 2 tablets (ages 6 to 8 years), and for those weighing 60 to 71 pounds, it's 2½ tablets (ages 9 to 10 years). Finally, children who weigh between 72 to 95 pounds should take 3 tablets (at age 11). Always follow your doctor’s instructions if they provide specific guidance.

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, if your child has a known allergy to acetaminophen or any of the inactive ingredients in this product, do not use it.

While using this medication, make sure to follow the recommended dosage carefully. Exceeding the recommended dose can lead to serious health risks, so always adhere to the guidelines provided. If you have any questions or concerns, don't hesitate to reach out to a healthcare professional for guidance.

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-thinning medication 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. In case of an overdose, it's crucial to get emergency medical help or contact a Poison Control Center at 1-800-222-1222.

You should also stop using the product and call your doctor if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms appear, or if there is any redness or swelling. These could indicate a more serious condition that needs attention.

Overdose

If your child takes more than 5 doses of this medication in a 24-hour period, it can lead to severe liver damage. This is the maximum amount recommended for safe use. Additionally, combining this product with other medications that contain acetaminophen (a common pain reliever) can also result in serious liver harm.

If you suspect an overdose, look for signs such as unusual tiredness, nausea, vomiting, or yellowing of the skin or eyes. It’s crucial to seek immediate medical help if you notice any of these symptoms or if you believe your child has taken too much of the medication. Always prioritize safety and consult a healthcare professional if you have any concerns.

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 should be avoided during pregnancy, nor does it provide any dosage adjustments or special precautions for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any medication or product to ensure it’s safe for you and 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 acetaminophen, the active ingredient, can pass into your breast milk. Because of this, you should be cautious when considering this medication, as it may pose some risks to your nursing infant. Always prioritize your health and your baby's safety 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 dose is 1 tablet. As your child grows, the dosage increases: 1½ tablets for ages 4 to 5 (36 to 47 pounds), 2 tablets for ages 6 to 8 (48 to 59 pounds), 2½ tablets for ages 9 to 10 (60 to 71 pounds), and 3 tablets for 11-year-olds (72 to 95 pounds).

Be aware of some important warnings. This medication contains acetaminophen, which can cause severe liver damage if your child takes more than 5 doses in 24 hours. Additionally, watch for any signs of a severe skin reaction, such as redness, blisters, or rash, and seek medical help immediately if these occur. 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. Always check with a healthcare professional if your child has liver disease or is taking the blood thinner warfarin. In case of an overdose, seek medical help or contact a Poison Control Center right away, even if there are no immediate symptoms.

Geriatric Use

While there is no specific information about the use of this product in older adults, it is primarily indicated for children aged 2 to 11 years. This means that if you are caring for an older adult, there are no special dosage adjustments or safety concerns noted for them. However, it's always a good idea to consult with a healthcare professional before starting any new medication, especially for older individuals who may have unique health considerations.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 the maximum daily amount recommended. Additionally, be aware that combining this product with other medications that also contain acetaminophen can increase the risk of liver damage.

To protect your liver, always follow the dosing instructions carefully and consult your healthcare provider if you have any questions or concerns about using acetaminophen or any other medications. Your health and safety are the top priority, so make sure to keep track of all medications you are taking.

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 contains 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). It's important to keep it away from high humidity and direct light, as these conditions can affect its quality.

When handling the product, make sure to check that the carton is sealed properly and that the printed seal on the blister is intact. If the carton is open or the seal is broken or missing, do not use the product, as this may compromise its safety and effectiveness.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is Acetaminophen Chewable Tablets used for?

Acetaminophen Chewable Tablets are used to temporarily relieve minor aches and pains due to the common cold, flu, headache, sore throat, and toothache, as well as to reduce fever.

What is the recommended dosage for children?

Dosage is based on weight and age. For example, children weighing 24 to 35 lb (2 to 3 years) should take 1 tablet, while those weighing 72 to 95 lb (11 years) should take 3 tablets.

How should I administer the chewable tablets?

Chew the tablets completely before swallowing; do not swallow them whole.

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

If the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Are there any warnings associated with this product?

Yes, there are several warnings, including the risk of severe liver damage if more than 5 doses are taken in 24 hours or if used with other acetaminophen-containing drugs.

Can I use this product if my child is taking warfarin?

You should ask a doctor or pharmacist before using this product if your child is taking the blood thinning drug warfarin.

Is it safe to use Acetaminophen Chewable Tablets during pregnancy?

There is no specific information regarding the use of this product during pregnancy, so consult a doctor before use.

What should I do in case of an overdose?

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

What are the storage conditions for this product?

Store the tablets between 20° to 25°C (68° to 77°F), avoid high humidity, and protect from light.

What flavor do the chewable tablets have?

The Acetaminophen Chewable Tablets come in a bubble gum flavor.

Packaging Info

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

Packaging configurations for Childrens Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Childrens’s Pain Relief Acetaminophen Chewable Tablets contain 160 mg of acetaminophen as the active ingredient. These chewable tablets are formulated for oral administration and are presented in a bubble gum flavor. Each package contains 24 chewable tablets, and the product is designed for use in children aged 2 to 11 years.

This formulation serves as a pain reliever and fever reducer, and it is both aspirin-free and ibuprofen-free. The product is comparable to the active ingredient found in Children's Tylenol® Chewables. The National Drug Code (NDC) for this product is 21130-223-76. It is important to note that the product should not be used in conjunction with other medications containing acetaminophen. Quality is guaranteed for this formulation.

Uses and Indications

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

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

Dosage and Administration

Chew tablets completely before swallowing; do not swallow tablets whole. The appropriate dosage should be determined using the chart provided below, with weight being the preferred method for dosing. If weight is not available, age may be used as an alternative. Doses may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period.

