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Infants Ibuprofen

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Active ingredient
Ibuprofen 50 mg/1.25 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 2020
Label revision date
September 8, 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
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 2020
Label revision date
September 8, 2025
Manufacturer
Walgreens
Registration number
ANDA079058
NDC root
0363-5100
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

Ibuprofen is a concentrated oral suspension that belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is designed to help reduce fever and relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headaches, and toothaches. This medication is specifically intended for children aged 6 months to 23 months and comes in a pleasant berry flavor.

As a pain reliever and fever reducer, ibuprofen can provide relief for up to 8 hours. It is important to use the enclosed syringe for accurate dosing and to read all product information before use to ensure safety and effectiveness.

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 using this product, it's important to note that it does not come with complete directions or warnings for adult use. Always make sure to follow the recommended dosage and never give more than directed. To prepare the medication, shake the bottle well before use. You can find the right dose by referring to the dosing chart, which suggests using your child's weight for the most accurate measurement. If weight isn't available, you can use their age instead.

When measuring the dose, use the dosing device that comes with the product, as other devices may not provide accurate measurements. For administration, dispense the liquid 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 4 doses in a single day. For infants under 6 months, it's best to consult a doctor before giving any medication. For children weighing between 12 to 17 pounds (6 to 11 months old), the dose is 1.25 mL, and for those weighing 18 to 23 pounds (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 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, especially in individuals who are allergic to aspirin. Symptoms of a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication can lead to severe stomach bleeding, particularly in children with a history of stomach ulcers or bleeding issues, those taking blood thinners or steroids, or if used in higher doses or for longer than recommended.

There is also an increased risk of heart attack and stroke associated with NSAIDs like ibuprofen, especially if used excessively. If your child experiences severe or persistent sore throat, high fever, or other concerning symptoms, it’s important to consult a doctor. Be vigilant for signs of stomach bleeding, such as faintness, vomiting blood, or black stools, and seek medical attention if these occur. Always consult a healthcare professional before use if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

It's important to be aware of some serious warnings when using ibuprofen. If you or your child have a known allergy to aspirin, be cautious, as ibuprofen can cause severe allergic reactions. Symptoms may include hives, facial swelling, wheezing, or skin blisters. If any of these occur, stop using the medication and seek medical help immediately. Additionally, ibuprofen can lead to stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. The risk of heart attack and stroke also increases with ibuprofen use, particularly if taken in higher doses or for longer than recommended.

Before using ibuprofen, consult a doctor if your child has any history of stomach issues, is dehydrated, or has conditions like high blood pressure, heart disease, or asthma. If your child experiences severe sore throat symptoms, such as a high fever or persistent pain, seek medical advice promptly.

If you notice any signs of stomach bleeding, such as faintness, vomiting blood, or black stools, stop using ibuprofen and contact your doctor. Also, seek immediate medical help if there are symptoms of heart problems or stroke, like chest pain or weakness on one side of the body. If your child does not feel better within 24 hours, or if symptoms worsen or new ones appear, it's important to reach out to a healthcare professional.

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. Always prioritize your safety and the safety of others by acting quickly in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen during pregnancy has not been established. In fact, ibuprofen is not recommended, especially in the third trimester, because it may pose risks to your baby, including potential cardiovascular effects and complications during delivery.

Before taking ibuprofen or any medication, you should always consult your healthcare provider to discuss your options and ensure the safety of both you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there is no specific information available regarding the use of this medication for nursing mothers or during lactation (the period of breastfeeding). This means that the effects on breast milk and nursing infants are not clearly defined.

If you are breastfeeding or planning to breastfeed, it's always a good idea to consult with your healthcare provider about any medications you may be considering. They can help you understand any potential risks and make informed decisions that are best for you and your baby.

Pediatric Use

This product is suitable for children aged 6 months to 23 months. If your child is under 3 years old, you should only use it if directed by a doctor. For dosing, consult your doctor for children under 6 months. For those between 6 to 11 months and weighing 12 to 17 lbs, the dose is 1.25 mL, while children weighing 18 to 23 lbs (12 to 23 months) should receive 1.875 mL.

Be cautious, as there is a risk of stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs). Always consult a doctor before use if your child has any serious health issues, is dehydrated, or is taking other medications. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than 3 days, or if new symptoms arise, stop using the product and contact a doctor.

