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Childrens Motrin

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Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
October 8, 2025
Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
October 8, 2025
Manufacturer
Kenvue Brands LLC
Registration number
ANDA076359
NDC root
50580-933

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Drug Overview

Children's Motrin® is a chewable tablet containing ibuprofen (a type of medication that helps reduce pain and inflammation) in a 100 mg dosage. It is designed for children aged 2 to 11 years and serves as a pain reliever and fever reducer. This medication can help alleviate minor aches and pains associated with common conditions such as colds, flu, sore throats, headaches, and toothaches.

The effects of Children's Motrin® can last up to 8 hours, providing relief when your child needs it most. The tablets are grape-flavored and can be chewed or crushed before swallowing, making them easier for children to take.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It’s effective for discomfort caused by common conditions such as the cold, flu, sore throat, headaches, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

Before taking this medication, make sure to chew or crush the tablets completely before swallowing them. It's important to follow the dosage instructions carefully, so do not take more than what is directed. To find the right dose for you or your child, refer to the dosing chart based on weight or age. If you can, use weight for a more accurate dose; otherwise, age can be used.

If you need to take another dose, you can repeat it every 6 to 8 hours, but remember not to exceed four doses in a single day. For specific dosing based on weight and age: if your child weighs under 24 pounds or is under 2 years old, consult a doctor first. For children weighing between 24 to 35 pounds and aged 2 to 3 years, the dose is 1 tablet. For those weighing 36 to 47 pounds and aged 4 to 5 years, the dose is 1 ½ tablets. If your child weighs 48 to 59 pounds and is aged 6 to 8 years, they should take 2 tablets. For children weighing 60 to 71 pounds and aged 9 to 10 years, the dose is 2 ½ tablets, and for an 11-year-old weighing 72 to 95 pounds, the dose is 3 tablets. Always ensure you are following these guidelines for 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. Signs of a severe allergic reaction 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, bloody or black stools, chest pain, difficulty breathing, or weakness on one side of the body, 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 use ibuprofen as directed and consult a healthcare professional if you have any concerns.

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 issues, 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, stop use and contact your doctor right away.

If you or your child has a severe sore throat that lasts more than two days or is accompanied by high fever, headache, nausea, or vomiting, consult a doctor. For any overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Always consult your doctor if symptoms worsen or new symptoms appear.

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.

Don’t wait to see if symptoms improve; getting prompt assistance can be vital for your safety. Always err on the side of caution and reach out for help if you think an overdose has occurred.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with medications. The information available does not provide specific guidance on the use of Children's Motrin (ibuprofen) during pregnancy, including safety concerns, dosage adjustments, or any special precautions.

Given this lack of information, it's best to consult your healthcare provider before taking Children's Motrin or any medication while pregnant. They can help you understand the potential risks and benefits based on your individual 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 ibuprofen may pass into your breast milk, which could pose some risks to your baby. Therefore, you should exercise caution when considering ibuprofen while nursing. Always prioritize your health and your infant's safety by seeking professional advice.

Pediatric Use

When considering this medication for your child aged 2 to 11 years, it's important to follow specific dosing guidelines based on their weight. For children weighing under 24 pounds and those under 2 years old, you should consult a doctor before use. For children aged 2 to 3 years who weigh between 24-35 pounds, the recommended dose is 1 tablet. As your child grows, the dosage increases: 1 ½ tablets for ages 4-5 years (36-47 pounds), 2 tablets for ages 6-8 years (48-59 pounds), 2 ½ tablets for ages 9-10 years (60-71 pounds), and 3 tablets for an 11-year-old weighing 72-95 pounds.

It's crucial not to use this medication for more than 2 days or to give it to children under 3 years old without a doctor's guidance. Additionally, if your child has a history of stomach issues, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers, consult a doctor before use. Always check with a healthcare professional if your child is under treatment for a serious condition or is taking other medications.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 doctor will help determine if this medication is safe for you and may suggest specific guidelines or adjustments based on your kidney health. Always prioritize open communication with your healthcare provider to ensure your safety and well-being.

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 have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care for your health.

Storage and Handling

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

When handling the product, be sure to do so with care to avoid any damage. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or other safety measures, please refer to the guidelines provided with your product.

Additional Information

You should take this medication orally, making sure to chew or crush the tablets completely before swallowing. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. To help prevent any burning sensation in your mouth or throat, consider taking the medication with food or water. If you experience an upset stomach, taking it with food or milk may also help.

FAQ

What is Children's Motrin?

Children's Motrin is an ibuprofen chewable tablet, available in 100 mg, 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 administer Children's Motrin?

You should chew or crush the tablets completely before swallowing. If needed, you can repeat the dose every 6-8 hours, but do not exceed 4 doses in a day.

What are the indications for using Children's Motrin?

Children's Motrin reduces fever and relieves minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

Are there any contraindications for Children's Motrin?

Do not use Children's Motrin if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer, or if they are about to undergo heart surgery.

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. Consult a doctor if your child experiences any severe symptoms.

How should I store Children's Motrin?

Store Children's Motrin between 20-25°C (68-77°F).

Can I use Children's Motrin during pregnancy?

There is no specific information regarding the use of Children's Motrin during pregnancy, so consult a doctor before use.

Is it safe to use Children's Motrin while breastfeeding?

Nursing mothers should consult a doctor before using Children's Motrin due to the potential for ibuprofen to be excreted in breast milk.

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

No description information is available for the drug.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

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

Dosage and Administration

Tablets should be chewed or crushed completely before swallowing. Healthcare professionals are advised to ensure that patients do not exceed the recommended dosage. The appropriate dose can be determined using the following chart, prioritizing weight for dosing when possible; otherwise, age may be used.

