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Concentrated Ibuprofen Infants

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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 2023
Label revision date
November 3, 2023
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 2023
Label revision date
November 3, 2023
Manufacturer
Chain Drug Marketing Association Inc.
Registration number
ANDA210755
NDC root
83324-005
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 a concentrated oral suspension designed specifically for infants aged 6 to 23 months. It serves as a pain reliever and fever reducer, helping to alleviate minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches. This medication is a type of nonsteroidal anti-inflammatory drug (NSAID) that can provide relief for up to 8 hours and comes in a pleasant mixed berry flavor.

When using Infants' Ibuprofen, you can feel confident knowing that it is alcohol-free and dye-free, making it a suitable choice for your little one. Always use the enclosed syringe for accurate dosing to ensure your child receives the correct amount.

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 specific 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 each 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 provided with the product—do not use any other measuring tools. 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 4 doses in a single day.

For children under 6 months, it's best to consult a doctor before administering this medication. For children aged 6 to 23 months, the recommended doses are 1.25 mL for those weighing 12-17 lbs and 1.875 mL for those weighing 18-23 lbs.

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.

Be aware that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Dependence (a condition where the body becomes reliant on a substance) can also occur, so it's crucial to follow these guidelines closely to ensure your child's safety.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, especially in those allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), and skin rashes. Additionally, this medication can lead to severe stomach bleeding, particularly in children with a history of stomach ulcers or those taking blood thinners or other NSAIDs. There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening if used improperly.

You should stop using ibuprofen and consult a doctor if your child experiences signs of stomach bleeding, such as faintness, vomiting blood, or black stools. Seek medical attention if they show symptoms of heart problems or stroke, like chest pain or weakness on one side of the body. It's important to monitor your child closely and consult a healthcare professional if their symptoms worsen or do not improve within a few days. Always talk to a doctor before giving ibuprofen if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in individuals who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or any skin rash, stop using the medication immediately and seek medical help. Additionally, be aware that ibuprofen can lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, especially if used in higher doses or for longer than recommended. If your child has a severe or persistent sore throat, especially with high fever, headache, nausea, or vomiting, consult a doctor right away. It’s important not to use ibuprofen for more than two days in children under three years old unless directed by a healthcare professional.

If you suspect an overdose, contact a Poison Control Center or seek emergency medical help immediately. You should also stop using ibuprofen and call your doctor if your child experiences symptoms of stomach bleeding (like faintness, vomiting blood, or black stools), signs of heart problems or stroke (such as chest pain or trouble breathing), or if their condition does not improve within 24 hours. Additionally, seek medical advice if fever or pain worsens after three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any particular guidelines or risks associated with its use. There are no stated contraindications (conditions that would make the use of a drug inadvisable) or special precautions for pregnant individuals. Additionally, the insert does not provide any recommendations for dosage modifications for those who are pregnant.

While the absence of warnings may seem reassuring, it's always best to consult with your healthcare provider before taking any medication during pregnancy. They can offer personalized advice based on your specific situation and health needs.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, which means it could affect your nursing infant. Since the effects of ibuprofen on babies who are breastfed haven't been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by seeking professional advice.

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 you to do so. For younger children, the dosage varies: if your child is under 6 months, consult a doctor first. For those between 6 to 23 months, the recommended doses are 1.25 mL for those weighing 12-17 lbs and 1.875 mL for those weighing 18-23 lbs.

Always check with a doctor if your child has a history of stomach issues, is on other medications, or has lost a lot of fluids from vomiting or diarrhea. If you notice any signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the medication and consult a doctor immediately. To help prevent stomach upset, give the medication with food or milk, and remember not to exceed the recommended dosage of 4 doses in a day.

Geriatric Use

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

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to be aware of potential interactions when your child is taking medications. For instance, if your child is using ibuprofen, it can increase the risk of severe stomach bleeding, particularly if they are also taking blood thinners (medications that prevent blood clots) or steroids. Additionally, combining ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen can further elevate this risk.

Always discuss any medications your child is taking with their healthcare provider to ensure safety and avoid harmful interactions. This conversation is crucial for managing your child's health effectively.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to keep the carton sealed; do not use the product if the carton is opened or if the printed neckband that says "SEALED FOR YOUR PROTECTION" is broken or missing. This helps maintain the safety and effectiveness of the device.

When handling the product, always use the enclosed dosing device as instructed. This ensures that you are using the product safely and effectively. If you have any concerns about the condition of the packaging or the product itself, it's best to consult with a healthcare professional before use.

Additional Information

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

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

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

How often can I give Infants' Ibuprofen?

You can repeat the dose every 6-8 hours, but do not exceed 4 doses in a day.

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 Infants' Ibuprofen safe during pregnancy?

The insert does not provide specific information regarding the use of ibuprofen during pregnancy, so consult a doctor for advice.

What should I do if my child experiences signs of stomach bleeding?

