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Infants Motrin

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Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2004
Label revision date
January 16, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
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 2004
Label revision date
January 16, 2025
Manufacturer
Kenvue Brands LLC
Registration number
NDA020603
NDC root
50580-100
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Motrin is a medication that contains ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID). It is designed for infants aged 6 months to 23 months and is used to reduce fever and relieve minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches. The concentrated drops come in a pleasant berry flavor and can provide relief for up to 8 hours.

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.

Feel free to rely on this treatment when you're feeling under the weather, as it can help make you more comfortable during your recovery.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never give more than directed. To prepare the medication, shake the bottle well before use.

To find the right dose for your child, refer to the dosing chart. If possible, use your child's weight for the most accurate measurement; otherwise, you can use their age. For measuring, use the dosing device that comes with the product—do not use any other device. When giving the liquid, dispense it slowly into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day.

For children under 6 months, it's best to consult a doctor before administering this medication. For children weighing between 12 to 17 pounds (approximately 6 to 11 months old), the dose is 1.25 mL, and for those weighing 18 to 23 pounds (around 12 to 23 months old), the dose is 1.875 mL.

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 fatal, particularly if used in higher doses or for longer than recommended. If your child experiences symptoms such as faintness, vomiting blood, black or bloody 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 check with a healthcare professional before using ibuprofen, especially 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 ibuprofen 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 using ibuprofen 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.

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

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns mentioned. This means that there is no detailed information available about how the medication may affect you or your baby, including whether any dosage adjustments or special precautions are necessary.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider. They can help you understand the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant while you are breastfeeding. Always consult with your healthcare provider if you have any concerns or questions about using medications while nursing.

Pediatric Use

It's important to be cautious when using this medication for children. You should avoid giving it to children under 3 years old unless a doctor specifically advises it for a sore throat that comes with a high fever, headache, nausea, or vomiting. For younger children, the dosage varies: if your child is under 6 months, consult a doctor first. For those between 6 to 11 months and weighing 12-17 lbs, the recommended dose is 1.25 mL, while children weighing 18-23 lbs (12-23 months) should receive 1.875 mL.

Always consult a doctor if your child has a history of stomach issues, is not drinking enough fluids, has lost fluids from vomiting or diarrhea, or has conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. When giving this medication, it's best to do so with food or milk to prevent stomach upset. If your child doesn't feel better within 24 hours, if their fever or pain worsens or lasts more than 3 days, if you notice redness or swelling in the painful area, or if any new symptoms arise, stop using the medication and consult a doctor.

Geriatric Use

While there is no specific information about the use of Infants' Motrin (ibuprofen suspension/drops) in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before using this medication. They can help determine if it’s appropriate for you or your loved one, especially considering any existing health conditions or medications that may interact with ibuprofen. Always prioritize safety and seek professional advice when it comes to medication use in older adults.

Renal Impairment

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

Hepatic Impairment

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

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

Drug Interactions

It's important to be aware of potential interactions when taking ibuprofen. If you or your child are allergic to aspirin, using ibuprofen could lead to severe allergic reactions. Additionally, if your child is on blood thinners (medications that help 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.

Always consult with a 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 safety and avoid any harmful interactions.

Storage and Handling

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

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 may indicate that it has been compromised. Following these guidelines will help you use the product safely and effectively.

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 for assistance.

FAQ

What is Motrin?

Motrin is a concentrated ibuprofen oral suspension (NSAID) used as a pain reliever and fever reducer for infants.

What age group is Motrin suitable for?

Motrin is suitable for children aged 6 months to 23 months.

How does Motrin work?

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

What is the recommended dosage for Motrin?

For children 12-17 lbs (6-11 months), the dosage is 1.25 mL, and for 18-23 lbs (12-23 months), it is 1.875 mL. Always consult a doctor for children under 6 months.

What should I do if my child has an allergic reaction to Motrin?

If your child experiences symptoms like hives, facial swelling, or difficulty breathing, stop use immediately and seek medical help.

What are the warnings associated with Motrin?

Motrin may cause severe stomach bleeding, increase the risk of heart attack and stroke, and should not be used if the child has had an allergic reaction to ibuprofen.

How should Motrin be administered?

Shake well before using and measure with the dosing device provided. Dispense the liquid slowly into the child's mouth, toward the inner cheek.

What should I do if my child does not get relief from Motrin?

If your child does not experience relief within the first 24 hours, or if fever or pain worsens or lasts more than 3 days, consult a doctor.

Is there any specific information regarding Motrin use during pregnancy or breastfeeding?

There is no specific information provided regarding the use of Motrin during pregnancy or breastfeeding.

How should Motrin be stored?