Geriatric Use

While the drug insert for Ibuprofen Oral Suspension does not provide specific information about its use in older adults, it mainly focuses on children aged 6 months to 23 months. This means there are no established guidelines, dosage adjustments, or safety concerns specifically for elderly patients mentioned in the insert.

If you are caring for an older adult, it's important to consult with a healthcare professional before using this medication. They can provide personalized advice and ensure that any treatment is safe and appropriate based on individual health needs.

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 whether any adjustments are needed based on your kidney function. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a 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 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.

Storage and Handling

To ensure the best results, store the product in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). Before using, make sure to shake the container well to mix the contents properly. It’s important to use only the dosing device that comes with the product; using any other device could lead to incorrect dosing.

For safety, keep the product out of reach of children. Additionally, check the packaging carefully: do not use the product if the carton is opened or if the printed foil under the cap is broken or missing, as this indicates that the product may have been tampered with. Following these guidelines will help ensure safe and effective use.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. If you experience stomach upset, it's advisable to take the medication with food or milk. Always 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 Ibuprofen?

Ibuprofen is a concentrated oral suspension (NSAID) used to reduce fever and relieve minor aches and pains in children ages 6 months to 23 months.

How does Ibuprofen work?

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

What are the dosing instructions for Ibuprofen?

For children 6 to 11 months weighing 12 to 17 lbs, the dose is 1.25 mL. For children 12 to 23 months weighing 18 to 23 lbs, the dose is 1.875 mL. Always use the enclosed dosing device.

What precautions should I take when using Ibuprofen?

Do not use Ibuprofen if your child has had an allergic reaction to pain relievers or fever reducers, or if they are undergoing heart surgery. Consult a doctor if your child has a history of stomach problems or is taking other medications.

What are the potential side effects of Ibuprofen?

Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack or stroke. If side effects occur, stop use and consult a doctor.

Can I use Ibuprofen during pregnancy?

The safety of Ibuprofen during pregnancy has not been established, and it is contraindicated, especially in the third trimester due to potential risks to the fetus.

What should I do in case of an overdose?

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

How should I store Ibuprofen?

Store Ibuprofen between 20° to 25°C (68° to 77°F) and keep it out of reach of children.

Is Ibuprofen safe for nursing mothers?

There is no specific information provided regarding the use of Ibuprofen in nursing mothers.

Packaging Info

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

Packaging configurations for Infants Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Infants Ibuprofen, 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

This product is intended for use in pediatric patients and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage administered does not exceed the recommended limits.

Prior to administration, the product must be shaken well. The appropriate dose can be determined using the dosing chart provided below. When possible, weight should be used to determine the dose; if weight is not available, age may be used as a guide.

Dosing should be measured using the dosing device provided; the use of any other device is not recommended. The liquid should be dispensed slowly into the child's mouth, directed toward the inner cheek. If necessary, doses may be repeated every 6 to 8 hours, but the total daily administration should not exceed 4 doses.

Dosing Chart:

  • For patients weighing under 6 lbs (less than 6 months of age): Consult a doctor for appropriate dosing.

  • For patients weighing 12 to 17 lbs (6 to 11 months of age): Administer 1.25 mL.

  • For patients weighing 18 to 23 lbs (12 to 23 months of age): Administer 1.875 mL.

Contraindications

Use is contraindicated in children with a history of allergic reactions to any 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 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 carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in children who have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or are exceeding the recommended dosage or duration of treatment.

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

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a healthcare provider promptly. The use of this medication should not exceed two days, nor should it be administered to children under three years of age unless directed by a physician.

Before administering ibuprofen, it is advisable to consult a healthcare professional if any of the following conditions apply: the child has a history of stomach problems (such as heartburn), has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, has asthma, or is taking a diuretic. Furthermore, consultation with a doctor or pharmacist is recommended if the child is under medical care for any serious condition or is taking other medications.

In the event of an allergic reaction, it is crucial to stop using the product and seek immediate medical help. In cases of overdose, medical assistance should be sought or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Discontinuation of ibuprofen and consultation with a healthcare provider is warranted if any side effects occur. Side effects can be reported to the FDA at 1-800-FDA-1088. Additionally, parents should 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. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also necessitate immediate medical attention. 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 arise, a healthcare provider should be contacted.

Side Effects

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

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this serious adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs, including aspirin and naproxen. Patients are advised to adhere strictly to dosing instructions, as exceeding the recommended dosage or duration of use increases the risk of stomach bleeding.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use the medication beyond the directed dosage or duration.