Stop use and call your doctor if your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve.

How should I store Infants' Ibuprofen?

Store Infants' Ibuprofen between 20-25°C (68-77°F) and do not use if the carton is opened or if the seal is broken.

What flavor does Infants' Ibuprofen come in?

Infants' Ibuprofen is available in a mixed berry flavor.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Concentrated Ibuprofen Infants.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NDC 83324-005-30. QUALITY CHOICE Infants' Ibuprofen is a concentrated oral suspension formulated as a nonsteroidal anti-inflammatory drug (NSAID) for pain relief and fever reduction. Each 1.25 mL dose contains 50 mg of ibuprofen and is intended for use in infants aged 6 to 23 months. The product is alcohol-free and dye-free, presented in a mixed berry flavor. The suspension is packaged in a 1 fl oz (30 mL) bottle and is designed for administration using the enclosed syringe. The effects of the medication may last up to 8 hours.

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 recommendations apply:

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

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

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

Doses may be repeated every 6 to 8 hours as needed, but should not exceed 4 doses in a 24-hour period. It is imperative that the maximum dosage is not exceeded to ensure the safety of the child.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer should not use this product, as it may trigger a severe allergic response.

Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with its use in this context.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment increases the risk of stomach bleeding.

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

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Patients should be advised not to use ibuprofen for more than two days or to administer it to children under three years of age without medical guidance.

In cases of overdose, immediate medical attention is required. Healthcare providers should instruct patients or caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Patients should be advised to discontinue use and consult a physician if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain; symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling; lack of relief within the first 24 hours of treatment; worsening fever or pain lasting more than three days; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

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, the use of NSAIDs, excluding aspirin, 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 of the recommended dosage or for prolonged periods.

Patients should be advised to seek medical attention if they experience severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition.

Common adverse reactions may include gastrointestinal discomfort, and patients should be instructed to discontinue use and consult a healthcare provider if symptoms do not improve within 24 hours, if fever or pain worsens or persists beyond three days, or if any new symptoms arise.

Before using this product, it is recommended that patients consult a healthcare provider if they have a history of stomach problems, are dehydrated, or have underlying health 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

Ibuprofen is associated with significant pharmacodynamic interactions, particularly concerning the risk of gastrointestinal bleeding. The concomitant use of ibuprofen with anticoagulants or steroid medications may markedly increase the likelihood of severe stomach bleeding. Healthcare professionals should exercise caution when prescribing ibuprofen to patients who are concurrently taking these classes of drugs.

Additionally, the risk of gastrointestinal bleeding is further heightened if ibuprofen is used alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. It is advisable to monitor patients closely for signs of gastrointestinal distress and consider dosage adjustments or alternative therapies to mitigate this risk.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

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

Packaging configurations for Concentrated Ibuprofen Infants.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this product unless directed by a healthcare professional. For dosing, the following guidelines apply: infants under 6 months should consult a doctor before use; for those 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 recommended dose is 1.875 mL.

Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, is taking other medications, or has experienced significant fluid loss due to vomiting or diarrhea. If any signs of stomach bleeding or symptoms indicative of heart problems or stroke occur, use should be discontinued, and a doctor should be consulted immediately.

To minimize the risk of stomach upset, the product should be administered with food or milk. It is important to adhere to the recommended dosing guidelines, ensuring that no more than 4 doses are given in a single day.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided text. The insert does not mention any contraindications or risks associated with ibuprofen use during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. The insert also does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may also be beneficial in guiding the management of the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding problems, or those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

There is an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, associated with NSAID use. Reports have also indicated severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting. Symptoms indicative of stomach bleeding may include feeling faint, vomiting blood, having bloody or black stools, and experiencing stomach pain that does not improve.

Furthermore, symptoms suggestive of heart problems or stroke have been reported, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, and leg swelling. Additional reports have highlighted a lack of relief within the first 24 hours of treatment, worsening fever or pain lasting more than three days, the presence of redness or swelling in the painful area, and the emergence of any new symptoms.

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 that the medication be taken with food or milk if the patient experiences stomach upset.

Providers should encourage patients to consult a doctor before use if any of the following conditions apply to the child: a warning for stomach bleeding, a history of stomach problems such as heartburn, previous serious side effects from pain relievers or fever reducers, inadequate fluid intake, significant fluid loss due to vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or if the child is taking a diuretic.

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

Patients should be instructed to discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also be alerted to 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.

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

Storage and Handling

The product is supplied in a carton that must remain sealed until use. It is essential to inspect the carton for any signs of tampering; do not use if the carton is opened or if the printed neckband, which states "SEALED FOR YOUR PROTECTION" and "USE WITH ENCLOSED DOSING DEVICE ONLY," is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 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. In the event of an overdose, it is crucial for patients to 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 Concentrated Ibuprofen Infants, 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 Concentrated Ibuprofen Infants, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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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.