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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
Elixir
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
October 13, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Elixir
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
October 13, 2016
Manufacturer
We Care Distributor Inc.
Registration number
part343
NDC root
70005-049
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Children's Acetaminophen Elixir is a grape-flavored liquid medication designed for children ages 2 to 11. It is primarily used to reduce fever and relieve minor aches and pains associated with common conditions such as the cold, flu, headache, sore throat, and toothache. This medication contains the same active ingredient as Children's Tylenol® Elixir, making it a familiar choice for parents seeking relief for their children.

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 make you feel more comfortable when you're dealing with these everyday ailments. If you're experiencing any of these symptoms, it may be a helpful option for you.

Dosage and Administration

Before using this product, make sure to shake the bottle well. To find the right dose for you or your child, refer to the dosing chart based on weight or age. If possible, it's best to use weight for dosing. For example, if your child weighs between 24-35 pounds and is 2-3 years old, the recommended dose is 5 milliliters (mL).

You can repeat the dose every 4 hours as long as symptoms persist, but remember not to give more than 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 consult with your doctor before giving any medication to infants or children to ensure their safety.

What to Avoid

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

While using this medication, make sure to follow the recommended dosage carefully and avoid exceeding it, as doing so can lead to serious health risks. Always prioritize safety and consult a healthcare professional 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. 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.

Additionally, do not use this product if your child is allergic to acetaminophen or any of its ingredients. If your child has liver disease or is taking the blood thinner warfarin, consult a doctor or pharmacist before use. Be cautious not to exceed the recommended dose, as an overdose can cause liver damage. If new symptoms arise, or if pain or fever worsens or lasts longer than specified, seek medical advice promptly.

Warnings and Precautions

It's important to be cautious when using this product, especially since 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 containing acetaminophen. If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, you should consult a doctor immediately.

Before using this product, ask your doctor if your child has liver disease or is taking the blood-thinning medication warfarin. Always follow the recommended dosage to avoid overdose. If you suspect an overdose, seek medical help or contact a Poison Control Center right away, even if there are no immediate symptoms.

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

Overdose

Taking more than the recommended dose of this medication can lead to serious liver damage. If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Remember, quick action can make a significant difference in ensuring safety and health. Always err on the side of caution and reach out for help if you have any concerns about an overdose.

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 adjustments 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 it is safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, exercising caution is advised. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

If you have a child between the ages of 2 and 11, it's important to follow specific dosing guidelines when giving medication. For children under 24 pounds (usually under 2 years old), you should consult a doctor before administering any medicine. For those aged 2 to 11, the dosage varies by weight: children weighing 24-35 pounds (2-3 years) should receive 5 mL, 36-47 pounds (4-5 years) should get 7.5 mL, 48-59 pounds (6-8 years) should have 10 mL, 60-71 pounds (9-10 years) should take 12.5 mL, and those weighing 72-95 pounds (11 years) can have 15 mL.

Always check with your doctor before giving any medication to your child, especially if they have liver disease or are taking the blood-thinning medication warfarin. Remember not to exceed 5 doses in a 24-hour period and do not use the medication for more than 5 days unless directed by a doctor.

Geriatric Use

While there is no specific information about the use of this product in older adults, it is important to note that the product is primarily indicated for children aged 2 to 11. Since there are no dosage adjustments or safety concerns mentioned for elderly patients, you should consult with a healthcare professional before using this product. They can provide guidance tailored to your individual health needs and any potential interactions with other medications you may be taking. Always prioritize safety and ensure that any treatment is appropriate for your situation.

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 problems, it's important to be cautious with medications that contain acetaminophen. Taking more than 5 doses in 24 hours can lead to severe liver damage, which is the maximum daily amount recommended. Additionally, combining acetaminophen with other medications that also contain it can increase the risk of liver damage.

Before giving this medication to your child, please consult a doctor if they have liver disease. Always follow the recommended dosage closely, as taking too much (an overdose) can harm the liver. If you suspect an overdose, seek medical help or contact a Poison Control Center immediately, even if there are no noticeable symptoms, as prompt attention is crucial for both children and adults.

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 at room temperature, ideally between 15º - 30ºC (59º - 86ºF). It's important to keep it away from freezing temperatures and to protect it from light, as these conditions can affect its effectiveness.

When handling the product, be sure to check the inner cap seal. If the printed seal is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

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 these guidelines to ensure safe and effective use of the medication.

FAQ

What is Children's Acetaminophen Elixir used for?

Children's Acetaminophen Elixir is used to reduce fever and relieve minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

What age group is Children's Acetaminophen Elixir suitable for?

This product is suitable for children ages 2 to 11.

How should I dose Children's Acetaminophen Elixir?

You should find the right dose on the dosing chart based on your child's weight or age. Always check with your doctor before administering.

What are the dosing limits for Children's Acetaminophen Elixir?

Do not give more than 5 doses in 24 hours and do not use for more than 5 days unless directed by a doctor.

Are there any contraindications for using this product?

Do not use this product with any other drug containing acetaminophen or if your child is allergic to acetaminophen or any inactive ingredients.

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 precautions should I take if my child has liver disease?

Ask a doctor before using this product if your child has liver disease.

