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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 1995
Label revision date
November 1, 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 1995
Label revision date
November 1, 2024
Manufacturer
Kenvue Brands LLC
Registration number
NDA020516
NDC root
50580-601
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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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 original berry flavor and is alcohol-free, making it suitable for young children. Each 1 fl oz (30 mL) bottle contains 100 mg of ibuprofen per 5 mL, ensuring that it is easy to measure and administer.

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 or planning to become pregnant.

Dosage and Administration

Before using this product, make sure to shake the bottle well. It's important to measure the correct dose using the enclosed dosing cup, as other devices may not provide accurate measurements. To find the right amount for you or your child, refer to the dosing chart based on weight or age. For example, if your child weighs between 24 and 35 pounds, the recommended dose is 5 milliliters (mL).

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 weighs less than 24 pounds or is under 2 years old, it's best to consult a doctor for guidance on the appropriate dose. Always follow these instructions carefully to ensure safe and effective use.

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 fatal, particularly if used in higher doses or for longer than recommended. If your child experiences severe or persistent sore throat, high fever, or symptoms of stomach bleeding (such as faintness, vomiting blood, or black stools), or shows signs of heart problems or stroke (like chest pain or weakness on one side of the body), seek medical attention immediately. Always consult a doctor before using 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 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 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 reach out for professional assistance. Your health and safety are the top priority.

Pregnancy Use

When considering the use of Children's Motrin (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, meaning there are no known reasons to avoid ibuprofen while pregnant, and no dosage adjustments are recommended for pregnant individuals.

However, since the insert does not provide special precautions, it's always best to consult with your healthcare provider before taking any medication during pregnancy. They can offer personalized advice based on your specific situation and health needs.

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, which means it could affect your nursing infant. Since the effects of ibuprofen on babies who are breastfed haven't been thoroughly studied, it's best to be cautious and seek professional advice 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 dosing guidelines carefully. For children under 2 years old, you should consult a doctor before use. For those aged 2 to 3 years, the recommended dose is 5 mL, while children aged 4 to 5 years should receive 7.5 mL. As your child grows, the dose increases: 10 mL for ages 6 to 8, 12.5 mL for ages 9 to 10, and 15 mL for 11-year-olds. Remember, do not exceed the recommended dose, and avoid using the medication for more than 2 days for sore throats, especially in children under 3 years old, unless directed by a doctor.

Be cautious if your child has a history of stomach issues, is dehydrated, or has certain health conditions like high blood pressure or asthma. It's best to consult a doctor if your child has had stomach bleeding problems or is taking other medications. If your child experiences no relief within 24 hours, if symptoms worsen, or if new symptoms appear, stop using the medication and seek medical advice. To help prevent stomach upset, consider giving the medication with food or milk.

Geriatric Use

While there is no specific information about the use of Children's MOTRIN (ibuprofen suspension) in older adults, it's important to approach its use with caution. Since the insert does not provide guidance on age considerations, dosage adjustments, or safety concerns for elderly patients, you should consult with a healthcare professional before using this medication. This is especially crucial if you or your loved one has any underlying health conditions or is taking other medications, as these factors can influence safety and effectiveness. Always prioritize open communication with your healthcare provider to ensure the best care.

Renal Impairment

If you have kidney problems, it's important to be aware of how this may affect your health and treatment. Conditions like high blood pressure, heart disease, liver cirrhosis, or a history of stroke can complicate your situation. Make sure to discuss your kidney health with your healthcare provider, as they may need to adjust your medication dosages or monitor your condition more closely.

Regular check-ups are essential to ensure that your kidneys are functioning well and to prevent any potential complications. Always inform your doctor about any changes in your health or new symptoms you experience, as this can help them provide the best care tailored to your needs.

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 your treatment.

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, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware of potential interactions when taking ibuprofen. If you or your child are 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 serious stomach bleeding increases. This risk is also heightened if your child is taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Before starting ibuprofen, make sure to discuss any other medications your child is taking with a healthcare provider, especially if they are on diuretics (medications that help remove excess fluid from the body). Open communication with your doctor can help ensure safe and effective treatment.

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). This helps maintain its quality and performance.

Before using the product, check that the carton tape or bottle wrap marked "Sealed For Your Safety" is intact. If you find it broken or missing, do not use the product, as this could indicate that it has been compromised. Always handle the product with care to ensure your safety and the best results.

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. If you experience stomach upset, it's advisable to take the medication with food or milk.

It's important to keep this medication out of reach of children. In the event 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 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. Use only the enclosed dosing cup and do not exceed the recommended dosage.

What are the common uses of Children's Motrin?

Children's Motrin relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, and it also reduces fever.

What should I do if my child has a severe sore throat?

If your child has a severe or persistent sore throat accompanied by high fever, headache, nausea, or vomiting, consult a doctor promptly.

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

Possible side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke. If your child experiences any severe symptoms, seek medical help immediately.

Can I give Children's Motrin to my child if they have had an allergic reaction to ibuprofen before?

No, 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, but it is advisable to consult a doctor.

What should I do if my child has high blood pressure or heart disease?

Consult a doctor before using Children's Motrin if your child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke.

How should I store Children's Motrin?

Store Children's Motrin between 20-25°C (68-77°F) and do not use it if the carton tape or bottle wrap is broken or missing.

What should I do in case of an overdose?

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

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 of the suspension 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 formulation is alcohol-free and is available in an original berry flavor. Each bottle contains 1 fluid ounce (30 mL) of the suspension. The National Drug Code (NDC) for this product is 50580-601-22.

