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Childrens Motrin

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
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
November 8, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
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
November 8, 2024
Manufacturer
Kenvue Brands LLC
Registration number
NDA020516
NDC root
50580-603
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Drug Overview

Children's Motrin® is an oral suspension that contains ibuprofen, a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). It is designed to relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever and provides relief that can last up to 8 hours.

This medication is suitable for children aged 2 to 11 years and comes in a grape flavor, making it more palatable for young ones. Each 5 mL dose contains 100 mg of ibuprofen, and the product is alcohol-free.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It’s also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer choice for those who may be pregnant.

Dosage and Administration

Before using this product, make sure to shake the bottle well. It's important to follow the dosing instructions carefully. You should find the right dose by referring to the dosing chart, which considers both weight and age. If possible, use your child's weight to determine the dose; if not, you can use their age instead. Always use the enclosed dosing cup to measure the medication—do not use any other device.

For most children, you can repeat the dose every 6 to 8 hours if needed, but remember not to exceed four doses in a single day. If your child weighs under 24 pounds or is under 2 years old, it's best to consult a doctor for the appropriate dose. For children weighing between 24 and 35 pounds (ages 2-3 years), the dose is 5 mL. As the weight increases, so does the dose, with specific amounts outlined for different weight ranges and ages. Always ensure you do not give more than directed.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of a severe allergy may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as fainting, vomiting blood, or has bloody or black stools, seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always check with a healthcare professional before giving ibuprofen if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using the medication and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without consulting a doctor, especially if they have a severe sore throat with high fever, headache, nausea, or vomiting. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any particular guidelines or risks associated with its use. There are no stated contraindications (conditions that would make the use of a drug inadvisable) or special precautions for pregnant individuals. Additionally, the text does not provide any recommendations for dosage modifications for those who are pregnant.

While the absence of warnings may seem reassuring, it's always best to consult with your healthcare provider before taking any medication during pregnancy. They can provide personalized advice based on your specific situation and health needs.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

If you have a child between the ages of 2 and 11 years, it's important to follow specific dosing guidelines. For children under 2 years old and weighing less than 24 pounds, you should consult a doctor before use. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for those aged 4 to 5 years (36-47 lbs), 10 mL for 6 to 8 years (48-59 lbs), 12.5 mL for 9 to 10 years (60-71 lbs), and 15 mL for 11 years (72-95 lbs).

It's crucial not to use this medication for children under 3 years old unless directed by a doctor. Always consult a healthcare professional if your child has a history of stomach issues, is taking other medications, or has experienced significant fluid loss from vomiting or diarrhea. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, stop using the medication and seek medical advice.

Geriatric Use

When considering the use of Children's Motrin (ibuprofen suspension) for older adults, it's important to note that the drug insert does not provide specific information about how it may affect this age group. This means there are no detailed guidelines on dosage adjustments, safety concerns, or special precautions for elderly patients.

If you are caring for an older adult, it's always best to consult with a healthcare professional before starting any new medication. They can provide personalized advice based on individual health needs and conditions.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and may suggest necessary adjustments to your treatment plan. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of the treatment.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these conditions can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware of potential interactions when taking medications. For instance, if you or your child is allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases significantly. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

If your child is prescribed a diuretic (a medication that helps remove excess fluid from the body), it's crucial to consult with a healthcare provider before starting ibuprofen. Always discuss any medications or tests with your healthcare provider to ensure safety and avoid serious complications.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness and safety.

Before using the product, check that the carton is unopened and that the "SAFETY SEAL®" on the bottle wrap is intact. If the carton is opened or the seal is broken or missing, do not use the product, as this may compromise its safety. Always handle the product with care to ensure it remains in good condition.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. It's important to keep this medication out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Children's Motrin®?

Children's Motrin® is an oral suspension containing ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), used as a pain reliever and fever reducer.

What age group can use Children's Motrin®?

Children's Motrin® is intended for children aged 2 to 11 years.

How should I dose Children's Motrin®?

You should find the right dose on the dosing chart based on your child's weight or age, and use only the enclosed dosing cup.

What are the common uses of Children's Motrin®?

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

What should I do if my child experiences side effects?

Stop use and consult a doctor if your child shows signs of stomach bleeding, heart problems, or does not get relief within 24 hours.

Are there any warnings associated with Children's Motrin®?

Yes, it may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke.

Can I give Children's Motrin® to my child if they have allergies?

Do not use Children's Motrin® if your child has had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

What should I do if my child has a history of stomach problems?

Consult a doctor before using Children's Motrin® if your child has a history of stomach issues or is taking other medications.

Is it safe to use Children's Motrin® during pregnancy or while nursing?

The provided information does not specify any risks or precautions regarding the use of ibuprofen during pregnancy or lactation.

How should I store Children's Motrin®?

Store Children's Motrin® between 20-25°C (68-77°F) and do not use if the carton is opened or the safety seal is broken.

Packaging Info

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

Packaging configurations for Childrens Motrin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Motrin® is an ibuprofen oral suspension formulated for pediatric use in children aged 2 to 11 years. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) that serves as a pain reliever and fever reducer. The suspension is alcohol-free and is presented in a grape flavor to enhance palatability. The product is packaged in a 4 fl oz (120 mL) bottle, providing relief that lasts up to 8 hours. The National Drug Code (NDC) for this formulation is 50580-603-04.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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 to determine the appropriate dose based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of four doses per day. The following dosing chart provides specific dosage recommendations:

  • For patients weighing under 24 lbs or under 2 years of age, the dose should be determined by consulting a physician.

