Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Infants Ibuprofen

Last content change checked dailysee data sync status

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 2025
Label revision date
July 21, 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 2025
Label revision date
July 21, 2025
Manufacturer
Safeway
Registration number
ANDA075217
NDC root
21130-513
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

Infants’ Ibuprofen is an oral suspension designed for infants aged 6 months to 23 months, providing a berry-flavored option for parents. This medication acts as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). It helps reduce fever and relieve minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches.

The formulation is concentrated, non-staining, dye-free, and gluten-free, making it a suitable choice for young children. Infants’ Ibuprofen can provide relief for up to 8 hours, ensuring your little one feels more comfortable during times of discomfort.

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 like the cold, flu, sore throat, headaches, and toothaches.

Feel free to take it when you're feeling under the weather, as it can help make you more comfortable during those times.

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 four doses in a single day. For infants under 6 months, it's best to consult a doctor before giving any medication.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

Always prioritize your child's safety by following these guidelines closely. If you have any concerns or questions about using this medication, consult with a healthcare professional for personalized advice.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences severe or persistent sore throat, high fever, or symptoms of stomach bleeding (such as faintness, vomiting blood, or black stools), seek medical attention immediately. Always consult a doctor if your child has a history of stomach issues, is dehydrated, or has other serious health conditions before using ibuprofen.

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 immediately and seek medical help.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without consulting a doctor, especially if they are under three years old. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

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

Pregnancy Use

It’s important to be cautious about using ibuprofen during pregnancy, as its safety has not been established. Specifically, ibuprofen is not recommended during the third trimester (the final three months of pregnancy) due to potential risks to your baby, including possible cardiovascular effects.

If you are pregnant or planning to become pregnant, it’s essential to talk to your healthcare provider before taking ibuprofen or any medication. They can help you understand the risks and suggest safer alternatives if needed.

Lactation Use

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

If you do take ibuprofen while nursing, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help you weigh the benefits and risks to ensure both you and your infant stay healthy.

Pediatric Use

It's important to be cautious when using this medication in children. You should not give it to children under 3 years of age unless a doctor specifically advises you to do so. For children aged 6 months to 23 months, the dosage varies based on their weight, so it's best to consult your doctor for guidance, especially for those under 6 months.

Always check with a doctor if your child has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, or has not been drinking enough fluids due to vomiting or diarrhea. Additionally, consult a doctor if your child has any serious health conditions, such as high blood pressure, heart disease, or asthma, or if they are taking other medications. If your child shows any signs of stomach bleeding, heart problems, or if they do not feel better within 24 hours, stop using the medication and seek medical advice immediately.

Geriatric Use

When it comes to using this product for older adults, there is no specific information available about its safety or effectiveness. This means that if you or a loved one is considering this medication, it’s important to consult with a healthcare provider who can provide personalized advice based on individual health needs.

Additionally, since the product lacks complete directions and warnings for adult use, you should be particularly cautious. Always discuss any existing health conditions or medications with your doctor to ensure that this product is appropriate for you or your loved one. Your healthcare provider can help you understand any potential risks and make informed decisions about treatment options.

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 adjustments to your dosage or additional monitoring to ensure your health and safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any other medical conditions you may have.

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 medications like 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 prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if they are 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 potential interactions with your doctor is crucial to ensure safety and effectiveness in treatment.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). It's important to avoid freezing the product, as this can damage it. Before use, check the printed neckband; do not use the product if it is broken or missing, as this could compromise safety.

By following these simple storage and handling guidelines, you can help maintain the integrity of the product and ensure its effectiveness.

Additional Information

You should take this medication orally, dispensing the liquid slowly into your child's mouth toward the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. To help prevent stomach upset, consider giving it 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 Infants’ Ibuprofen used for?

Infants’ Ibuprofen is used to reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What is the recommended dosage for Infants’ Ibuprofen?

For infants aged 6-11 months weighing 12-17 lbs, the dose is 1.25 mL. For those aged 12-23 months weighing 18-23 lbs, the dose is 1.875 mL.

How should I administer Infants’ Ibuprofen?

Use the enclosed syringe to measure the dose and dispense the liquid slowly into the child’s mouth, toward the inner cheek. Shake well before using.

Are there any warnings associated with Infants’ Ibuprofen?

Yes, it may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

Can I use Infants’ Ibuprofen if my child has allergies?

Do not use Infants’ Ibuprofen if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

Is it safe to use Infants’ Ibuprofen during pregnancy?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated, especially during the third trimester.

What should I do if my child experiences side effects?

Stop use and consult a doctor if your child shows signs of stomach bleeding, heart problems, or does not get relief within 24 hours.

How should I store Infants’ Ibuprofen?

Store Infants’ Ibuprofen at 20-25°C (68-77°F) and do not freeze. Ensure the printed neckband is intact before use.

Can nursing mothers use Infants’ Ibuprofen?

Nursing mothers should consult a doctor before using this product, as ibuprofen may be excreted in breast milk.

