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Profen Ib

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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 2001
Label revision date
July 17, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2001
Label revision date
July 17, 2025
Manufacturer
Publix Super Markets Inc
Registration number
ANDA075217
NDC root
56062-057
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

Profen IB drops are a concentrated oral suspension containing ibuprofen, designed specifically for infants aged 6 to 23 months. Each 1.25 mL dose provides 50 mg of ibuprofen, which is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). This medication is commonly used to relieve pain and reduce fever, providing relief that can last up to 8 hours.

These drops come in a pleasant berry flavor and do not contain high fructose corn syrup, making them a suitable option for young children. It's important to use the enclosed syringe for accurate dosing.

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.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause developmental issues in a fetus.

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 use. You can find the right dose by referring to the dosing chart, which is based on your child's weight. If possible, use their weight for dosing; if not, you can use their age instead.

When measuring the dose, use the dosing device that comes with the product, as other devices may not provide accurate measurements. For administration, slowly dispense the liquid into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day. For infants under 6 months, it's best to consult a doctor before giving this medication. For children weighing between 12 to 17 pounds (6 to 11 months old), the dose is 1.25 mL, and for those weighing 18 to 23 pounds (12 to 23 months old), the dose is 1.875 mL.

What to Avoid

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 guidelines 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, please consult with your doctor.

Side Effects

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

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences severe or persistent sore throat, high fever, or symptoms of stomach bleeding (such as faintness, vomiting blood, or black stools), or shows signs of heart problems or stroke (like chest pain or weakness on one side of the body), seek medical attention immediately. Always consult a doctor before use 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 problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

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

Overdose

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

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

Pregnancy Use

The safety of ibuprofen during pregnancy has not been established, and it is particularly contraindicated (not recommended) during the third trimester. Using ibuprofen while pregnant may pose risks to your fetus, including potential cardiovascular effects.

If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider before using ibuprofen. They can help you understand the risks and explore safer alternatives for managing pain or inflammation during this important 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 using this medication in children under 3 years old unless a doctor specifically advises you to do so. For children aged 6 to 23 months, the dosage depends on their weight: if your child weighs between 12-17 pounds, the dose is 1.25 mL, and for those weighing 18-23 pounds, the dose is 1.875 mL.

If your child has not been drinking fluids or has lost a lot of fluids due to vomiting or diarrhea, it's important to consult a doctor. Additionally, if you notice any signs of stomach bleeding—such as faintness, vomiting blood, or black stools—stop using the medication and seek medical advice. Be alert for symptoms of heart problems or stroke, like chest pain or trouble breathing, and consult a doctor if your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days.

Geriatric Use

If you are caring for an older adult, it's important to be aware that they may be more sensitive to the side effects of certain medications. This means that extra caution is needed when giving this product to elderly patients. Always consult a doctor if the individual has any existing health issues, such as high blood pressure, heart disease, liver cirrhosis (severe liver damage), kidney disease, or a history of stroke.

Additionally, if the older adult has experienced serious side effects from pain relievers or fever reducers in the past, special precautions should be taken. It's also worth noting that if they have a history of stomach problems, like heartburn, there may be an increased risk of stomach bleeding. Always prioritize safety and seek medical advice when necessary.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your doctor will help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your health and safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any medications you are considering.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (blood tests that check how well your liver is working) to ensure your safety and the effectiveness of the treatment.

Additionally, if you have other health conditions like high blood pressure, heart disease, or kidney disease, these may also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical issues you may have.

Drug Interactions

It's important to be aware that ibuprofen can interact with certain medications. For instance, if you are taking blood thinners (medications that help prevent blood clots) or steroid drugs, ibuprofen may affect how these medications work. Additionally, using ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen, can also lead to interactions.

To ensure your safety and the effectiveness of your treatment, always discuss any medications you are taking with your healthcare provider. This includes both prescription and over-the-counter drugs. They can help you understand potential interactions and make informed decisions about your health.

Storage and Handling

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

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

Additional Information

You should take this medication orally, dispensing the liquid slowly into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day.

It's important to keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is profen IB drops?

Profen IB drops is a concentrated ibuprofen oral suspension that contains 50 mg of ibuprofen per 1.25 mL.

What are the uses of profen IB drops?

Profen IB drops reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

Who can use profen IB drops?

Profen IB drops are intended for children aged 6 to 23 months.

How should I administer profen IB drops?

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

What is the dosing for profen IB drops?

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

What should I do if my child experiences side effects?

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

Are there any contraindications for using profen IB drops?

Do not use profen IB drops if your child has had an allergic reaction to ibuprofen or any other pain reliever, or if they are undergoing heart surgery.

Can I use profen IB drops 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 in case of an overdose?

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

How should I store profen IB drops?

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

Packaging Info

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

Packaging configurations for Profen Ib.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Profen IB drops are a concentrated oral suspension of ibuprofen, delivering 50 mg of ibuprofen per 1.25 mL. This formulation serves as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). The product is free from high fructose corn syrup and is presented in a berry flavor. Each bottle contains 0.5 fluid ounces (15 mL) of the suspension.

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 secondary reference.