Common adverse reactions may include gastrointestinal symptoms, and patients should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention.

Patients should discontinue use and consult a healthcare provider if they do not achieve 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 arise.

Before using this product, it is essential for patients to consult a healthcare provider if they have a history of stomach problems, are experiencing dehydration, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Special caution is advised for patients under a doctor's care for serious conditions or those taking other medications.

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 Infants Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Infants Ibuprofen.
Details

Pediatric Use

This product is indicated for use in pediatric patients aged 6 months to 23 months. It is not recommended for children under 3 years of age unless directed by a healthcare professional.

Dosing Information:

  • For infants under 6 months, consultation with a doctor is required prior to use.

  • For children weighing 12 to 17 lbs (6 to 11 months), the recommended dose is 1.25 mL.

  • For those weighing 18 to 23 lbs (12 to 23 months), the recommended dose is 1.875 mL.

Safety Considerations: There is an increased risk of stomach bleeding in pediatric patients with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroids, or those using other NSAIDs. Prior to administration, it is essential to consult a healthcare provider if the child has a history of stomach issues, dehydration from vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, stroke, or asthma.

Additionally, consultation with a doctor or pharmacist is advised if the child is under medical care for any serious condition or is taking other medications.

Monitoring and Discontinuation: Parents or caregivers should discontinue use and seek medical advice if the child does not experience relief within 24 hours, if fever or pain worsens or persists beyond 3 days, or if any new symptoms arise.

Geriatric Use

The prescribing information for Ibuprofen Oral Suspension does not provide specific guidance regarding its use in geriatric patients. The focus of the insert is primarily on pediatric use, particularly for children aged 6 months to 23 months.

As there are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for elderly patients, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects, given the lack of specific data on this population.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to the risk of fetal harm. The use of ibuprofen during pregnancy may be associated with risks such as fetal cardiovascular effects and potential complications during delivery. Therefore, pregnant women should consult a healthcare provider before using ibuprofen to discuss potential risks and alternative treatment options.

Lactation

There is no specific information available regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication.

Renal Impairment

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

Hepatic Impairment

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

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests 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.

Healthcare providers should consider the overall health status of patients, including any coexisting conditions such as high blood pressure, heart disease, kidney disease, or a history of stroke, as these may further complicate the management of therapy in the context of hepatic impairment. Regular follow-up and reassessment of liver function are advised to ensure patient safety and therapeutic efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the specific clinical scenario presented.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs. Side effects may occur, and individuals are encouraged to report any adverse events to the FDA at 1-800-FDA-1088.

In cases where children exhibit signs of stomach bleeding, it is advised to discontinue use and consult a healthcare professional if any of the following symptoms occur: feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, if a child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling, it is recommended to stop use and seek medical attention.

Other considerations include discontinuing use 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 affected area, or if any new symptoms arise.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients that this medication should not be used if the child has a history of allergic reactions to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after heart surgery.

Patients must be instructed to stop use and consult a doctor if any side effects occur, and they may report side effects to the FDA at 1-800-FDA-1088. They should also be made aware of specific signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Furthermore, patients should be advised to stop use and seek medical attention if the child exhibits symptoms of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

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, they should consult a doctor. Patients should also be instructed 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 advised to take it with food or milk if stomach upset occurs. It is important for healthcare providers to ask patients if the stomach bleeding warning applies to their child and to recommend consulting a doctor before use if the child has a history of stomach problems, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers.

Patients should also be encouraged to consult a doctor before use if the child has not been drinking fluids, has lost a significant amount of fluid due to vomiting or diarrhea, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients should be advised to seek medical advice if the child has asthma, is taking a diuretic, or is under a doctor's care for any serious condition. Lastly, it is recommended that patients consult a doctor or pharmacist before use if the child is taking any other medications.

Storage and Handling

The product is supplied in a tamper-evident carton. It is essential to inspect the packaging before use; do not use if the carton is opened or if the printed foil under the cap is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20° to 25°C (68° to 77°F). Prior to administration, the product must be shaken well to ensure proper consistency. It is important to use only the enclosed dosing device for measurement; using any other device is not recommended. Additionally, the product should be kept out of reach of children to ensure safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6 to 8 hours as needed, 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. In the event of an overdose, patients should seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

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

Drug Information (PDF)

This file contains official product information for Infants Ibuprofen, 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 Ibuprofen, 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

Last AI update:

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.