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Childrens Pain and Fever

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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)
Marketed in the U.S.
Since 2014
Label revision date
June 5, 2024
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
Marketed in the U.S.
Since 2014
Label revision date
June 5, 2024
Manufacturer
Meijer Distribution Inc
Registration number
M013
NDC root
41250-554

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Drug Overview

Meijer® is an oral suspension medication designed specifically for children aged 2 to 11 years. It contains acetaminophen (160 mg per 5 mL), which is a common pain reliever and fever reducer. This medication is effective in providing fast relief from minor aches and pains associated with conditions like the common cold, flu, headaches, sore throats, and toothaches.

With a pleasant cherry flavor, Meijer® is both ibuprofen-free and aspirin-free, making it a suitable option for young children. It is formulated to help reduce fever and alleviate discomfort, ensuring your child feels better quickly.

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 measure the correct dose based on your child's weight or age, using the provided dosing chart. For example, if your child weighs between 24 and 35 pounds and is 2 to 3 years old, the dose is 5 milliliters (mL). If your child weighs between 36 and 47 pounds and is 4 to 5 years old, the dose increases to 7.5 mL. Always use the dosing cup that comes with the product to ensure accuracy.

You can give the dose every 4 hours as needed while your child has symptoms, but remember not to exceed 5 doses in a 24-hour period. If your child weighs less than 24 pounds or is under 2 years old, it’s best to consult a doctor for the appropriate dosage. Always follow the directions carefully to avoid giving more than directed, as this can lead to an overdose.

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, please consult a doctor or pharmacist for guidance.

It's also important to follow the recommended dosage carefully and not exceed it, as doing so can lead to serious health risks. Always prioritize safety and seek professional advice if you have any questions or concerns.

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. Be aware that acetaminophen may also 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.

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. Additionally, if pain worsens or lasts more than 5 days, or if fever persists for more than 3 days, you should seek medical advice. Always check with a healthcare professional if your child has liver disease or is taking blood thinners like warfarin. In case of overdose, contact a Poison Control Center or seek medical help right away, even if no symptoms are present.

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. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any skin reactions, stop using the product and seek medical help immediately. 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, consult a doctor right away.

Before using this product, it's important to ask a doctor if your child has liver disease or is taking the blood thinner warfarin. In case of an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222, even if there are no immediate signs or symptoms. You should also stop using the product and call your 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 may indicate a serious condition.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Even if you don’t see any signs or symptoms, getting quick medical attention is crucial, as some effects may not be immediately apparent.

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 reach out for help. 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 understand the potential risks and benefits 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, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, and the effects of acetaminophen on nursing infants haven't been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

If you do take this medication, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help you weigh the benefits and risks to ensure the safety of both you and your child.

Pediatric Use

When giving this medication to your child, it's important to follow the recommended dosages based on their weight and age. For children under 2 years old who weigh less than 24 pounds, you should consult a doctor before use. For those aged 2 to 11 years, the doses are as follows: 5 mL for children weighing 24-35 pounds (ages 2-3), 7.5 mL for 36-47 pounds (ages 4-5), 10 mL for 48-59 pounds (ages 6-8), 12.5 mL for 60-71 pounds (ages 9-10), and 15 mL for children weighing 72-95 pounds (age 11).

Always ensure you do not exceed the recommended dose, as an overdose can be serious. If your child has liver disease or is taking the blood thinner warfarin, consult a doctor or pharmacist before use. Keep the medication out of reach of children, and if an overdose occurs, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, even if there are no noticeable symptoms. Remember to use only the dosing cup provided with the product for accurate 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 tailored 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 safe and effective use.

Always discuss any existing health conditions or medications with your doctor, as they can help determine the right dosage and monitor for any potential side effects. Your health and safety are the top priority, so don't hesitate to ask questions or seek clarification about how this medication may affect you.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. They will assess your condition and determine if any adjustments to your dosage are necessary. Additionally, if you have liver disease, you should also discuss this with your healthcare provider, as it may affect your treatment plan. Always keep your doctor informed about your health status to ensure safe and effective use of the medication.

Hepatic Impairment

If your child has liver disease, it’s important to consult a doctor before using this medication. Liver disease can affect how the body processes medications, so your healthcare provider will help determine if this treatment is safe and appropriate for your child. Always prioritize their health by seeking professional advice in these situations.

Drug Interactions

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

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

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness. Before using the product, check the printed neckband; do not use it if the neckband is broken or missing, as this could indicate that the product is compromised.

Always handle the product with care to avoid any damage. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. It's important to keep it out of reach of children to prevent accidental ingestion. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial, even if you don't notice any signs or symptoms of overdose.

FAQ

What is Meijer® used for?

Meijer® is used to reduce fever and relieve minor aches and pains in children due to the common cold, flu, headache, sore throat, and toothache.

