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Childrens Acetaminophen

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This product has been discontinued

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 2016
Label revision date
August 17, 2016
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 2016
Label revision date
August 17, 2016
Manufacturer
We Care Distributors Inc.
Registration number
part343
NDC root
70005-041
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

Children's Pain Relief is a cherry-flavored suspension liquid designed for children ages 2 to 11. This medication is used to temporarily reduce fever and relieve minor aches and pains associated with common conditions such as the cold, flu, headache, sore throat, and toothache. It contains an active ingredient similar to that found in Children's Tylenol®, making it a familiar choice for parents seeking relief for their children.

Uses

You can use this medication to temporarily reduce fever and relieve minor aches and pains. It’s effective for discomfort caused by common conditions such as the cold and flu, as well as headaches, sore throats, and toothaches.

If you're feeling unwell with any of these symptoms, this medication can help you feel more comfortable while your body fights off the illness. Always remember to follow the recommended guidelines for use.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. It's important to use only the dosing cup that comes with the product, as other devices may not provide the correct amount. You can repeat the dose every 4 hours as long as your symptoms persist, but remember not to 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.

When it comes to dosing based on weight and age, here’s a quick guide: If your child weighs under 24 pounds and is under 2 years old, consult your doctor before giving any dose. 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), the dose is 12.5 mL. Finally, if your child weighs between 72 to 95 pounds (age 11 years), the dose is 15 mL. Always check with your doctor before giving any medication to your child.

What to Avoid

You should avoid using this medication if you are taking any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. 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.

It's also important to follow the recommended dosage carefully and not exceed it, as doing so can lead to serious health risks. Always be mindful of these guidelines to ensure safe use of the medication.

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, if your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it's important to consult a doctor right away.

It's also crucial to stop using the product and seek medical advice if new symptoms arise, if there is redness or swelling, if pain worsens or lasts more than 5 days, or if a fever persists for more than 3 days, as these may indicate a serious condition. Before using this product, consult a doctor 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. It contains acetaminophen, which can cause severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications that also contain acetaminophen. 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, you should consult a doctor right away.

Always be cautious about the dosage. Taking more than the recommended amount can lead to liver damage. If an accidental overdose occurs, seek professional help or contact a Poison Control Center immediately, even if there are no noticeable symptoms. Additionally, if your child develops new symptoms, experiences redness or swelling, has worsening pain lasting more than 5 days, or has a fever that lasts more than 3 days, stop using the product and call your doctor, as these may indicate a serious condition.

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 medication during pregnancy, there are no specific guidelines or safety concerns mentioned. This means that there is no detailed information available about how the medication may affect you or your baby, including any necessary dosage adjustments or special precautions you should take.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider to ensure the best care for you and your baby. Always prioritize open communication with your doctor about any concerns you may have regarding medication use during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

When considering medication for your child aged 2 to 11, it's important to follow specific dosing guidelines based on their weight. For children under 24 pounds, you should consult a doctor before giving any medication. For those weighing between 24 to 95 pounds, the recommended doses vary: for 24-35 pounds (ages 2-3), give 5 mL; for 36-47 pounds (ages 4-5), give 7.5 mL; for 48-59 pounds (ages 6-8), give 10 mL; for 60-71 pounds (ages 9-10), give 12.5 mL; and for 72-95 pounds (age 11), give 15 mL.

Always check with your doctor before administering any medicine to your child, especially if they have liver disease or are taking blood thinners like warfarin. Remember not to exceed the recommended dose, which should not be given more than five times in 24 hours or for more than five days unless directed by a doctor.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available in the drug insert. This means that healthcare providers may not have detailed guidelines tailored for elderly patients. If you or a loved one is an older adult considering this medication, it’s important to discuss any concerns with your doctor. They can help determine the best approach based on individual health needs and any other medications being taken.

Always ensure that your healthcare provider is aware of any age-related health considerations, as older adults may have different responses to medications compared to younger individuals.

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 without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

Hepatic Impairment

If you or your child 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 ensure safety, always check the labels of any other medications you may be using and consult with your healthcare provider if you have any concerns about liver function or dosage. Monitoring your liver health is crucial, so keep your doctor informed about any changes or symptoms you may experience.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if your child is taking warfarin, a blood-thinning drug. Mixing these medications can lead to serious complications, so always check first.

Additionally, avoid using this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication has acetaminophen, don't hesitate to ask a healthcare professional for guidance. Keeping open communication with your healthcare provider helps ensure safe and effective treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15 - 30°C (59 - 86°F). It's important to keep it away from freezing temperatures, as this can damage the product. Additionally, make sure to protect it from light to maintain its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. Following these guidelines will help ensure the product remains safe and effective for your use.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as 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.

Before giving this medication to your child, consult with a doctor if they have liver disease or are taking the blood thinner warfarin. Always check with your doctor before administering any medicine to your infant or child to ensure it is safe and appropriate for their specific situation.

FAQ

What is Children's Pain Relief?

Children's Pain Relief is a cherry-flavored suspension liquid designed for children ages 2 to 11, available in a 2 FL OZ (60 mL) bottle.

What does Children's Pain Relief do?

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

How should I administer Children's Pain Relief?

Shake well before using and use only the enclosed dosing cup. Repeat the dose every 4 hours while symptoms last, but do not exceed 5 doses in 24 hours.

What are the dosage recommendations based on weight and age?

For children 2-3 years (24-35 lb), the dose is 5 mL; for 4-5 years (36-47 lb), it's 7.5 mL; for 6-8 years (48-59 lb), it's 10 mL; for 9-10 years (60-71 lb), it's 12.5 mL; and for 11 years (72-95 lb), it's 15 mL.

Are there any warnings associated with Children's Pain Relief?

