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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/ 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 2015
Label revision date
May 1, 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 2015
Label revision date
May 1, 2025
Manufacturer
Publix Super Markets Inc
Registration number
ANDA075217
NDC root
56062-404
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 nonsteroidal anti-inflammatory drug (NSAID) that helps reduce fever and relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headaches, and toothaches. The effects of profen IB drops can last up to 8 hours, making it a convenient option for managing discomfort in young children.

These drops are dye-free, non-staining, and come in a pleasant berry flavor without high fructose corn syrup, ensuring a more enjoyable experience for your little one. 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’s effective for discomfort caused by common conditions like the cold, flu, sore throat, headaches, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adult use. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use.

To find the right dose for your child, refer to the dosing chart based on their weight. If possible, use your child's weight for dosing; if not, you can use their age. For example, if your child weighs between 12-17 pounds and is 6-11 months old, the dose is 1.25 mL. If they weigh between 18-23 pounds and are 12-23 months old, the dose is 1.875 mL. Always measure the dose using the dosing device provided, as other devices may not be accurate. 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 6-8 hours, but do not give more than four doses in a single day.

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 it right before or after heart surgery, as this could pose serious health risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

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 (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 symptoms such as faintness, vomiting blood, or has bloody or black stools, you should seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always discuss any pre-existing health conditions or medications with a healthcare provider before using ibuprofen.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using 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, stop use and contact your doctor right away.

If you or your child has a severe sore throat that lasts more than two days or is accompanied by high fever, headache, nausea, or vomiting, consult a doctor. For any overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Always monitor for worsening symptoms or new issues, and if relief is not felt within 24 hours, reach out to your healthcare provider.

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

While the information provided does not specify any particular guidelines or risks associated with using ibuprofen during pregnancy, it is important to approach any medication with caution. Currently, there are no stated contraindications or dosage modifications for pregnant individuals regarding ibuprofen. However, since the insert does not mention any special precautions, it is advisable to consult with your healthcare provider before taking ibuprofen or any medication during pregnancy to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any concerns or questions you may have.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that the ingredients may pass into your breast milk, which could pose risks to your infant. Therefore, exercising caution is essential when considering this medication while nursing. Always prioritize your health and your baby's safety by discussing any concerns with your healthcare provider.

Pediatric Use

When using this medication for children aged 6 to 23 months, it's important to follow specific dosage guidelines based on their weight. For infants under 6 months, you should consult a doctor before use. For those between 12 to 17 pounds (6-11 months), the recommended dose is 1.25 mL, and for children weighing 18 to 23 pounds (12-23 months), the dose is 1.875 mL. Additionally, do not use this medication in children under 3 years for more than 2 days unless directed by a doctor.

Before giving this medication, consult your doctor if your child has a history of stomach issues, has experienced serious side effects from pain relievers, is dehydrated, or has any serious health conditions like high blood pressure or asthma. You should also stop use and seek medical advice if your child shows signs of stomach bleeding, heart problems, or if their symptoms do not improve within 24 hours. If fever or pain worsens or lasts more than 3 days, or if any new symptoms arise, contact a healthcare professional immediately.

Geriatric Use

You can feel reassured that there are no specific concerns regarding the use of Profen IB (ibuprofen suspension/drops) for older adults. The information available does not indicate any need for dosage adjustments or special safety precautions for elderly patients. This means that, as a caregiver or an older adult, you can use this medication without worrying about unique risks associated with age. Always remember to follow the recommended dosage instructions and consult with a healthcare professional if you have any questions or concerns about its use.

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 healthcare provider can help determine if this medication is safe for you and whether any adjustments are needed based on your kidney function. Always prioritize your health and seek professional advice to ensure your safety.

Hepatic Impairment

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

Additionally, if you have other health conditions like high blood pressure, heart disease, or kidney disease, these factors can also influence your care plan. Always communicate openly with your healthcare team about your liver health and any other medical issues you may have, so they can provide the best possible guidance tailored to your needs.

Drug Interactions

It's important to be aware of potential interactions when taking ibuprofen. If you or your child are allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen are being used.

Using ibuprofen can also raise the chances of serious heart issues, such as heart attack or stroke, especially if taken in higher doses or for longer than recommended. Always consult your healthcare provider before starting ibuprofen or if your child is taking any other medications, to ensure safety and avoid harmful interactions.

Storage and Handling

To ensure the best performance 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 use, check the printed neckband; do not use the product if it is broken or missing, as this could compromise safety.

By following these simple storage and handling guidelines, you can help maintain the integrity and effectiveness of your device.

Additional Information

You should take this medication orally, every 6 to 8 hours as needed, but do not exceed 4 doses in a day. It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. If you experience stomach upset, consider taking the medication with food or milk to help alleviate discomfort.

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 is used to 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 is intended for infants 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 schedule for Profen IB drops?

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

Are there any warnings associated with Profen IB drops?

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

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

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

Can I use Profen IB drops if my child has allergies?

Do not use Profen IB drops if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

Is it safe to use Profen IB drops during pregnancy?

The insert does not provide specific information regarding the use of ibuprofen during pregnancy.

What should nursing mothers know about using Profen IB drops?

Nursing mothers should consult a doctor before using this product due to the potential for ibuprofen to be excreted in breast milk.

How should I store Profen IB drops?

Store Profen IB drops at 68-77°F (20-25°C) and do not freeze. Do not use if the printed neckband is broken or missing.