Can nursing mothers use Children's Acetaminophen Elixir?

Nursing mothers should consult a doctor before using this product, as there is potential for excretion in breast milk.

What are the storage instructions for Children's Acetaminophen Elixir?

Store at room temperature between 15º - 30ºC (59º - 86ºF), protect from freezing and light, and do not use if the inner cap seal is broken or missing.

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

Children's Acetaminophen Elixir is formulated for pediatric use in children aged 2 to 11 years. This elixir is presented in a grape flavor to enhance palatability. The product is contained in a 2 fluid ounce (60 mL) bottle, providing a convenient dosage form for administration.

Uses and Indications

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

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart below to determine the appropriate dosage based on the patient's weight or age. Prior to administration, the product must be shaken well to ensure proper mixing.

Dosing should be repeated every 4 hours as needed while symptoms persist. However, it is important not to exceed 5 doses within a 24-hour period. Continuous use beyond 5 days should only occur under the guidance of a physician.

Dosing Chart:

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

  • For patients weighing 24-35 lb (ages 2-3 years), administer 5 mL.

  • For patients weighing 36-47 lb (ages 4-5 years), administer 7.5 mL.

  • For patients weighing 48-59 lb (ages 6-8 years), administer 10 mL.

  • For patients weighing 60-71 lb (ages 9-10 years), administer 12.5 mL.

  • For patients weighing 72-95 lb (age 11 years), administer 15 mL.

It is essential to always verify the dosage with a healthcare provider 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, 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 used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Warnings and Precautions

Severe liver damage may occur in children who take this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within a 24-hour period or if they use it concurrently with other medications containing acetaminophen.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Healthcare professionals should advise parents to seek medical guidance before administering this product if their child has a history of liver disease. Additionally, consultation with a doctor or pharmacist is recommended if the child is currently taking the anticoagulant warfarin. It is crucial to adhere to the recommended dosage to avoid the risk of overdose.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is essential. Timely medical intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Parents should be instructed to discontinue use and consult a healthcare provider if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days. These symptoms may indicate a serious underlying condition that requires further evaluation.

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 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 doctor before using this product. Additionally, caution is advised for patients taking the blood-thinning medication warfarin, and they should seek guidance from a healthcare professional prior to use.

In the event of a sore throat, patients are advised to seek medical attention if the sore throat is severe, persists for more than two days, or is accompanied by symptoms such as fever, headache, rash, nausea, or vomiting. These symptoms may indicate a serious condition that requires prompt evaluation.

Patients should discontinue use and consult a doctor if new symptoms arise, if there is redness or swelling, if pain worsens or lasts longer than five days, or if fever intensifies or persists beyond three days.

An overdose warning is also critical; taking more than the recommended dose can lead to liver damage. In cases of suspected overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Quick medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

It is important to avoid using this product in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription. Patients should verify the contents of any other medications with a healthcare provider or pharmacist if there is uncertainty regarding acetaminophen inclusion. Furthermore, this product should not be used by individuals who are allergic to acetaminophen or any of the inactive ingredients present in the formulation.

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 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 required 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 consult a healthcare professional before administering this medication to any infant or child. The maximum daily dosage should not exceed 5 doses within a 24-hour period, and treatment should not extend beyond 5 days unless directed by a physician. Additionally, healthcare providers should be consulted if the pediatric patient has liver disease or is concurrently taking the anticoagulant warfarin.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. The product is indicated for use in children ages 2 to 11, and there are no documented dosage adjustments or safety concerns specifically related to elderly patients.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the absence of data on efficacy and safety in this population. Monitoring for potential adverse effects is advisable, given the lack of established guidelines for use in individuals aged 65 and older.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no contraindications noted for pregnant patients, nor are there any associated risks to the fetus identified in the available literature. Additionally, no dosage modifications or special precautions for use during pregnancy have been specified. 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 in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period, as exceeding this limit may lead to severe liver damage. Additionally, patients must be cautioned against the concurrent use of other medications containing acetaminophen, as this can also result in significant hepatic injury.

Before administration, it is advisable for caregivers to consult a healthcare professional if the patient has a history of liver disease. In the event of an overdose, which may occur if the recommended dosage is exceeded, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms of liver damage.

Overdosage

Taking more than the recommended dose may lead to significant liver damage. It is imperative that in the event of an overdose, immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay.

Quick medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Prompt intervention can mitigate potential complications associated with overdose and improve outcomes.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

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

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, or if pain worsens or persists beyond five days. Additionally, patients should be advised to stop use and consult a doctor if fever intensifies or lasts more than three days, as these may indicate a serious underlying condition.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with overdose. Healthcare providers should also recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in a configuration that ensures its integrity and safety. It should be stored at room temperature, specifically within the range of 15º to 30ºC (59º to 86ºF). It is essential to protect the product from freezing and to shield it from light exposure to maintain its efficacy.

Additionally, the product features a tamper-evident design. Healthcare professionals are advised not to use the product if the printed inner cap seal is broken or missing, as this may indicate potential contamination or compromise of the product's safety.

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 advise against use for more than 5 consecutive days unless directed by a healthcare professional.

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.