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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 2024
Label revision date
April 10, 2024
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 2024
Label revision date
April 10, 2024
Manufacturer
Aurohealth LLC
Registration number
ANDA213506
NDC root
58602-227
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Ibuprofen is a concentrated oral suspension designed for infants, specifically formulated as a pain reliever and fever reducer. It contains 50 mg of ibuprofen per 1.25 mL and is suitable for children aged 6 months to 23 months. This medication works by reducing fever and alleviating minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches.

The berry-flavored drops are easy to administer using the enclosed syringe and provide relief that can last up to 8 hours, helping to keep your little one comfortable during times of discomfort.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It is 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 adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before use.

To find the right dose for your child, refer to the dosing chart. If possible, use your child's weight for the most accurate measurement; otherwise, you can use their age. For measuring, use the dosing device that comes with the product—do not use any other device. When giving the liquid, dispense it slowly into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to give more than 4 doses in a single day.

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

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

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

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening. Symptoms to watch for include chest pain, trouble breathing, weakness on one side of the body, slurred speech, or swelling in the legs. If your child experiences any signs of stomach bleeding, such as faintness, vomiting blood, or black stools, or if their sore throat is severe or accompanied by high fever, seek medical attention immediately. Always consult a doctor if your child has any pre-existing health conditions or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

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

If your sore throat is severe or lasts more than two days, or if it is accompanied by high fever, headache, nausea, or vomiting, consult your doctor. For any overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Always stop use and call your doctor if your child does not feel better within 24 hours, if symptoms worsen, or if new symptoms appear.

Overdose

If you suspect an overdose, it's important to be aware that there is no specific information available about the effects or symptoms related to an overdose of this medication. However, if you experience unusual symptoms or feel unwell after taking the medication, you should seek medical attention immediately.

Signs of an overdose can vary, but if you notice any severe or concerning symptoms, do not hesitate to contact a healthcare professional or call emergency services. It's always better to be safe and get checked out if you have any doubts about your health after taking a medication.

Pregnancy Use

The safety of ibuprofen during pregnancy has not been established, and it is generally not recommended, especially in the third trimester (the final three months of pregnancy). Using ibuprofen may pose risks to your developing baby, including potential cardiovascular issues.

If you are pregnant or planning to become pregnant, it is important to consult your healthcare provider before taking ibuprofen or any medication. They can help you understand the risks and suggest safer alternatives for managing pain or inflammation during this time.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of ibuprofen while nursing. The information available does not indicate any concerns about ibuprofen being passed into breast milk or any associated risks for your infant.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

You should avoid giving ibuprofen to children under 6 months old unless a doctor specifically advises it. For children aged 6 to 11 months who weigh between 12 to 17 pounds, the recommended dose is 1.25 mL. If your child is between 12 to 23 months and weighs 18 to 23 pounds, the dose increases to 1.875 mL. It's important to consult a doctor if your child has a severe or persistent sore throat, especially if they also have a high fever, headache, nausea, or vomiting.

For children under 3 years old, do not use ibuprofen for more than 2 days without a doctor's guidance. If your child has a history of stomach ulcers, bleeding issues, heart disease, liver cirrhosis, kidney disease, or asthma, check with a doctor before using ibuprofen. Additionally, if your child is taking other medications, including diuretics, it's wise to consult a doctor or pharmacist first. If you notice any signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop using ibuprofen and seek medical help. Lastly, if your child does not feel better within 24 hours or if their fever or pain worsens or lasts more than 3 days, 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 is important to approach any medication with caution. Since the insert mainly discusses pediatric use, you should consult with a healthcare professional before using this medication if you or a loved one is an older adult.

Always consider that older adults may have different health needs and may be taking other medications that could interact with ibuprofen. It's essential to discuss any potential risks or necessary adjustments in dosage with your doctor to ensure safety and effectiveness.

