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Profen Ib

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Active ingredient
Ibuprofen 100 mg/5 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
June 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 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
June 13, 2025
Manufacturer
Publix Super Markets Inc
Registration number
ANDA074937
NDC root
56062-897
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

profenIB is an oral suspension that contains ibuprofen (a type of medication that helps relieve pain and reduce fever) at a concentration of 100 mg per 5 mL. It is designed for children aged 2 to 11 years and is effective in alleviating minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, profenIB helps to lower fever and provides relief that can last up to 8 hours. This medication is alcohol-free and comes in a pleasant berry flavor, making it easier for children to take.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It’s also effective in reducing fever, making it a helpful option when you're feeling unwell.

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

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use. You should find the right dose by referring to the dosing chart provided, which is based on weight. If weight is not available, you can use age as a guide.

Use the enclosed dosing cup to measure the medication accurately; do not use any other device. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day. After each use, wash the dosing cup to keep it clean, and always replace the original bottle cap to ensure it remains child-resistant. If your child weighs under 24 pounds (or is under 2 years old), consult a doctor for guidance on the appropriate dosage.

What to Avoid

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

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

Side Effects

Ibuprofen can cause serious 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, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, 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, 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, asthma (wheezing), shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding 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 symptoms of heart problems like chest pain or trouble breathing, 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 take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, ibuprofen is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your developing baby, including potential cardiovascular effects.

Before taking ibuprofen, you should consult with your healthcare provider to discuss any concerns and explore safer alternatives for pain relief or inflammation management during pregnancy. Your health and the health of your baby are the top priority, so always seek professional advice when considering medication.

Lactation Use

If you are breastfeeding and considering using this product, it's important to consult your doctor first. There is a possibility that the medication can pass into your breast milk, and the effects of ibuprofen on nursing infants have not been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

If you do take ibuprofen while nursing, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help you weigh the benefits and risks to ensure both you and your infant stay healthy.

Pediatric Use

It's important to be cautious when giving medication to children. This medication should not be used in children under 3 years of age unless a doctor specifically advises it. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, children weighing between 24-35 pounds (ages 2-3 years) can take 5 mL, while those weighing 72-95 pounds (11 years) can take 15 mL. Always consult a doctor for the correct dosage, especially if your child has any health issues or is taking other medications.

Make sure to keep this medication out of reach of children. If your child has a history of stomach problems, high blood pressure, heart disease, liver or kidney issues, or if they are dehydrated, do not give them this medication without consulting a doctor. If you suspect an overdose, seek medical help immediately. You can repeat the dose every 6-8 hours, but do not exceed four doses in a day.

Geriatric Use

It's important to note that the product does not provide specific directions or complete warnings for adult use, including older adults. Additionally, there are no particular recommendations for dosage adjustments or safety concerns for elderly patients mentioned in the information provided.

As you consider this product, it may be wise to consult with a healthcare professional to ensure it meets your needs, especially if you are an older adult or caring for one. Always prioritize safety and proper guidance when it comes to medication 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 doctor can 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 (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 issues like high blood pressure, heart disease, or kidney disease, these conditions can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have to receive the best care possible.

Drug Interactions

It's important to be aware of potential interactions when taking medications. For instance, if you or your child are using ibuprofen, be cautious if there is a known allergy to aspirin, as this 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. The same applies if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Always discuss any medications your child is taking with a healthcare provider. This ensures that you understand the risks and can take steps to avoid serious side effects. Your healthcare provider can help you navigate these interactions safely.

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 use, check the printed neckband; do not use the product if it is broken or missing, as this could compromise its safety and effectiveness.

By following these simple storage and handling guidelines, you can help maintain the quality and reliability of your product.

Additional Information

You should take this medication orally, and if needed, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. To help prevent stomach upset, consider taking it with food or milk. Always use the enclosed dosing cup for accurate measurement, and make sure to wash it after each use.

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

FAQ

What is profenIB?

ProfenIB is an ibuprofen oral suspension that contains 100 mg of ibuprofen per 5 mL, designed for children ages 2 to 11 years.

What does profenIB do?

ProfenIB is a pain reliever and fever reducer that helps relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache.

How should I dose profenIB?

Use the enclosed dosing cup to measure the dose based on your child's weight or age, and do not exceed 4 doses in a day.

What are the side effects of profenIB?

Possible side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke. Consult a doctor if any serious symptoms occur.

Can I give profenIB to my child if they have allergies?

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

Is profenIB safe during pregnancy?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated, especially during the third trimester.

What should I do if my child has a stomach upset?

If your child experiences stomach upset, give profenIB with food or milk to help alleviate the discomfort.

How should I store profenIB?

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

What should I do in case of an overdose?

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

Can I use profenIB for a sore throat?

ProfenIB can be used for a sore throat, but consult a doctor if the sore throat is severe or accompanied by high fever, headache, nausea, or vomiting.

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 formulated to provide pain relief and reduce fever, containing 100 mg of ibuprofen per 5 mL. This nonsteroidal anti-inflammatory drug (NSAID) is designed for oral administration and is presented in a 4 FL OZ (120 mL) bottle. The suspension is alcohol-free and features a berry flavor for palatability. The effects of the medication can last up to 8 hours, making it suitable for managing symptoms in pediatric patients. This product is comparable to the active ingredient found in Children’s Motrin®.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

This product is intended for use in children, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the child's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be used for accurate measurement; no other dosing devices should be employed.