Dosage is based on weight and age as follows:

  • For patients under 24 lb (under 2 years): Consult a doctor.

  • For patients weighing 24 to 35 lb (2 to 3 years): Administer 1 tablet.

  • For patients weighing 36 to 47 lb (4 to 5 years): Administer 1½ tablets.

  • For patients weighing 48 to 59 lb (6 to 8 years): Administer 2 tablets.

  • For patients weighing 60 to 71 lb (9 to 10 years): Administer 2½ tablets.

  • For patients weighing 72 to 95 lb (11 years): Administer 3 tablets.

Alternatively, dosing may 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.

This product should not be administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation.

Additionally, it is imperative to adhere to the recommended dosage guidelines, as exceeding the recommended dose may lead to serious adverse effects.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals must communicate to patients and caregivers.

Liver Warning Severe liver damage may occur if the maximum daily dosage of acetaminophen, which is five doses within a 24-hour period, is exceeded. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen. It is crucial to monitor the total daily intake of acetaminophen from all sources to prevent potential hepatotoxicity.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning Healthcare professionals should advise patients to consult a physician if a sore throat is severe, persists for more than two days, or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting. These symptoms may indicate a more serious underlying condition that requires prompt medical evaluation.

Emergency Medical Help In cases of overdose, immediate medical attention is necessary. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay.

Monitoring and Follow-Up Patients should be instructed to stop taking the medication and contact their healthcare provider if any of the following occur: pain worsens or lasts longer than five days, fever worsens or persists beyond three days, new symptoms develop, or if redness or swelling is observed. These signs may indicate a serious condition that necessitates further medical investigation.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly those related to liver health and allergic responses.

Severe liver damage may occur if the maximum daily dosage of acetaminophen is exceeded, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen. Patients with pre-existing liver disease should consult a healthcare professional prior to use.

Allergic reactions to acetaminophen can manifest as severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Additionally, patients should be vigilant for signs of a serious condition. If sore throat symptoms are severe, persist for more than two days, or are accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare provider promptly.

Patients are also advised to stop use and seek medical advice if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a more serious underlying condition.

Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product to avoid potential interactions.

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 is heightened when multiple sources of acetaminophen are used simultaneously. 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 Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Pain Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product without consulting a doctor. For children aged 2 to 3 years weighing between 24 to 35 pounds, the recommended dose is 1 tablet. For those aged 4 to 5 years and weighing 36 to 47 pounds, the dose is 1½ tablets. Children aged 6 to 8 years weighing 48 to 59 pounds should receive 2 tablets, while those aged 9 to 10 years weighing 60 to 71 pounds may take 2½ tablets. For children aged 11 years and weighing between 72 to 95 pounds, the dose is 3 tablets.

Healthcare professionals should be aware of several warnings associated with this product. It contains acetaminophen, which can lead to severe liver damage if more than 5 doses are taken within a 24-hour period. Additionally, acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, or rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought. A sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a doctor.

Before administering this product, it is advisable to consult a doctor if the child has liver disease. Furthermore, consultation with a doctor or pharmacist is recommended if the child is taking the blood-thinning medication warfarin.

In the event of an overdose, immediate medical help should be sought, or a Poison Control Center should be contacted. Quick medical attention is crucial for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide data on geriatric use. The product is primarily indicated for children aged 2 to 11 years.

Given the absence of dosage adjustments or safety concerns mentioned for elderly patients, healthcare providers should exercise caution when considering this product for geriatric patients. It is advisable to monitor these patients closely, as individual responses may vary.

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, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which poses a risk of severe liver damage. It is critical that patients do not exceed the maximum daily amount of 5 doses within a 24-hour period. Additionally, patients must avoid concomitant use with other medications that contain acetaminophen to prevent the risk of hepatotoxicity.

Healthcare providers should assess liver function prior to initiating treatment and consider regular monitoring of liver enzymes during therapy, particularly in patients with known liver dysfunction. Adjustments to dosing or alternative therapies may be necessary based on the severity of hepatic impairment.

Overdosage

In cases of overdosage, significant health risks may arise, particularly concerning liver function.

Risk of Severe Liver Damage Administration of more than five doses within a 24-hour period, which exceeds the maximum recommended daily amount, poses a serious risk of severe liver damage in pediatric patients. Healthcare professionals should be vigilant in monitoring for signs of liver impairment in children who may have ingested excessive doses.

Additionally, the concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage. It is crucial for healthcare providers to assess the complete medication history of the patient to identify any potential interactions that could exacerbate the risk of hepatotoxicity.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare professionals should initiate appropriate management procedures, which may include supportive care and monitoring of liver function tests. Prompt intervention is essential to mitigate the potential for serious complications associated with acetaminophen overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

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 and seek medical assistance immediately.

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. It is important to emphasize that quick medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

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

For pediatric patients, healthcare providers must ensure that the product is not administered if the child has a known allergy to acetaminophen or any of the inactive ingredients present in the formulation.

Patients should be instructed 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 develop, or if there is any redness or swelling, as these may indicate a serious condition.

It is crucial to remind patients to adhere strictly to the recommended dosage and to be aware of the overdose warning associated with the product. Additionally, healthcare providers should advise patients to consult a doctor before use if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for identification. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to high humidity and to protect the product from light to maintain its integrity.

Healthcare professionals should ensure that the carton remains unopened and that the printed seal on the blister is intact. If the carton is open or the seal is broken or missing, the product should not be used.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Childrens 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 Childrens 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.

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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.