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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
50580-604
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 for children aged 2 to 11 years and is used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever and provides relief that can last up to 8 hours.

This medication comes in a pleasant bubble gum flavor and is alcohol-free, making it easier for children to take. Each 4 fl oz (120 mL) bottle contains 100 mg of ibuprofen per 5 mL of the suspension.

Uses

You can use this medication to help relieve minor aches and pains that may come from common conditions like the cold, flu, sore throat, headache, or toothache. It’s also effective in reducing fever, making you feel more comfortable when you're not feeling well.

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 option for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before using this product, make sure to shake the bottle well. It's important to follow the dosing chart to find the right amount for you or your child. If possible, use weight to determine the dose; if not, you can use age. For example, if your child weighs between 24 and 35 pounds (or is 2-3 years old), the dose is 5 milliliters (mL). If they weigh between 36 and 47 pounds (or are 4-5 years old), the dose increases to 7.5 mL, and so on, up to a maximum of 15 mL for children weighing 72-95 pounds (or 11 years old).

Always use the enclosed dosing cup to measure the dose accurately—do not use any other device. You can repeat the dose every 6 to 8 hours if needed, but remember not to exceed 4 doses in a single day. If your child is under 24 pounds or under 2 years old, it's best to consult a doctor for guidance. Always be cautious and 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. Symptoms of such reactions may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and 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 severe sore throat symptoms, stomach bleeding signs (like faintness, vomiting blood, or black stools), or symptoms of heart problems (such as chest pain or trouble breathing), seek medical attention immediately. Always consult a doctor if your child has a history of stomach issues, is dehydrated, 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 symptoms of heart problems like chest pain or trouble breathing, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, consult a doctor. In case of an overdose, seek 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 or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Do not wait for symptoms to worsen; getting prompt assistance can be vital. Always keep emergency contact information handy and be aware of the signs of overdose to ensure your safety and well-being.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the information regarding the use of Children's Motrin (ibuprofen) during pregnancy is limited. The available data does not specify any risks or contraindications associated with taking ibuprofen while pregnant, nor does it suggest any changes to the usual dosage for pregnant individuals.

However, since there are no specific guidelines or precautions mentioned, it's always best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding and considering using this product, it’s important to consult your doctor first. There is a possibility that the medication can pass into your breast milk, and the effects of ibuprofen on nursing infants have not been thoroughly studied. Because of this uncertainty, it’s wise to be cautious.

While using ibuprofen, keep an eye on your baby for any unusual reactions or side effects. Monitoring your infant can help ensure their safety while you manage your own health needs.

Pediatric Use

When giving this medication to children, it's important to follow specific dosing guidelines based on their weight and age. For children under 24 pounds or under 2 years old, you should consult a doctor before use. For those aged 2 to 3 years and weighing between 24-35 pounds, the recommended dose is 5 mL. As children grow, the dosage increases: 7.5 mL for ages 4-5 years (36-47 lbs), 10 mL for ages 6-8 years (48-59 lbs), 12.5 mL for ages 9-10 years (60-71 lbs), and 15 mL for 11-year-olds (72-95 lbs).

It's crucial to note that this medication should not be used for more than 2 days or given to children under 3 years old without a doctor's guidance. Always consult a doctor if your child has a history of stomach issues, is taking other medications, or is not drinking enough fluids. Keep the medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately.

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 its use in this age group. This means that there may not be tailored guidelines or dosage recommendations specifically for older adults.

If you are caring for an older adult, it's essential to consult with a healthcare professional before administering this medication. They can help determine the appropriate dosage and assess any potential risks, especially if the individual has other health conditions or is taking other medications. Always prioritize safety and seek guidance to ensure the best care.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider needs to know about any existing conditions, such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these can affect how the medication works for you. Always prioritize open communication with your doctor to ensure your safety and the effectiveness of your treatment.

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 (blood tests that check how well your liver is working). This is crucial to ensure that the medication is safe and effective for you.

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

Drug Interactions

It's important to be aware of potential interactions when your child is taking medications. For instance, if 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.

Always consult with your healthcare provider if your child is taking a diuretic (a medication that helps remove excess fluid from the body). Discussing all medications and any lab tests with your doctor is crucial to ensure your child's safety and well-being.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to check the packaging before use; do not use the product if the carton is opened or if the tape or bottle wrap marked "SAFETY SEAL®" is broken or missing. This helps to guarantee that the product remains uncontaminated and safe for your use. Always handle the product with care to maintain its integrity and effectiveness.

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), designed for children ages 2 to 11 years. It acts as a pain reliever and fever reducer.

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. Use only the enclosed dosing cup and do not exceed the recommended dosage.

What are the side effects of Children's Motrin®?

Possible side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke. Consult a doctor if your child experiences any severe symptoms.

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

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

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

The provided information does not specify any risks or contraindications for using Children's Motrin® during pregnancy. Consult a doctor for personalized advice.

What should I do in case of an overdose?

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

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 if the safety seal is broken or missing.

Can I give Children's Motrin® 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 problems, such as ulcers or bleeding issues.

How often can I give Children's Motrin® to my child?

You can repeat the dose every 6-8 hours, but do not exceed 4 doses in a 24-hour period.

What flavor does Children's Motrin® come in?

Children's Motrin® is available in a bubble gum flavor, making it more palatable for children.

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 oral suspension formulation containing ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). Each 5 mL dose delivers 100 mg of ibuprofen. This product is indicated for use in children aged 2 to 11 years and serves as a pain reliever and fever reducer, providing relief that lasts up to 8 hours. The suspension is alcohol-free and is flavored with bubble gum to enhance palatability. The product is available in a 4 fl oz (120 mL) bottle. The National Drug Code (NDC) for this formulation is 50580-604-04.