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 for patients with 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be aware that ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Additionally, if your child is taking blood thinners (medications that help prevent blood clots) or steroids, the risk of severe stomach bleeding increases. This risk is also heightened if your child is using other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

To ensure your child's safety, always consult with a healthcare provider before starting ibuprofen or any other medication. Discussing all medications your child is taking, including over-the-counter drugs, is crucial to avoid potentially dangerous interactions.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). It's important to check the packaging before use; do not use the product if the carton is opened or if the seal under the cap is broken or missing.

When handling the product, make sure to use only the enclosed syringe, as this is designed specifically for safe and effective use. Following these guidelines will help you maintain the integrity of the product and ensure your safety.

Additional Information

You should take this medication orally, and if needed, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. If your child experiences stomach upset, it's best to take the medication with food or milk.

Be alert for any concerning signs: if your child shows symptoms of stomach bleeding, heart problems, or stroke, stop using the medication and consult a doctor. Additionally, if there is no relief within the first 24 hours, if fever or pain worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise, seek medical advice.

FAQ

What is Ibuprofen?

Ibuprofen is a concentrated infants' drops oral suspension (NSAID) that acts as a pain reliever and fever reducer, available in a berry flavor.

What age group can use Ibuprofen?

Ibuprofen is intended for children aged 6 months to 23 months.

How long does Ibuprofen last?

The effects of Ibuprofen can last up to 8 hours.

What should I do before giving Ibuprofen to my child?

You should shake the bottle well before using and measure the dose with the enclosed syringe.

What are the recommended doses for Ibuprofen?

For children 12 to 17 lbs (6 to 11 months), the dose is 1.25 mL; for children 18 to 23 lbs (12 to 23 months), the dose is 1.875 mL.

What are the indications for using Ibuprofen?

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

Are there any contraindications for using Ibuprofen?

Do not use Ibuprofen if your child has had an allergic reaction to it or any other pain reliever/fever reducer, or if they are undergoing heart surgery.

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

Stop using Ibuprofen and consult a doctor if your child feels faint, vomits blood, has bloody or black stools, or has persistent stomach pain.

Can I give Ibuprofen to my child if they have a sore throat?

Consult a doctor if your child has a severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting.

Is it safe to use 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 does not get relief from Ibuprofen?

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

How should Ibuprofen be stored?

Store Ibuprofen between 20° to 25°C (68° to 77°F) and do not use it if the carton is opened or the seal under the cap is broken or missing.

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

AUROHEALTH Ibuprofen is a concentrated oral suspension formulated for infants aged 6 months to 23 months. Each 1.25 mL dose contains 50 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) recognized for its efficacy as a pain reliever and fever reducer. The product is presented in a 1 fl oz (30 mL) bottle and is designed for use with the enclosed syringe to ensure accurate dosing. The formulation features a berry flavor to enhance palatability. The effects of the medication can 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 chart should be referenced for appropriate dosing:

  • 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.

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

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response 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 using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of use increases the risk of gastrointestinal complications.

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. Consultation with a physician is advised if symptoms persist beyond two days or if the patient is under three years of age unless otherwise directed by a healthcare provider.

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

Healthcare professionals should advise caregivers to discontinue use and consult a physician if the child exhibits any of the following signs of potential stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical consultation is necessary. Caregivers should also be alert for the emergence of any new symptoms and seek medical advice accordingly.

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 the potential risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Patients should be advised to adhere strictly to dosing instructions, as prolonged use or exceeding the recommended dosage may increase this risk.

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 duration or dosage.

Patients should be closely monitored for signs of serious conditions, such as severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting, which may necessitate immediate medical consultation.

Patients are advised to discontinue use and seek medical attention if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical evaluation.

If a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should consult a healthcare professional. The presence of redness or swelling in the painful area or the emergence of any new symptoms should also prompt a medical consultation.

Before using this product, patients should consult a healthcare provider if they have a history of stomach problems, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Additional caution is advised for patients with conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as those with asthma or those taking diuretics. It is also recommended that patients under a doctor's care for any serious condition or those taking other medications consult 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 patients with such allergies.

In pediatric patients, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of severe gastrointestinal bleeding. Therefore, it is imperative to monitor these patients closely and consider alternative pain management strategies if they are on these medications.

