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Childrens Pain Relief

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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 2020
Label revision date
October 2, 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 2020
Label revision date
October 2, 2024
Manufacturer
Publix Super Markets Inc
Registration number
M013
NDC root
56062-130
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

ACETAMINOPHEN is an oral suspension medication designed for children aged 2 to 11 years. It is a pain reliever and fever reducer that provides fast and effective relief from minor aches and pains associated with conditions like the common cold, flu, headache, sore throat, and toothache. This formulation is free from ibuprofen, alcohol, and aspirin, making it a suitable option for young children.

With a pleasant grape flavor, ACETAMINOPHEN comes in a 4 FL OZ (118 mL) bottle, delivering 160 mg of the active ingredient per 5 mL. It works by reducing fever and alleviating discomfort, helping your child feel better when they are unwell.

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 under the weather, making it easier to manage your symptoms and feel more comfortable.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. You’ll need to find the right dose for your child based on their weight or age. If your child weighs less than 24 pounds or is under 2 years old, it’s best to ask a doctor for guidance. For children weighing between 24 to 35 pounds (ages 2-3 years), the dose is 5 mL. If your child weighs 36 to 47 pounds (ages 4-5 years), the dose increases to 7.5 mL. For those weighing 48 to 59 pounds (ages 6-8 years), the dose is 10 mL, and for children weighing 60 to 71 pounds (ages 9-10 years), it’s 12.5 mL. Finally, if your child weighs between 72 to 95 pounds (age 11 years), the dose is 15 mL.

When administering the medication, remove the child protective cap and squeeze the correct dose into the enclosed dosing cup. You can repeat this dose every 4 hours as long as your child continues to have symptoms, but remember not to give more than 5 doses in a 24-hour period. Always use the dosing cup that comes with the product, as other devices may not provide accurate measurements.

What to Avoid

You should avoid using this product if your child has ever had an allergic reaction to it or any of its ingredients. Additionally, do not combine it with any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, it's important to consult with a doctor or pharmacist.

Always follow the recommended dosage and be cautious not to exceed it, as doing so can lead to serious health risks. If you have any questions or concerns about using this product, please reach out to a healthcare professional for guidance.

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. Additionally, be aware that acetaminophen may 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.

You should also 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. It's important to stop use and seek medical advice 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.

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. 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. You should also stop using the product 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. In case of an overdose, seek medical help or contact a Poison Control Center at 1-800-222-1222 immediately, even if no symptoms are present. Quick medical attention is crucial.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick action is crucial, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or have concerns about an overdose, don’t hesitate to get help right away. Your safety is the top priority.

Pregnancy Use

When it comes to using acetaminophen during pregnancy, there is currently no specific information available about its safety, recommended dosage, 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 taking acetaminophen or any medication. They can help you weigh the potential benefits and risks based on your individual health needs. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, 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, and the effects on your nursing infant have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of both you and your baby.

Pediatric Use

When giving this medication to children aged 2 to 11 years, it's important to follow the recommended dosages based on their weight and age. For children under 24 pounds, you should consult a doctor before administering the medication. For those weighing between 24 to 95 pounds, the dosage varies: children aged 2-3 years should receive 5 mL, 4-5 years should get 7.5 mL, 6-8 years should have 10 mL, 9-10 years should take 12.5 mL, and 11 years old should receive 15 mL.

Make sure not to exceed the recommended dose, and do not give the medication more than five times in a 24-hour period. If possible, use your child's weight to determine the dose; if not, you can use their age. Always use the enclosed dosing cup that comes with the product, as other devices may not provide the correct measurement.

Geriatric Use

When considering this medication for older adults, it's important to note that the product does not provide specific directions or complete warnings for adult use. This means that if you or a loved one is an older adult, you should consult with a healthcare professional to ensure that the medication is appropriate and safe for your individual health needs.

Always discuss any existing health conditions or medications you are taking, as older adults may have different responses to medications compared to younger individuals. Your healthcare provider can help determine the right dosage and monitor for any potential side effects.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.

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 can 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 and safety of your product, store it in a cool, dry place at a temperature between 68-77°F (20-25°C). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to check the printed neckband before use. If it is broken or missing, do not use the product, as this could indicate a safety issue. Following these guidelines will help you use the device safely and effectively.

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. It's important to consult a doctor before use if your child has liver disease or is 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 using the medication and seek medical advice. Additionally, watch for any new symptoms, redness, or swelling. Always keep this medication out of reach of children, and in case of an overdose, seek immediate medical help or contact a Poison Control Center at 1-800-222-1222, even if no symptoms are present.

FAQ

What is ACETAMINOPHEN used for?

