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Ibuprofen Infants Drops

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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 2025
Label revision date
February 4, 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
February 4, 2025
Manufacturer
Harris Teeter, LLC
Registration number
ANDA210755
NDC root
69256-687
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

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

Drug Overview

Ibuprofen is a medication available in concentrated drops specifically designed for infants aged 6 months to 23 months. It is a nonsteroidal anti-inflammatory drug (NSAID) that works as a pain reliever and fever reducer. You can use it to help alleviate minor aches and pains associated with common conditions like the cold, flu, sore throat, headaches, and toothaches.

This formulation is dye-free and comes in a pleasant berry flavor, making it easier for young children to take. Each 1.25 mL dose contains 50 mg of ibuprofen, and its effects can last for up to 8 hours, providing relief when your little one needs it most.

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 experiencing mild pain, 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 give more than directed. To prepare the medication, shake the bottle well before use.

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

For children under 6 months, it's best to consult a doctor before administering this medication. For children aged 6 to 23 months, the doses are as follows: for those weighing 12 to 17 pounds (6 to 11 months), give 1.25 mL; and for those weighing 18 to 23 pounds (12 to 23 months), give 1.875 mL.

What to Avoid

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

Be mindful that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Always follow the guidance provided by your healthcare professional to prevent any issues related to dependence (a condition where the body becomes reliant on a substance). If you have any concerns or questions, don’t hesitate to reach out to your doctor for more information.

Side Effects

Ibuprofen can cause serious allergic reactions, especially in those who are allergic to aspirin. Symptoms to watch for include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. Additionally, this medication may 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.

If your child experiences signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, seek medical attention immediately. Other concerning symptoms include chest pain, difficulty breathing, weakness on one side of the body, or slurred speech. It's important to consult a doctor if your child does not find relief within 24 hours, if symptoms worsen, or if new symptoms arise. Always talk to a healthcare professional before using ibuprofen if your child has any underlying health issues 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 the medication and seek medical help immediately.

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

If you or your child has a severe sore throat with high fever, headache, nausea, or vomiting, consult a doctor promptly. Do not use ibuprofen for more than two days without medical advice, especially for children under three years old. If symptoms do not improve within 24 hours, worsen, or if new symptoms appear, stop use and call your doctor. In case of overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

Taking too much ibuprofen can lead to serious health issues. If you or someone you know has taken an overdose, it's important to be aware of the symptoms, which may include nausea (feeling sick), vomiting, stomach pain, drowsiness (extreme tiredness), and headache.

If you suspect an overdose, seek immediate medical help or contact a Poison Control Center right away. Acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

While the information provided does not specify any particular guidelines or risks associated with using ibuprofen during pregnancy, it is important to approach the use of any medication with caution. Currently, there are no stated contraindications (conditions that would make the use of a drug inadvisable) or dosage modifications for pregnant individuals. However, since the insert does not mention any special precautions, it is advisable to consult with your healthcare provider before taking ibuprofen or any other medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

It's important to be cautious when giving medication to children. You should not use this medication in children under 3 years of age 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 consult a doctor if your child has a history of stomach issues, is taking other medications, or has serious health conditions. Remember not to exceed 4 doses in a day. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, seek medical advice. Additionally, if you notice any signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the medication and contact a doctor immediately.

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, it’s important to consult with a healthcare provider for personalized advice. 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 and what steps to take for your safety.

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 determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want 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 certain medications can interact with each other, potentially leading to serious side effects. For instance, if you or your child are taking ibuprofen, combining it with blood thinners (medications that help prevent blood clots) or steroids can increase the risk of stomach bleeding. Additionally, using ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen, can further elevate this risk.

Always discuss any medications you or your child are taking with your healthcare provider. They can help you understand potential interactions and ensure that your treatment plan is safe and effective.

Storage and Handling

To ensure the safety and effectiveness 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 integrity of the product and ensures that you are using it as intended.

When handling the product, always use the enclosed dosing device to ensure accurate dosing and safety. Following these guidelines will help you use the product effectively and safely.

Additional Information

You should take this medication orally. When giving it to a child, dispense the liquid slowly into their mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a single day.

FAQ

What is Ibuprofen used for?

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?

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

How should I administer Ibuprofen to my child?

Use the enclosed dosing syringe to measure the dose accurately and dispense the liquid slowly into the child's mouth, toward the inner cheek.

What precautions should I take before 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 about to undergo heart surgery.

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

If your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve, stop use and consult a doctor immediately.

Can I give Ibuprofen to my child if they are taking other medications?

Consult a doctor before use if your child is taking other medications, especially blood thinners or other NSAIDs, as this may increase the risk of stomach bleeding.