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 effective in reducing fever.

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

Dosage and Administration

Healthcare professionals should ensure that the product is administered according to the following guidelines. Prior to use, the product must be shaken well. Dosing should be determined using the enclosed dosing chart, which recommends using the patient's weight for dosing whenever possible; if weight is not available, age may be used as an alternative.

The following dosing chart provides specific recommendations:

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

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

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

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

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

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

Administration should be performed using only the enclosed dosing cup; no other dosing devices should be utilized. If necessary, doses may be repeated every 6-8 hours, but it is imperative not to exceed 4 doses in a 24-hour period. It is crucial to adhere strictly to these guidelines to ensure safe and effective use of the product.

Contraindications

Use of this product is contraindicated in the following situations:

  • In patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, due to the risk of severe allergic reactions.

  • In patients undergoing heart surgery, as use immediately before or after such procedures may pose significant risks.

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.

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

NSAIDs, with the exception of aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced 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, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised if symptoms persist beyond two days or if the patient is under three years of age unless otherwise directed by a healthcare provider.

It is crucial to advise caregivers to discontinue use and consult a physician if the child exhibits any of the following signs of potential stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. 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, medical advice should be sought. Any new symptoms that arise should also prompt consultation with a healthcare professional.

In cases of overdose, it is essential to obtain 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 ibuprofen. 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 ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs. The risk of stomach bleeding is heightened if the medication is taken in excess or for prolonged periods.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used beyond the recommended dosage or duration.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting, and should seek medical attention promptly. It is advised to discontinue use and consult a healthcare provider if any of the following symptoms occur: faintness, vomiting blood, bloody or black stools, persistent stomach pain, chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Furthermore, 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, medical advice should be sought. Redness or swelling in the painful area or the emergence of new symptoms also warrants consultation with a healthcare professional.

Patients should not use ibuprofen if they have a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, or if they are scheduled for heart surgery. Prior to use, it is essential to consult a healthcare provider if the patient has a history of stomach problems, has experienced serious side effects from pain relievers, is dehydrated, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Special caution is advised for patients taking diuretics or those under medical care for serious conditions.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to such patients.

In pediatric patients, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. Therefore, it is imperative to monitor these patients closely and consider alternative pain management strategies if necessary.

Additionally, the risk of stomach bleeding is further elevated when ibuprofen is used alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Clinicians should exercise caution and evaluate the necessity of combining these medications.

For children who are prescribed diuretics, it is advisable to consult a healthcare professional prior to initiating ibuprofen therapy. This consultation is essential to assess potential interactions and to ensure safe and effective treatment.

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 require careful consideration when using this medication. Dosing is based on weight and age, with specific recommendations as follows: for children under 24 lbs or under 2 years, consultation with a doctor is advised. For those weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL; for 36-47 lbs (4-5 years), 7.5 mL; for 48-59 lbs (6-8 years), 10 mL; for 60-71 lbs (9-10 years), 12.5 mL; and for 72-95 lbs (11 years), 15 mL.

It is important to note that this medication should not be used for more than 2 days, and it should not be administered to children under 3 years of age unless directed by a healthcare professional. Parents and caregivers should consult a doctor if the child has a history of stomach problems, is taking other medications, or has not been adequately hydrated.

General precautions include keeping the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

Elderly patients may not have specific information regarding the use of Children's Motrin (ibuprofen suspension) as the drug insert does not provide dedicated guidance for this population. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) in older adults.

Due to the lack of specific data, it is advisable for healthcare providers to monitor elderly patients closely for any adverse effects and to consider potential dose adjustments based on individual patient factors, including renal function and concurrent medications. Regular assessment of the patient's response to treatment and any side effects is recommended to ensure safety and efficacy in this demographic.

Pregnancy

There are no specific statements regarding the use of Children's Motrin (ibuprofen) during pregnancy in the provided information. The insert does not mention any contraindications or risks associated with the use of ibuprofen 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 data when advising pregnant patients 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 of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the nursing infant for any adverse effects if the mother is taking ibuprofen.

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 therapy in individuals with reduced kidney function. Monitoring and appropriate dosing adjustments may be necessary to ensure safety and efficacy in this population.

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. It is crucial to consider the overall health status of these patients, including any coexisting conditions such as high blood pressure, heart disease, or kidney disease, which may further complicate their treatment regimen.

Healthcare providers should exercise caution and tailor the treatment plan based on the individual patient's liver function and overall health profile.

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, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

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 several adverse reactions associated with the use of the medication. These include gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis and various skin reactions. Additional adverse reactions reported include elevated liver enzymes, hypertension, and heart failure.

Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Furthermore, there have been reports of cardiovascular events, including myocardial infarction and stroke, linked to the use of nonsteroidal anti-inflammatory drugs (NSAIDs). The safety profile of ibuprofen in pediatric patients is informed by both postmarketing experience and clinical studies.

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 be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed that this medication should not be used if the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important to emphasize that this medication should not be administered right before or after heart surgery.

Healthcare providers should counsel patients to discontinue use 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. Furthermore, patients should be advised to stop use and seek medical attention 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 swelling in the legs.

Patients should also be informed that if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than three days, they should stop use and consult a doctor. Any presence of redness or swelling in the painful area, as well as the emergence of new symptoms, should prompt a discussion with a healthcare provider.

When using this product, patients should be advised to take it with food or milk if stomach upset occurs. It is also crucial for healthcare providers to recommend that patients consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies.

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

Finally, healthcare providers should recommend that patients discuss the use of this medication with a doctor or pharmacist if the child is taking a diuretic or is under medical care for any serious condition, as well as if the child is taking any other medications.

Storage and Handling

The product is supplied in a 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 the option to repeat doses every 6 to 8 hours as needed, not exceeding 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.

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.