ACETAMINOPHEN is a pain reliever and fever reducer for children aged 2 to 11 years, effective for minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

What is the recommended dosage for ACETAMINOPHEN?

Dosage varies by weight and age. For example, children aged 2-3 years weighing 24-35 lbs should take 5 mL, while those aged 11 years weighing 72-95 lbs should take 15 mL.

How often can I give ACETAMINOPHEN to my child?

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

Are there any warnings associated with ACETAMINOPHEN?

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

Can I use ACETAMINOPHEN if my child has allergies?

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

Is it safe to use ACETAMINOPHEN during pregnancy?

The insert does not provide specific information regarding the use of acetaminophen during pregnancy, so consult a doctor for guidance.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

How should I store ACETAMINOPHEN?

Store ACETAMINOPHEN at 68-77°F (20-25°C) and do not use it if the printed neckband is broken or missing.

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

Acetaminophen is an oral suspension formulated to provide pain relief and reduce fever. Each 5 mL of the suspension contains 160 mg of acetaminophen. The product is presented in a grape flavor and is packaged in a 4 fluid ounce (118 mL) bottle.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, influenza, headache, sore throat, and toothache.

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

Dosage and Administration

This product is intended for pediatric use only, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the child's weight or age. It is essential to shake the product well before each use.

To administer the dose, remove the child protective cap and squeeze the appropriate amount into the enclosed dosing cup. The recommended dosing intervals are every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period.

The following dosage chart provides specific dosing recommendations:

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

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

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

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

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

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

It is critical to adhere to the maximum dosing limits and to use only the enclosed dosing cup specifically designed for this product. Other dosing devices should not be used. Healthcare professionals should also be aware that this product does not contain complete warnings for adult use and should not exceed the recommended dosage.

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. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

  • This product should not be administered to children who have a history of allergic reactions to this product or any of its components.

  • Exceeding the recommended dosage is contraindicated; refer to the overdose warning for further details.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise that no more than 5 doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a prompt consultation with a physician is recommended.

Patients should be instructed to stop use and consult a healthcare professional if any of the following occur: pain worsens or lasts longer than 5 days, fever worsens or persists beyond 3 days, new symptoms develop, or if redness or swelling is observed. These symptoms may indicate the presence of a serious underlying condition.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as rapid intervention is essential for optimal outcomes.

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 concurrently with other medications containing acetaminophen.

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. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding 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, it is recommended that they consult a healthcare professional promptly.

Patients are advised to stop using the product and seek medical advice 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 there is any redness or swelling present, as these may indicate a serious 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 other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. 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 aged 2 to 11 years may receive this medication with specific dosing guidelines based on weight and age. For children weighing under 24 pounds and under 2 years of age, consultation with a healthcare provider is advised. The recommended doses for children in the specified age ranges are as follows:

  • 24-35 pounds (2-3 years): 5 mL

  • 36-47 pounds (4-5 years): 7.5 mL

  • 48-59 pounds (6-8 years): 10 mL

  • 60-71 pounds (9-10 years): 12.5 mL

  • 72-95 pounds (11 years): 15 mL

It is crucial not to exceed the recommended dose, and the medication should not be administered more than five times within a 24-hour period. When possible, dosing should be based on weight; if weight is not available, age may be used as a guide.

Healthcare professionals should instruct caregivers to use only the enclosed dosing cup specifically designed for this product and to avoid using any other dosing devices to ensure accurate administration.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. Healthcare providers should exercise caution and closely monitor geriatric patients for any adverse effects or complications that may arise due to the lack of specific guidance. It is advisable to assess the individual needs and health status of elderly patients before prescribing this product, as the absence of comprehensive information may necessitate dose adjustments or alternative therapeutic options.

Pregnancy

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

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert 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 absence of detailed guidance 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 consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to evaluate liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful assessment and ongoing monitoring may be necessary to ensure the safe and effective use of the medication in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential, as quick medical attention can significantly impact the outcome, 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 complications. Therefore, monitoring and evaluation should be conducted as soon as possible following an overdose incident.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical 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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing that prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients must be cautioned against exceeding the recommended dose, as this could lead to overdose. Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a configuration that includes a printed neckband. It is essential to ensure that the neckband is intact; do not use the product if the printed neckband is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 68-77°F (20-25°C). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended repeat dose every 4 hours while symptoms persist, not exceeding 5 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor before use if the patient has liver disease or is taking warfarin, a blood-thinning medication. Patients are advised to discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. It is crucial to keep the medication out of reach of children, and in the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222, as prompt attention is essential even if no symptoms are apparent.

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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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.