  • For patients weighing between 24-35 lbs or aged 2-3 years, the recommended dose is 5 mL.

  • For patients weighing between 36-47 lbs or aged 4-5 years, the recommended dose is 7.5 mL.

  • For patients weighing between 48-59 lbs or aged 6-8 years, the recommended dose is 10 mL.

  • For patients weighing between 60-71 lbs or aged 9-10 years, the recommended dose is 12.5 mL.

  • For patients weighing between 72-95 lbs or aged 11 years, the recommended dose is 15 mL.

Healthcare professionals should ensure that patients do not exceed the recommended dosage and should advise caregivers to seek medical guidance if there are any uncertainties regarding dosing for patients under 24 lbs or under 2 years of age.

Contraindications

Use is contraindicated in patients who have a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with a risk of severe stomach bleeding. The likelihood of such an event is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment increases this risk.

NSAIDs, with the exception of aspirin, are linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised in such cases. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

It is crucial to discontinue use and consult a physician if the child exhibits any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, signs of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, a healthcare provider should be consulted. Any new symptoms that arise should also prompt a medical evaluation.

In cases of overdose, it is essential to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for severe stomach bleeding. The risk of this serious adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, prolonged use or exceeding the recommended dosage increases the likelihood of stomach bleeding.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified with higher doses or extended duration of use.

Common adverse reactions may include severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. Such symptoms warrant prompt medical consultation.

Patients are advised to discontinue use and seek medical attention if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also necessitate immediate medical evaluation.

If a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should consult a healthcare provider. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt medical advice.

Before using this product, patients should consult a healthcare professional if they have a history of stomach issues, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Additional caution is advised for patients with dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as those with asthma or those taking diuretics. It is also recommended that patients under a doctor's care for any serious condition or those taking other medications consult a healthcare provider or pharmacist prior to use.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin.

When considering the concomitant use of ibuprofen with anticoagulants or steroid medications, there is an increased risk of gastrointestinal bleeding. This risk is also elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

In pediatric patients, it is advisable to consult a healthcare professional if the child is concurrently receiving diuretic therapy, as this may necessitate careful monitoring or dosage adjustments.

Packaging & NDC

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

Packaging configurations for Childrens Motrin.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may use this medication, with specific dosing guidelines based on weight. For children under 24 lbs, use is not recommended without consulting a doctor. The recommended dosages for children aged 2 to 11 years are as follows:

  • 24-35 lbs (2-3 years): 5 mL

  • 36-47 lbs (4-5 years): 7.5 mL

  • 48-59 lbs (6-8 years): 10 mL

  • 60-71 lbs (9-10 years): 12.5 mL

  • 72-95 lbs (11 years): 15 mL

It is important to note that this medication should not be used in children under 3 years of age unless directed by a healthcare professional.

Healthcare providers should advise parents to consult a doctor if the child has a history of stomach problems, is taking other medications, or has experienced significant fluid loss due to vomiting or diarrhea. Additionally, if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, parents should stop use and seek medical advice.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Children's Motrin (ibuprofen suspension). As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients, particularly those aged 65 and older.

Due to the lack of specific information regarding geriatric use, it is advisable for healthcare providers to closely monitor elderly patients for any potential adverse effects or changes in response to treatment. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of ibuprofen suspension for this population.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided information. The prescribing information does not mention any contraindications or risks associated with ibuprofen use during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. The text also does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment course.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. Careful consideration should be given to the overall health status of these patients, particularly if they also have comorbidities such as high blood pressure, heart disease, kidney disease, or a history of stroke.

Regular follow-up and reassessment of liver function are crucial 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 without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to address any complications that may arise during the management of an overdose.

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

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports include gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis and various skin reactions. Additionally, cases of liver injury have been documented. There have also been reports of cardiovascular events, such as heart attack and stroke, linked to the use of NSAIDs, including ibuprofen. Furthermore, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been noted in the postmarketing data.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be instructed to stop using the medication and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling, they should also discontinue use and seek medical advice.

It is important to inform patients that if the child does not experience relief within the first 24 hours of treatment, they should stop use and consult a doctor. Furthermore, if fever or pain worsens or persists for more than three days, or if there is any redness or swelling in the painful area, medical consultation is necessary. Patients should also be advised to seek medical attention if any new symptoms arise.

When using this product, patients should take it with food or milk if stomach upset occurs. Healthcare providers should encourage patients to consult a doctor before use if the stomach bleeding warning is applicable to their child, or if the child has a history of stomach issues such as heartburn.

Patients should be advised to seek medical advice if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost significant fluid due to vomiting or diarrhea. Additionally, it is crucial to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Patients should also be reminded to inform their healthcare provider if the child is taking a diuretic or is under a doctor's care for any serious condition. Lastly, it is important to check with a doctor or pharmacist before use if the child is taking any other medications.

Storage and Handling

The product is supplied in a secure carton that must remain unopened until use. It is essential to inspect the carton for any signs of tampering; do not use the product if the carton is opened or if the carton tape or bottle wrap imprinted with "SAFETY SEAL®" is broken or missing.

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

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses in a 24-hour period. Clinicians should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Childrens Motrin, 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 Motrin, 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.