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 dosage 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.

For patients weighing under 24 pounds or under 2 years of age, it is advised to consult a physician for the appropriate dosage. For patients weighing between 24 and 35 pounds (ages 2-3 years), the recommended dose is 5 mL. For those weighing 36 to 47 pounds (ages 4-5 years), the dose is 7.5 mL. Patients weighing 48 to 59 pounds (ages 6-8 years) should receive 10 mL, while those weighing 60 to 71 pounds (ages 9-10 years) should be administered 12.5 mL. Finally, for patients weighing 72 to 95 pounds (ages 11 years), the dose is 15 mL.

Dosing may be repeated every 6 to 8 hours as needed, but it is crucial not to exceed 4 doses in a 24-hour period. Healthcare professionals should ensure that patients do not receive more than the directed amount.

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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect 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 use increases the risk of gastrointestinal complications.

NSAIDs, excluding 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 symptoms indicative of potential 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 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, immediate medical attention is necessary. Caregivers should contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which is classified as a nonsteroidal anti-inflammatory drug (NSAID).

Severe allergic reactions can occur, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen carries a warning for potential severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems. The risk is heightened in those taking anticoagulants, steroid medications, or other NSAIDs, as well as in patients who exceed the recommended dosage or duration of treatment. Signs of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain.

Additionally, there is a significant risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. This risk increases with higher doses or prolonged use. Patients should be vigilant for symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Patients are advised to consult a healthcare professional if they experience a severe or persistent sore throat, particularly if accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. The use of ibuprofen should not exceed two days without medical guidance, especially in children under three years of age.

It is crucial to discontinue use and seek medical advice if any new symptoms arise, if fever or pain worsens or persists beyond three days, or if there is redness or swelling in the affected area.

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 recommended that patients consult a healthcare provider if they have a history of stomach issues, are experiencing dehydration, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Finally, patients should inform their healthcare provider if they are under treatment for any serious condition or are taking other medications, as these factors may influence the safety and efficacy of ibuprofen.

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 severe gastrointestinal bleeding. This risk is further amplified if the patient is also taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to 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 should not exceed the recommended dosage. The dosing chart is as follows:

  • Under 24 lbs / Under 2 years: Ask a doctor

  • 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

For sore throat, the product should not be used for more than 2 days or administered to children under 3 years of age unless directed by a doctor. Caution is advised due to the increased risk of stomach bleeding, particularly in children with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroids, or those using other NSAIDs.

Healthcare professionals should advise parents to consult a doctor before use if any of the following apply: the child has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma, or is taking a diuretic.

When administering this product, it is recommended to give it with food or milk if stomach upset occurs. Parents should be instructed to stop use and consult a doctor if the child does not experience relief within 24 hours, if fever or pain worsens or persists beyond 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Geriatric Use

There is no specific information regarding the use of Children's MOTRIN (ibuprofen suspension) in geriatric patients. The prescribing information does not provide recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects is advisable, as elderly patients may have altered pharmacokinetics and increased sensitivity to medications.

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 ibuprofen use during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. The text 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

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In particular, those with reduced kidney function, such as children with high blood pressure, heart disease, liver cirrhosis, or a history of stroke, should be evaluated for potential impacts on drug clearance. It is essential to assess renal function prior to initiating therapy and to monitor renal parameters regularly throughout treatment to ensure safety and efficacy. Adjustments to dosing may be necessary based on the degree of renal impairment to avoid adverse effects and optimize therapeutic outcomes.

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 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.

Regular assessment of liver function, including parameters such as serum aminotransferases, alkaline phosphatase, and bilirubin levels, is advised to ensure patient safety and therapeutic efficacy. If any significant changes in liver function are observed, reconsideration of the treatment regimen may be warranted.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the medication. Reports include gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis and various skin reactions. Additionally, serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been documented.

Cardiovascular events, including heart attack and stroke, have also been reported in association with the use of NSAIDs. Furthermore, instances of liver enzyme elevations and liver failure have been noted. Serious allergic reactions, including angioedema and anaphylaxis, have been observed in patients taking ibuprofen.

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.

It is essential to inform patients 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, patients should be cautioned against using this medication right before or after heart surgery.

Patients should be instructed to stop 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 stomach pain that does not improve. Furthermore, patients should be advised to 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.

Healthcare providers should emphasize 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, a doctor should be consulted. Patients should also be advised to seek medical advice if there is any redness or swelling in the painful area or if new symptoms arise.

When using this product, patients should be informed that it is advisable to take it with food or milk if stomach upset occurs. Additionally, healthcare providers should recommend consulting 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 discuss any history of serious side effects from pain relievers or fever reducers, as well as any issues with fluid intake, particularly if the child has lost a significant amount of fluid due to vomiting or diarrhea. It is also important to advise patients to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as if the child has asthma or is taking a diuretic.

Finally, healthcare providers should recommend that patients consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the packaging prior to use; the product should not be utilized if the carton tape or bottle wrap marked with "Sealed For Your Safety" is broken or missing, as this may indicate potential tampering or contamination. Proper handling and storage conditions are crucial to ensure the safety and effectiveness of the product.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 6-8 hours, not to exceed four doses per day. Patients are advised to take the medication with food or milk if they experience stomach upset. It is crucial to keep the medication out of reach of children, and in the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) is recommended.

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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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.