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

Ibuprofen oral suspension is a concentrated formulation providing 50 mg of ibuprofen per 1.25 mL. This non-steroidal anti-inflammatory drug (NSAID) serves as a pain reliever and fever reducer, with effects lasting up to 8 hours. The product is dye-free, non-staining, and flavored with berry, while containing no high fructose corn syrup. It is packaged in a 1 FL OZ (30 mL) bottle and is intended for use exclusively with the enclosed syringe.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the child's weight and age. It is essential to shake the product well before each use. The dosing device provided should be used for measurement; no other devices should be utilized to ensure accurate dosing.

For administration, dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek. If necessary, doses may be repeated every 6 to 8 hours, but it is crucial not to exceed 4 doses in a 24-hour period.

Dosing Chart:

  • For infants under 6 months of age or weighing less than 12 lbs, consultation with a physician is recommended.

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

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

Healthcare professionals should ensure that caregivers are aware of the importance of adhering to these guidelines and not exceeding the recommended dosages.

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 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.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, it is crucial to consult a physician promptly. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

In the event of an overdose, immediate medical attention is required. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: signs of stomach bleeding such as faintness, vomiting blood, 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; lack of relief within the first 24 hours of treatment; worsening fever or pain lasting more than three days; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

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 potential severe stomach bleeding. The risk of this adverse reaction 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 longer durations than recommended.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, particularly when the medication is used beyond the directed dosage or duration.

In clinical settings, patients presenting with severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, should seek medical attention promptly. It is advised not to use ibuprofen for more than two days in such cases or to administer it to children under three years of age without a doctor's guidance.

Patients are advised to discontinue use and consult a healthcare professional 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 consultation. Furthermore, 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, medical advice should be sought. The presence of redness or swelling in the painful area or the emergence of any new symptoms should also prompt a consultation.

Before using ibuprofen, it is essential for patients to consult a healthcare provider 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 with dehydration, 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 to seek advice from a doctor or pharmacist if the patient is under medical care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration.

Allergic Reactions Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. It is crucial for healthcare providers to assess the patient's allergy history before prescribing ibuprofen.

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. This risk is further elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as aspirin and naproxen. Monitoring for signs of gastrointestinal distress is advised in patients receiving these combinations.

Cardiovascular Risks The use of ibuprofen has been linked to an increased risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when ibuprofen is used in higher doses or for extended periods. Healthcare providers should evaluate the necessity of ibuprofen therapy and consider alternative treatments when appropriate.

Consultation Recommendations It is recommended that healthcare providers consult with a physician if the patient is taking any other medications. This ensures a comprehensive review of potential interactions and the implementation of necessary dosage adjustments or monitoring strategies.

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 aged 6 to 23 months require specific dosing based on weight. For infants under 6 months, consultation with a doctor is advised. For those weighing 12-17 lbs (6-11 months), the recommended dose is 1.25 mL, while those weighing 18-23 lbs (12-23 months) should receive 1.875 mL.

It is important to note that this medication should not be used in children under 3 years of age for more than 2 days unless directed by a healthcare professional. Prior to administration, healthcare providers should be consulted if the child has a history of stomach issues, adverse reactions to pain relievers or fever reducers, inadequate fluid intake, significant fluid loss from vomiting or diarrhea, or pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are taking a diuretic or any other medication.

Parents and caregivers should be advised to discontinue use and seek medical attention if the child exhibits signs of stomach bleeding (e.g., faintness, vomiting blood, bloody or black stools, persistent stomach pain), symptoms indicative of heart problems or stroke (e.g., chest pain, difficulty breathing, unilateral weakness, slurred speech, leg swelling), does not achieve relief within the first 24 hours of treatment, experiences worsening fever or pain lasting more than 3 days, shows redness or swelling in the affected area, or develops any new symptoms.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns noted in the prescribing information for Profen IB (ibuprofen suspension/drops). Therefore, standard dosing guidelines may be applied to this population without the need for modification. However, healthcare providers should remain vigilant in monitoring for any potential adverse effects, as individual responses to medication can vary among geriatric patients.

Pregnancy

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

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, or liver cirrhosis, as these may influence the management of their renal function 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 the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment course to ensure safety and efficacy.

Additionally, patients with a history of significant cardiovascular conditions, such as high blood pressure or heart disease, as well as those with kidney disease or a history of stroke, should be evaluated carefully, as these factors may further complicate the management of their hepatic condition.

Overall, a thorough assessment of each patient's individual health status is crucial in determining the appropriate therapeutic approach for those with hepatic impairment.

Overdosage

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

Prompt intervention is crucial in managing overdose situations, as symptoms may vary depending on the substance involved. It is essential for healthcare providers to assess the patient's condition thoroughly and initiate appropriate management procedures based on the specific circumstances of the overdose.

Monitoring and supportive care may be necessary, and healthcare professionals should be prepared to implement standard protocols for overdose management, which may include symptomatic treatment and stabilization of the patient.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include hives, facial swelling, asthma characterized by wheezing, shock, skin reddening, rash, and blisters.

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 history of stomach problems, such as heartburn, or if there is a concern regarding stomach bleeding. Additionally, it is important to ask a doctor before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea.

Patients should also be advised to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke. Furthermore, it is essential to ask a doctor before use if the child has asthma or is taking a diuretic.

Lastly, healthcare providers should recommend that patients consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

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

Freezing the product is strictly prohibited, as it may compromise its quality. Additionally, healthcare professionals should ensure that the product is not used if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial for optimal product performance.

Additional Clinical Information

The medication is administered orally, with a recommended frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. If patients experience stomach upset, it is recommended to take the medication with food or milk.

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.