Is there any information about using Ibuprofen during pregnancy or while nursing?

The provided information does not include specific statements regarding the use of Ibuprofen during pregnancy or lactation.

What should I do if my child's symptoms do not improve?

If your child does not get 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 I store Ibuprofen?

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

Packaging Info

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

Packaging configurations for Ibuprofen Infants Drops.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen is an oral suspension formulated as a concentrated drop for infants, specifically designed for ages 6 months to 23 months. Each 1.25 mL dose contains 50 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) that serves as a pain reliever and fever reducer. The product is dye-free, non-staining, and features a berry flavor to enhance palatability. It is packaged in a 1 FL OZ (30 mL) bottle and is intended for use with the enclosed syringe. The effects of the medication can last up to 8 hours. The product is identified by NDC 69256-687-09 and is comparable to the active ingredient in Motrin® Infants' Drops Dye-Free.

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 dosing devices 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 pounds (approximately 6 to 11 months), the recommended dose is 1.25 mL.

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

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

Contraindications

Use is contraindicated in patients 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 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 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 NSAIDs, excluding aspirin, elevate the 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.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. 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 physician.

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

Healthcare providers should instruct caregivers to discontinue use and consult a physician if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, if symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—medical attention should be sought without delay.

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

Side Effects

Patients 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. The likelihood of these serious cardiovascular events is greater when the medication is used in excess of the recommended dosage or for prolonged periods.

Patients should also be aware of the potential for severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition requiring prompt medical attention.

In clinical trials and postmarketing experiences, it is advised that patients discontinue use and consult a healthcare provider if they do not achieve relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using this product, patients should seek medical advice 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 warranted 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 with a healthcare provider or pharmacist prior to use.

Drug Interactions

Ibuprofen has been associated with an increased risk of gastrointestinal bleeding when co-administered with anticoagulants or corticosteroids. This interaction necessitates careful monitoring of patients who are prescribed these medications concurrently.

Additionally, the risk of gastrointestinal bleeding is further elevated in pediatric patients who are taking ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and naproxen. It is advisable to avoid the concomitant use of multiple NSAIDs in children 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 Ibuprofen Infants Drops (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen Infants Drops.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication 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 children weighing 18-23 lbs (12-23 months), the dose is 1.875 mL.

It is essential to consult a doctor if the child has a history of stomach problems, is taking other medications, or has any serious health conditions. The maximum recommended dosage is 4 doses per day. 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.

Parents and caregivers should be vigilant for signs of stomach bleeding or symptoms indicative of heart problems or stroke; if these occur, use should be discontinued immediately, and a doctor should be consulted.

Geriatric Use

There is no specific information available 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 this period. Additionally, no dosage modifications for pregnant individuals are provided. Furthermore, the insert 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

There are no specific statements regarding the use of this medication in nursing mothers or lactation. Therefore, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants and the excretion of the drug in breast milk have not been established.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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

Overdosage of ibuprofen can lead to significant health risks and requires prompt medical intervention.

Symptoms of Overdose Healthcare professionals should be aware that symptoms of ibuprofen overdose may manifest as nausea, vomiting, stomach pain, drowsiness, and headache. These symptoms can vary in severity depending on the amount ingested and the individual’s health status.

Recommended Actions In the event of an overdose, it is crucial to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a Poison Control Center for further guidance. Timely intervention is essential to mitigate potential complications associated with ibuprofen overdosage.

Nonclinical Toxicology

No teratogenic effects have been reported in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning animal pharmacology and 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, there have been reports of severe stomach bleeding, particularly in children with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroids, or those using other nonsteroidal anti-inflammatory drugs (NSAIDs).

Furthermore, an increased risk of heart attack, heart failure, and stroke has been associated with NSAID use. Symptoms indicative of heart problems or stroke reported include chest pain, difficulty breathing, weakness in one part or side of the body, slurred speech, and leg swelling.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset. This guidance can help mitigate gastrointestinal discomfort and enhance the overall tolerability of the treatment.

Storage and Handling

The product is supplied in a carton that must remain unopened until use. It is essential to verify that the printed neckband is intact, specifically ensuring that the "SEALED FOR YOUR PROTECTION" statement is unbroken and that the "USE WITH ENCLOSED DOSING DEVICE ONLY" instruction is clearly visible.

Storage conditions require that the product be maintained at a temperature range of 20-25°C (68-77°F) to ensure its efficacy and safety. Proper handling is crucial; therefore, any carton that has been opened or shows signs of tampering should not be used.

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 it should not be used more than four times a day.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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