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

Infants’ Ibuprofen is an oral suspension formulated as a concentrated drop, providing 50 mg of ibuprofen per 1.25 mL. This non-steroidal anti-inflammatory drug (NSAID) serves as a pain reliever and fever reducer. The product is presented in a 1 fluid ounce (30 mL) bottle and features a berry flavor. It is designed to be non-staining, dye-free, and gluten-free, with no high fructose corn syrup included. The effects of the medication can last up to 8 hours. Administration should be conducted using the enclosed syringe.

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 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 should be determined using the dosing chart provided below, with weight being the preferred method for dosing. If weight is not available, age may be used as an alternative.

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 to facilitate swallowing.

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

Dosing Chart:

  • For children weighing under 6 lbs and aged under 6 months, consult a physician before administration.

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

  • For children weighing 18-23 lbs (ages 12-23 months), the recommended dose is 1.875 mL.

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, or 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.

Healthcare providers should advise caregivers to discontinue use and seek medical attention 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—immediate medical evaluation is warranted.

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, further medical consultation is necessary. Any new symptoms that develop should also prompt a discussion with a healthcare professional.

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

Side Effects

Patients may experience a range of adverse reactions associated with the use of 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 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. Patients should be monitored for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

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 exceed the recommended dosage or duration of use. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention.

Common adverse reactions may include sore throat, especially if severe or persistent, or accompanied by high fever, headache, nausea, and vomiting. Patients are advised to consult a healthcare provider if symptoms do not improve within 24 hours or if fever or pain worsens or persists beyond three days.

Patients should also be cautioned to seek medical advice before using this product if they have a history of stomach problems, are dehydrated, or have underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, it is recommended that patients under a doctor's care for serious conditions or those taking other medications consult with a healthcare professional prior to use.

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 terms of pharmacodynamic interactions, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. This risk is further compounded when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Clinicians should exercise caution and consider alternative therapies or enhanced monitoring for patients requiring these combinations.

Additionally, it is advisable to consult a healthcare professional if the patient is concurrently using a diuretic. This consultation is important to evaluate potential interactions and to determine the need for dosage adjustments or increased monitoring of renal function and fluid status.

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

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. For dosing in children aged 6 months to 23 months, the following guidelines apply based on weight: for those under 6 months, consultation with a doctor is advised; for children weighing 12-17 lbs (6-11 months), the recommended dose is 1.25 mL; and for those weighing 18-23 lbs (12-23 months), the dose is 1.875 mL.

Healthcare professionals should be consulted if the pediatric patient has a history of stomach issues, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers. Additionally, consultation is necessary if the child has not been adequately hydrated due to vomiting or diarrhea, or if there are pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

It is also important to seek medical advice if the child is taking a diuretic, is under care for any serious condition, or is using any other medications. Parents or caregivers should discontinue use and consult a doctor if the child shows signs of stomach bleeding, symptoms indicative of heart problems or stroke, or if there is no relief within the first 24 hours of treatment.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. Additionally, the absence of directions or complete warnings for adult use suggests that caution should be exercised when considering this product for geriatric patients.

Healthcare providers are advised to carefully evaluate the potential risks and benefits when prescribing this product to elderly patients, taking into account the lack of established safety and efficacy data in this population. Monitoring for adverse effects and adjusting dosages as necessary may be prudent in the management of geriatric patients.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during this period may pose risks, including potential cardiovascular effects on the developing fetus.

Pregnant women are advised to consult a healthcare provider before using ibuprofen to discuss potential risks and alternative treatment options.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

Renal Impairment

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

Hepatic Impairment

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

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment course.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. It is crucial to consider the overall health status of these patients, including any coexisting conditions such as high blood pressure, heart disease, kidney disease, or a history of stroke, as these may further complicate their treatment regimen.

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

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. 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 may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of ongoing safety monitoring.

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 recommended to administer the medication with food or milk if the child experiences stomach upset.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, healthcare providers should inform patients to stop use and seek medical attention if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should be counseled to monitor the child’s response to treatment. If the child does not experience relief within the first 24 hours, or if fever or pain worsens or persists beyond three days, they should contact a healthcare professional. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a consultation with a doctor.

Before initiating treatment, healthcare providers should encourage patients to discuss the following with their doctor: if the stomach bleeding warning applies to the child, if the child has a history of stomach issues such as heartburn, if there have been any serious side effects from pain relievers or fever reducers, if the child has not been adequately hydrated, or if there has been significant fluid loss due to vomiting or diarrhea. It is also important to consider the child’s medical history, including high blood pressure, heart disease, liver cirrhosis, kidney disease, stroke, asthma, or if the child is taking a diuretic.

Lastly, patients should be advised to consult a doctor or pharmacist before use if the child is currently under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use. The product should not be utilized if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial to ensure the product's quality and effectiveness.

Additional Clinical Information

The medication is administered orally, with clinicians advised to dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek. If necessary, the dose may be repeated every 6 to 8 hours, but should not exceed four doses in a 24-hour period.

Patients should be counseled to administer the medication with food or milk if stomach upset occurs and to keep it out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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.