What is the active ingredient in Meijer®?

The active ingredient in Meijer® is acetaminophen, which is present at a concentration of 160 mg per 5 mL.

What age group is Meijer® suitable for?

Meijer® is suitable for children aged 2 to 11 years.

How should Meijer® be administered?

Meijer® should be administered orally using the enclosed dosing cup. Shake well before use and do not exceed the recommended dose.

What is the recommended dosage for a child weighing 36-47 lbs?

For a child weighing 36-47 lbs, the recommended dosage is 7.5 mL.

Are there any warnings associated with Meijer®?

Yes, do not exceed 5 doses in 24 hours, and avoid using it with other drugs containing acetaminophen. Seek medical help if severe skin reactions or other serious symptoms occur.

Can Meijer® be used 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.

Is Meijer® safe for nursing mothers?

Nursing mothers should consult a doctor before using Meijer®, as acetaminophen may be excreted in breast milk.

What should I do if my child's symptoms persist?

If pain lasts more than 5 days or fever lasts more than 3 days, or if new symptoms occur, stop use and consult a doctor.

Packaging Info

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

Packaging configurations for Childrens Pain and Fever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Acetaminophen is provided in a concentration of 160 mg per 5 mL. The formulation is free from ibuprofen, aspirin, alcohol, and parabens. It is presented in a cherry flavor to enhance palatability. The total volume of the product is 4 fluid ounces (118 mL).

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 does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage is not exceeded, adhering to the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosage chart provided, prioritizing weight for dosing; if weight is not available, age may be used as a secondary reference.

To administer the dose, the child protective cap should be removed, and the prescribed amount should be squeezed into the enclosed dosing cup, which is specifically designed for use with this product.

The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses allowed within a 24-hour period.

Dosage Chart:

  • For children weighing under 24 lb (under 2 years): Consult a doctor for the appropriate dose.

  • For children weighing 24-35 lb (2-3 years): Administer 5 mL.

  • For children weighing 36-47 lb (4-5 years): Administer 7.5 mL.

  • For children weighing 48-59 lb (6-8 years): Administer 10 mL.

  • For children weighing 60-71 lb (9-10 years): Administer 12.5 mL.

  • For children weighing 72-95 lb (11 years): Administer 15 mL.

Dosing should be conducted only with the enclosed dosing cup; the use of any other dosing device is not recommended.

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 a 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 risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than five 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.

Severe skin reactions have been associated with acetaminophen use. 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.

Healthcare providers should also be vigilant regarding sore throat symptoms. If a child presents with a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

Before administering this product, it is advisable to consult a healthcare professional if the child has a history of liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking warfarin or any other anticoagulant medication.

In cases of suspected overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond five days, fever intensifies or lasts more than three days, new symptoms develop, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use it concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

A sore throat warning is also applicable; if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Patients are advised to stop use and contact a doctor 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 redness or swelling is observed, as these may indicate a serious condition.

Prior to use, it is recommended that patients consult a doctor if they have liver disease. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before using this product.

In cases of overdose, immediate medical help should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Quick medical attention is critical, even if no signs or symptoms are immediately apparent.

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 may be heightened, leading to serious hepatic complications. 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 and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Pain and Fever.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to 11 years, dosing is weight-based: 5 mL for those weighing 24-35 lb (2-3 years), 7.5 mL for 36-47 lb (4-5 years), 10 mL for 48-59 lb (6-8 years), 12.5 mL for 60-71 lb (9-10 years), and 15 mL for those weighing 72-95 lb (11 years).

It is crucial not to exceed the recommended dose due to the risk of overdose. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt attention is essential even if no symptoms are present.

Healthcare professionals should advise parents or guardians to consult a doctor if the child has liver disease or is taking the anticoagulant warfarin. The product should be kept out of reach of children, and only the enclosed dosing cup designed for this product should be used for administration. This product does not provide directions or warnings for adult use.

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 essential to evaluate 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, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should consider the lack of information when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with the use of acetaminophen during pregnancy. It is advisable to monitor emerging data and guidelines to inform clinical decision-making in this population.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes this medication.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a concurrent liver disease. It is essential to assess the patient's overall health status and any potential interactions that may arise due to reduced kidney function. Monitoring renal function may be necessary to ensure safe and effective use of the medication in this population.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential, as the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals should be aware that quick medical attention is critical in managing overdose situations. Even in cases where patients do not exhibit any overt symptoms, the risk of delayed effects necessitates thorough evaluation and monitoring. It is advisable to follow established protocols for overdose management, which may include supportive care and symptomatic treatment as indicated.

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 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 use 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 configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed neckband is broken or missing, as this may indicate potential tampering or compromise of the product's integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, it is crucial for patients to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential even if no signs or symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Childrens Pain and Fever, 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 and Fever, 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.