Additionally, the risk of severe stomach bleeding is elevated when ibuprofen is used alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Healthcare providers should advise parents or guardians to consult a physician before administering ibuprofen if the child is taking any other medications, particularly those that may interact adversely.

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

Ibuprofen should not be administered to pediatric patients under 6 months of age unless specifically directed by a healthcare professional. For children aged 6 to 11 months, weighing between 12 to 17 lbs, the recommended dosage is 1.25 mL. For those aged 12 to 23 months, weighing between 18 to 23 lbs, the recommended dosage increases to 1.875 mL.

Healthcare professionals should advise parents to consult a doctor if the child presents with a severe or persistent sore throat, particularly if accompanied by high fever, headache, nausea, or vomiting. Additionally, ibuprofen should not be used for more than 2 days in children under 3 years of age without medical guidance.

Caution is advised for children with a history of stomach ulcers, bleeding problems, heart disease, liver cirrhosis, kidney disease, or asthma; consultation with a healthcare provider is recommended prior to use in these cases. If the child is taking a diuretic or any other medication, it is important to consult a doctor or pharmacist before administering ibuprofen.

Parents should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, or passing bloody or black stools, and should discontinue use and seek medical attention if these symptoms occur. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, a healthcare professional should be consulted.

Geriatric Use

The prescribing information for Ibuprofen Oral Suspension does not provide specific guidance regarding its use in geriatric patients. There are no recommended age considerations, dosage adjustments, or safety concerns outlined for elderly patients. Consequently, healthcare providers should exercise caution when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful monitoring and individualized assessment of treatment risks and benefits. It is advisable to consider the overall health status and potential comorbidities of elderly patients when determining the appropriateness of Ibuprofen Oral Suspension for their use.

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. It is essential for healthcare professionals to consider these factors when prescribing medications to pregnant patients.

Lactation

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

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 and monitoring.

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 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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution when administering the medication.

Should an overdosage occur, it is essential to monitor the patient closely for any potential symptoms that may arise, although no specific symptoms have been documented in the available literature.

Management of overdosage should be guided by standard medical practices. Healthcare providers are encouraged to implement supportive care measures and to consider symptomatic treatment as necessary. In cases of suspected overdosage, it is recommended to contact a poison control center or seek expert consultation for further guidance on management strategies.

Documentation of the incident and any interventions taken is crucial for ongoing patient care and for reporting purposes.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, instances of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding problems, as well as 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 the use of NSAIDs. Reports have also highlighted severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, as serious conditions that require prompt medical consultation. Furthermore, cases of overdose have been documented, which necessitate immediate medical assistance or contact with a Poison Control Center.

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.

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 stomach pain that does not improve. Additionally, healthcare providers should inform patients to stop use and seek medical advice 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 also be counseled 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 beyond three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

It is important for healthcare providers to remind patients to consult a doctor before use if the warning regarding stomach bleeding applies to their child, or if the child has a history of stomach issues, such as heartburn. Patients should also be advised to seek medical advice if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost significant fluid due to vomiting or diarrhea.

Furthermore, healthcare providers should recommend that patients consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking a diuretic should also be advised to seek medical consultation prior to use. Lastly, it is prudent for patients to discuss with a doctor or pharmacist if the child is under care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes an enclosed syringe. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy.

Healthcare professionals should ensure that the carton remains unopened and that the seal under the cap is intact and unbroken prior to use. If the carton is opened or the seal is broken or missing, the product should not be used.

Additional Clinical Information

The route of administration for the medication is oral, with a recommended repeat dose every 6 to 8 hours as needed, not to exceed four doses in a 24-hour period.

Clinicians should counsel patients to take the medication with food or milk if gastrointestinal upset occurs. Patients should be advised to discontinue use and consult a physician if the child exhibits any signs of stomach bleeding, symptoms indicative of heart problems or stroke, fails to achieve relief within the first 24 hours, experiences worsening fever or pain lasting more than three days, shows redness or swelling in the affected area, or develops any new symptoms.

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

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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.