For patients weighing less than 24 pounds or under 2 years of age, consultation with a physician is recommended prior to administration. For patients weighing between 24 to 35 pounds or aged 2 to 3 years, the recommended dose is 1 tablet. For those weighing 36 to 47 pounds or aged 4 to 5 years, the dosage increases to 1 ½ tablets. Patients weighing 48 to 59 pounds or aged 6 to 8 years should receive 2 tablets. For individuals weighing 60 to 71 pounds or aged 9 to 10 years, the appropriate dose is 2 ½ tablets. Finally, for patients weighing between 72 to 95 pounds or aged 11 years, the recommended dosage is 3 tablets.

If necessary, doses may be repeated every 6 to 8 hours, but it is imperative not to exceed 4 doses in a 24-hour period.

Contraindications

Use is contraindicated in patients with 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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can 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 an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is linked to 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 extended periods.

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. 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.

In the event of an overdose, immediate medical attention is required. Healthcare professionals should advise caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Healthcare providers should instruct caregivers to discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms indicative of heart problems or stroke, including 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 consultation is advised. Caregivers should also be vigilant for the emergence of any new symptoms and seek guidance accordingly.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which can vary in seriousness and frequency.

Severe allergic reactions have been reported, 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, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential risk of severe stomach bleeding. This risk 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, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

There is also a significant warning regarding 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 when the medication is used inappropriately, such as exceeding the recommended dosage or duration of treatment.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical attention promptly if these symptoms occur.

In the event of potential stomach bleeding, patients should discontinue use and consult a healthcare provider if they experience symptoms such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Additionally, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

Other adverse reactions may include mouth or throat burning, which can be mitigated by administering the medication with food or water. It is advisable to take ibuprofen with food or milk to reduce the likelihood of stomach upset.

Patients should not use ibuprofen if they have a history of allergic reactions to the drug or any other pain reliever/fever reducer, and it is contraindicated for use immediately before or after heart surgery.

Before initiating treatment, it is recommended that patients consult a healthcare provider if any of the following conditions apply: a history of stomach bleeding, previous serious side effects from pain relievers, dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, stroke history, asthma, or if they are taking diuretics. Furthermore, patients under a doctor's care for serious conditions or those taking other medications should seek advice from a healthcare professional or pharmacist prior to use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 be administered the medication according to the following dosing chart based on weight:

  • For patients weighing under 24 lb (age under 2 years), consultation with a doctor is required.

  • For patients weighing 24-35 lb (ages 2-3 years), the recommended dose is 1 tablet.

  • For patients weighing 36-47 lb (ages 4-5 years), the recommended dose is 1 ½ tablets.

  • For patients weighing 48-59 lb (ages 6-8 years), the recommended dose is 2 tablets.

  • For patients weighing 60-71 lb (ages 9-10 years), the recommended dose is 2 ½ tablets.

  • For patients weighing 72-95 lb (age 11 years), the recommended dose is 3 tablets.

It is important to note that the medication should not be used for more than 2 days or administered to children under 3 years of age unless directed by a doctor. Prior to use, consultation with a healthcare professional is advised if the child has a history of stomach problems, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers. Additionally, a doctor should be consulted if the child is under medical care for any serious condition or is taking any other medications.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific mention of the use of Children's Motrin (ibuprofen) during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data regarding the use of ibuprofen in pregnant patients when making treatment decisions. Given the potential risks associated with nonsteroidal anti-inflammatory drugs (NSAIDs) during pregnancy, particularly in the third trimester, it is advisable to weigh the benefits against potential fetal risks. Women of childbearing potential should be counseled on the importance of discussing any medication use with their healthcare provider during pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion of ibuprofen in breast milk. Caution is advised when administering ibuprofen to nursing mothers due to the potential risk to the infant.

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. It is essential to assess liver function prior to initiating treatment. In patients with liver cirrhosis, dosage adjustments may be necessary, and close monitoring of liver function is recommended throughout the treatment course.

Patients with significant hepatic impairment should be evaluated for potential contraindications, particularly if they have comorbid conditions such as high blood pressure, heart disease, kidney disease, or a history of stroke. Regular monitoring of liver enzymes and other relevant laboratory parameters is advised to ensure patient safety and therapeutic efficacy.

Healthcare providers should exercise caution when prescribing this medication to patients with compromised liver function and consider alternative therapies if necessary.

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 potential 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.

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve activated charcoal administration, intravenous fluids, or other interventions based on the clinical presentation.

It is essential to document the details of the overdose, including the substance, amount ingested, time of ingestion, and any symptoms observed, to facilitate appropriate treatment and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information regarding animal pharmacology and toxicology.

Postmarketing Experience

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

Cardiovascular events, including myocardial infarction and stroke, have also been documented in association with the use of NSAIDs. Furthermore, liver enzyme elevations and instances of hepatitis have been noted. Reports of asthma exacerbations in patients with pre-existing asthma have been observed as well.

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 help immediately or contact a Poison Control Center 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 avoid use right before or after heart surgery.

Healthcare providers should instruct patients 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 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 to discontinue use and consult a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists for more than three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, patients may experience mouth or throat burning; therefore, it is recommended to administer it with food or water. If stomach upset occurs, taking the medication with food or milk may help alleviate discomfort.

Healthcare providers should encourage patients to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies. It is also essential to ask a doctor 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.

Patients should be advised to seek medical advice if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, it is important to consult a doctor before use if the child has asthma, is taking a diuretic, or is under a doctor's care for any serious condition. Lastly, patients should be encouraged to discuss any other medications the child is taking with a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered orally, with tablets recommended to be chewed or crushed completely before swallowing. Dosing may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period.

Clinicians should counsel patients that mouth or throat burning may occur, and it is advisable to take the medication with food or water to mitigate this effect. If stomach upset occurs, taking the medication with food or milk is recommended. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.