Yes, do not exceed the recommended dose, as taking more than 5 doses in 24 hours can cause severe liver damage. Consult a doctor if symptoms persist or worsen.

Can I use Children's Pain Relief if my child has liver disease?

You should ask a doctor before using this product if your child has liver disease.

Is it safe to use Children's Pain Relief with other medications?

Do not use it with any other drug containing acetaminophen. If unsure, consult a doctor or pharmacist.

What should I do in case of an overdose?

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

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

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

What are the storage instructions for Children's Pain Relief?

Store between 15 - 30°C (59 - 86°F), protect from freezing, and keep away from light.

Packaging Info

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

Packaging configurations for Childrens Acetaminophen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is a suspension liquid formulation intended for pediatric use, specifically for children aged 2 to 11 years. It contains an active ingredient comparable to that found in Children's Tylenol®. The product is presented in a cherry flavor to enhance palatability. Each bottle contains 2 fluid ounces (60 mL) of the suspension.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

The product must be shaken well before each use. Administration should only be performed using the enclosed dosing cup specifically designed for this product; the use of any other dosing device is not recommended.

Dosing is based on the weight and age of the patient as follows:

  • For patients weighing under 24 lb. (under 2 years of age), consult a doctor for appropriate dosing.

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

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

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

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

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

Doses may be repeated every 4 hours while symptoms persist, but should not exceed 5 doses in a 24-hour period. Continuous administration beyond 5 days is not advised unless directed by a healthcare professional. Always consult with a doctor before administering this medication to infants or children.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, 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.

  • In patients with a known allergy to acetaminophen or any of the inactive ingredients in this product, as this may lead to severe allergic reactions.

  • Exceeding the recommended dose is contraindicated due to the potential for overdose, which can result in serious health consequences.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed five doses within a 24-hour period or if it is used concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to mitigate the risk of liver injury.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Healthcare providers should emphasize the importance of avoiding overdose, as taking more than the recommended dose can lead to significant liver damage. In the event of an accidental overdose, immediate professional assistance should be sought, and contacting a Poison Control Center is strongly recommended. Quick medical intervention is crucial, even if the patient does not exhibit any immediate signs or symptoms of overdose.

Patients should be instructed to discontinue use and contact their healthcare provider if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days. These developments may signal a serious condition that necessitates further medical assessment.

Side Effects

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

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. Therefore, it is crucial for patients to adhere strictly to the recommended dosage guidelines.

In addition, a sore throat warning is in place for patients experiencing severe throat pain. If the sore throat persists for more than two days or is accompanied by symptoms such as fever, headache, rash, nausea, or vomiting, it is advised that patients consult a healthcare professional promptly, as these may indicate a serious condition.

Patients are also advised to discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, if pain worsens or lasts longer than five days, or if fever intensifies or persists beyond three days. These symptoms could signify a serious underlying condition that requires medical evaluation.

Before using this product, it is recommended that patients consult a healthcare provider if there is a history of liver disease. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use, as interactions may occur.

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. Co-administration may lead to an increased risk of acetaminophen-related toxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

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

Packaging configurations for Childrens Acetaminophen.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication with specific dosing guidelines based on weight. For children under 24 lb (under 2 years), consultation with a doctor is advised prior to administration. The recommended dosages for children aged 2 to 11 years are as follows:

  • 24-35 lb (2-3 years): 5 mL

  • 36-47 lb (4-5 years): 7.5 mL

  • 48-59 lb (6-8 years): 10 mL

  • 60-71 lb (9-10 years): 12.5 mL

  • 72-95 lb (11 years): 15 mL

It is crucial to check with a healthcare provider before administering this medication to any infant or child. The maximum recommended dose should not be exceeded, and the medication should not be given more than five times within a 24-hour period or for more than five consecutive days unless directed by a physician.

Caution is advised for pediatric patients with liver disease, and consultation with a doctor or pharmacist is recommended if the child is concurrently taking the anticoagulant warfarin.

Geriatric Use

There is no specific information regarding the use of this drug in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, given the physiological changes associated with aging that may affect drug metabolism and response. Additionally, consideration should be given to the possibility of altered pharmacokinetics and pharmacodynamics in geriatric patients, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

There is no specific mention of pregnancy use, safety concerns, dosage modifications, or special precautions regarding use during pregnancy in the provided text. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to adhere to the recommended dosage guidelines to prevent severe liver damage. Specifically, patients must not exceed 5 doses within a 24-hour period, as this represents the maximum daily amount. Additionally, caution is advised when administering this product in conjunction with other medications that also contain 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.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage, particularly in pediatric patients.

Risk of Liver Damage Administration of more than five doses within a 24-hour period exceeds the maximum recommended daily amount and significantly increases the risk of severe liver damage. Healthcare professionals should be vigilant in monitoring patients who may have inadvertently exceeded this dosage.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk for liver injury. It is essential to assess the patient's medication history 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 providers should initiate appropriate management protocols, which may include supportive care and monitoring of liver function tests. Early intervention is crucial to mitigate the risk of long-term hepatic complications.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an accidental overdose, patients should be instructed to seek professional assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be cautioned against using 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 with a doctor or pharmacist for clarification.

It is important to inform patients that this product should not be used if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Healthcare providers should also instruct patients to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dose, reiterating the overdose warning. Additionally, healthcare providers should recommend that patients 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 various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 15 to 30°C (59 to 86°F). Care must be taken to protect the product from freezing, as well as from light exposure to maintain its integrity and efficacy.

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 the total administration does not exceed 5 doses within a 24-hour period and should not extend beyond 5 days unless directed by a physician.

Patients or caregivers should be advised to consult a doctor prior to use if the child has liver disease. Additionally, it is important to seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin. Always verify with a healthcare professional before giving any medication to an infant or child.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Childrens Acetaminophen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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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.