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 provides guidance based on weight and age:

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

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

  • For children weighing between 18-23 lbs (approximately 12-23 months of age), 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 safety.

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

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. Ibuprofen should not be used for more than two days or administered to children under three years of age unless specifically directed by a healthcare provider.

Healthcare providers should advise caregivers to discontinue use and seek medical attention if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, including 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. Any new symptoms that arise should also prompt a discussion with a healthcare professional.

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

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in severity.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen, as 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. Additionally, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended duration.

There is also a significant warning regarding the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified when the medication is used in excess of the directed dosage or for longer than advised.

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

Patients are instructed to discontinue use and seek medical advice if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if there is no relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical consultation is recommended. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a discussion with a healthcare provider.

Before using ibuprofen, it is essential for patients to consult a doctor if they have a history of stomach issues, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Additional caution is advised for patients who have not been adequately hydrated, have lost significant fluids due to vomiting or diarrhea, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking diuretics should also seek medical advice prior to use.

Lastly, it is recommended that patients under a doctor's care for any serious condition or those taking other medications consult with a healthcare professional before using ibuprofen.

Drug Interactions

Ibuprofen has several notable interactions with other drug classes that may affect its clinical use.

Anticoagulants: Ibuprofen may enhance the effects of blood-thinning medications, potentially increasing the risk of bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments of anticoagulants as necessary.

Corticosteroids: The concomitant use of ibuprofen with steroid drugs may increase the risk of gastrointestinal adverse effects, such as ulceration or bleeding. Clinicians should evaluate the necessity of both medications and monitor for gastrointestinal complications.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Ibuprofen may interact with other NSAIDs, including prescription and nonprescription medications such as aspirin and naproxen. The combined use of these agents can elevate the risk of adverse effects, particularly gastrointestinal toxicity. It is recommended to avoid the concurrent use of multiple NSAIDs unless specifically directed by a healthcare professional.

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

Packaging & NDC

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

Packaging configurations for Profen Ib.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. The recommended dosing for pediatric patients aged 6 to 23 months is based on weight: for those weighing 12-17 lbs (approximately 6-11 months), the dose is 1.25 mL; for those weighing 18-23 lbs (approximately 12-23 months), the dose is 1.875 mL.

Healthcare professionals should advise caregivers to consult a doctor if the child has not been drinking fluids or has experienced significant fluid loss due to vomiting or diarrhea. Additionally, if any signs of stomach bleeding occur—such as faintness, vomiting blood, bloody or black stools, or persistent stomach pain—the medication should be discontinued, and medical advice sought.

Caregivers should also be alert for symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, and should stop use and consult a doctor if these symptoms arise. 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

Elderly patients may exhibit increased sensitivity to side effects associated with this product. Therefore, caution is advised when administering it to this population. It is important for healthcare providers to closely monitor geriatric patients for any adverse reactions, particularly those related to the gastrointestinal system, as the product does not contain specific directions or complete warnings for adult use.

Additionally, healthcare providers should consult with a physician if elderly patients have a history of high blood pressure, heart disease, liver cirrhosis, kidney disease, or prior strokes. Special precautions are warranted for those with a history of gastrointestinal issues, such as heartburn, as the warning regarding stomach bleeding is applicable. Furthermore, if geriatric patients have experienced serious side effects from pain relievers or fever reducers in the past, careful consideration and monitoring are essential when administering this product.

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 pregnancy may pose risks, including potential cardiovascular effects on the developing fetus.

Women of childbearing potential should consult a healthcare provider before using ibuprofen if they are pregnant or planning to become pregnant to discuss the potential risks and benefits.

Lactation

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

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for potential contraindications or restrictions related to the use of this medication. It is crucial to consider the overall health status of these patients, including any coexisting conditions such as high blood pressure, heart disease, or kidney disease, which may further complicate treatment decisions.

Overdosage

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

Prompt intervention is crucial in managing overdose situations effectively. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement emergency protocols as necessary to ensure patient safety and optimal outcomes.

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 the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended to administer the medication with food or milk if the patient experiences stomach upset.

Providers should encourage patients to consult a doctor before use if the child has a warning for stomach bleeding. Additionally, it is important to ask about any history of stomach problems, such as heartburn, as well as any previous serious side effects from pain relievers or fever reducers.

Patients should be instructed to inform their healthcare provider if the child has not been adequately hydrated or has lost significant fluids due to vomiting or diarrhea. It is also crucial to discuss any existing health conditions, including high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as these may affect the safety of the medication.

Furthermore, healthcare providers should inquire whether the child has asthma or is currently taking a diuretic. Patients should also be advised to consult 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 specific NDC numbers. It should be stored at a temperature range of 68-77°F (20-25°C) to maintain its integrity and efficacy. It is imperative that the product is not frozen, as this may compromise its quality. Additionally, the product must not be used if the printed neckband is broken or missing, as this indicates potential tampering or compromise of the product's safety. Proper handling and storage conditions are essential to ensure the product remains safe for use.

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 administered more than four times a day.

Clinicians should counsel patients to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Profen Ib, 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 Profen Ib, 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.