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

Packaging Info

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

Packaging configurations for Infants Motrin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Concentrated Motrin® Infants' Drops is an ibuprofen oral suspension formulated for infants aged 6 months to 23 months. Each 1.25 mL dose contains 50 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) recognized for its pain-relieving and fever-reducing properties. The product is packaged in a 1/2 fl oz (15 mL) bottle and is designed to provide relief for up to 8 hours. It is available in an original berry flavor and is intended for use with the enclosed syringe for accurate dosing. The National Drug Code (NDC) for this formulation is 50580-100-18.

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

This product is intended for pediatric use only, and healthcare professionals should ensure that dosing is based on the child's weight whenever possible. If weight is not available, age may be used as a guide.

Prior to administration, the product must be shaken well. The appropriate dose should be measured using the dosing device provided; no other measuring device should be utilized to ensure accuracy. The liquid should be dispensed slowly into the child's mouth, directed toward the inner cheek to facilitate swallowing.

The following dosing chart provides guidance for administration:

  • For infants under 6 months of age, consultation with a physician is required before use.

  • For infants weighing between 12 to 17 pounds (6 to 11 months), the recommended dose is 1.25 mL.

  • For infants weighing between 18 to 23 pounds (12 to 23 months), the recommended dose is 1.875 mL.

Doses may be repeated every 6 to 8 hours as needed, but it is imperative not to exceed 4 doses in a 24-hour period. Healthcare professionals should advise caregivers to adhere strictly to these guidelines and not to exceed the recommended dosage.

Contraindications

Use is contraindicated in patients who have a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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 the 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 increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with the use of higher doses or prolonged treatment.

In cases of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. Ibuprofen should not be used for more than two days or administered to children under three years of age unless directed by a physician.

In the event of an overdose, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Healthcare providers should instruct caregivers to discontinue use and consult a physician 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, if symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—medical attention should be sought without delay.

Furthermore, if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms develop, it is essential to seek medical advice.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in severity.

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 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, steroids, or other NSAIDs, as well as in patients who exceed the recommended dosage or duration of use. Signs of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain.

Additionally, ibuprofen is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess or for prolonged periods.

Patients should be vigilant for severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical advice promptly. It is advised not to use ibuprofen for more than two days in cases of sore throat or to administer it to children under three years of age without a doctor's guidance.

If a child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical consultation is recommended. Additional signs warranting immediate medical attention include redness or swelling in the painful area and the appearance of any new symptoms.

It is crucial to avoid the use of ibuprofen in children with a history of allergic reactions to the drug or other pain relievers/fever reducers, and it should not be administered immediately before or after heart surgery. Prior to use, consultation with a healthcare provider is advised if the child has a history of stomach problems, has not been adequately hydrated, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, caution is warranted if the child is taking diuretics or is under medical care for any serious condition.

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 severe gastrointestinal bleeding. Therefore, it is imperative to monitor these patients closely and consider alternative pain management strategies if necessary.

Additionally, the risk of severe stomach bleeding is elevated when ibuprofen is used in conjunction with 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 to ensure safe and effective use.

Packaging & NDC

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

Packaging configurations for Infants Motrin.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this product unless directed by a healthcare professional for sore throat accompanied by high fever, headache, nausea, and vomiting.

For dosing, the following guidelines apply:

  • Infants under 6 months: Consult a doctor.

  • Infants weighing 12-17 lbs (6-11 months): Administer 1.25 mL.

  • Infants weighing 18-23 lbs (12-23 months): Administer 1.875 mL.

Healthcare professionals should exercise caution and consult a doctor if the pediatric patient has a history of stomach problems, is not adequately hydrated, has experienced significant fluid loss due to vomiting or diarrhea, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

When using this product, it is advisable to take it with food or milk to mitigate potential stomach upset.

Parents or caregivers should discontinue use and seek medical advice if the child does not experience relief within the first 24 hours, if fever or pain worsens or persists beyond 3 days, if there is redness or swelling in the affected area, or if any new symptoms arise.

Geriatric Use

There is no specific information regarding the use of Infants' Motrin (ibuprofen suspension/drops) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful clinical judgment. Monitoring for potential adverse effects may be warranted in this population.

Pregnancy

There is no specific mention of pregnancy use, safety concerns, dosage modifications, or special precautions regarding the use of this medication during pregnancy. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the absence of established safety information and the importance of discussing any plans for pregnancy with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants while using this product.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for potential contraindications or the need for alternative therapeutic strategies. Regular follow-up assessments are advised to monitor any changes in liver function that may impact treatment decisions.

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 help 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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, cases of 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 bronchospasm, 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 also inform patients 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 beyond three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

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

Patients should also 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 before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke, as well as if the child has asthma or is taking a diuretic.

Finally, patients should be reminded to consult a doctor or pharmacist before use if the child is under a doctor's 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 compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial for ensuring the product's quality and effectiveness.

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 Infants 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 Infants 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.