For children weighing under 24 lbs (under 2 years), it is advised to consult a doctor for appropriate dosing. For children weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (4-5 years), the dose increases to 7.5 mL. Children weighing 48-59 lbs (6-8 years) should receive 10 mL, while those weighing 60-71 lbs (9-10 years) should be given 12.5 mL. For children weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

Dosing may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly. To maintain child resistance, the original bottle cap must be replaced securely after each use. It is crucial to adhere strictly to the recommended dosages and not exceed the directed amounts.

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

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

NSAIDs, with the exception of aspirin, are known to increase the risk of serious cardiovascular events, including heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for prolonged periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. It is advised to consult a physician promptly in such cases. Furthermore, ibuprofen should not be administered for more than two days, nor should it be given to children under three years of age unless specifically directed by a healthcare provider.

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

In the event of an overdose, immediate medical attention should be sought, or contact should be made with a Poison Control Center at 1-800-222-1222.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this NSAID-containing 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 carries a warning for potential severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, or naproxen). The risk of stomach bleeding is heightened if the medication is taken in higher doses or for extended periods beyond the recommended duration.

Additionally, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk escalates with prolonged use or higher than directed dosages.

Common adverse reactions may include severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, which may indicate a serious condition requiring prompt medical consultation.

Patients should 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.

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

Before using this product, it is advisable 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. 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, should also seek medical advice prior to use. Furthermore, patients under a physician's care for any serious condition or those taking other medications should consult a doctor or pharmacist before use.

Drug Interactions

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

Pharmacodynamic Interactions:

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

  • Increased Risk of Gastrointestinal Bleeding: The concomitant use of ibuprofen with anticoagulants (blood thinners) or steroid medications significantly elevates the risk of stomach bleeding. Clinicians should monitor patients closely for signs of gastrointestinal distress and consider alternative pain management strategies in these cases.

  • Coadministration with Other NSAIDs: The risk of stomach bleeding is also heightened when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. It is advisable to avoid the concurrent use of multiple NSAIDs to mitigate this risk.

Laboratory Test Interactions:

  • No specific laboratory test interactions have been identified in the available data. Regular monitoring of patient response to therapy is recommended, although no particular tests are indicated.

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 doctor. For children aged 2 to 11 years, dosing is based on weight and age, as outlined in the following chart:

  • Under 24 lbs / Under 2 years: Ask a doctor

  • 24-35 lbs / 2-3 years: 5 mL

  • 36-47 lbs / 4-5 years: 7.5 mL

  • 48-59 lbs / 6-8 years: 10 mL

  • 60-71 lbs / 9-10 years: 12.5 mL

  • 72-95 lbs / 11 years: 15 mL

Dosing may be repeated every 6-8 hours, not exceeding 4 doses in a 24-hour period. It is essential to keep the medication out of reach of children. In the event of an overdose, medical assistance should be sought immediately, or a Poison Control Center should be contacted.

Caution is advised for pediatric patients with a history of stomach problems, such as heartburn, or those who have had an allergic reaction to ibuprofen or other pain relievers/fever reducers. The medication should not be administered if the child is dehydrated, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke. Additionally, it should not be given to children taking diuretics or those under a doctor's care for any serious condition.

Geriatric Use

Elderly patients may not have specific recommendations for the use of this product, as the prescribing information does not include directions or complete warnings for adult use. Additionally, there are no dosage adjustments or safety concerns explicitly noted for geriatric patients.

Healthcare providers should exercise caution when prescribing this product to elderly patients, considering the lack of tailored guidance and the potential for variability in drug response among this population. Monitoring for efficacy and adverse effects is advisable to ensure patient safety.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during this period may pose risks, including potential cardiovascular effects on the developing fetus.

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

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

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 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 the need for alternative therapeutic options. Regular follow-up assessments are advised to monitor for any changes in liver function that may necessitate further dosage modifications or discontinuation of therapy.

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 timely medical help can significantly influence outcomes. 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.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation 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 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 ongoing safety monitoring.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients that this medication should not be used if the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after heart surgery.

Patients should be instructed to stop use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, healthcare providers should emphasize the importance of discontinuing use and seeking medical advice if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

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

When administering this product, healthcare providers should recommend giving it with food or milk to mitigate potential stomach upset. It is important for patients to consult a doctor before use if the stomach bleeding warning is applicable to their child or if the child has a history of stomach issues, such as heartburn. Additionally, patients should be advised to seek medical guidance if the child has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea.

Healthcare providers should also recommend consulting a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as if the child has asthma or is taking a diuretic. Lastly, patients should be encouraged to speak with 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.

Healthcare professionals should also 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 dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to take the medication with food or milk if gastrointestinal upset occurs.

Patient counseling should emphasize the importance of keeping the medication out of reach of children and the necessity of seeking immediate medical assistance or contacting a Poison Control Center (1-800-222-1222) in the event of an overdose. Patients are instructed to use only the enclosed dosing cup for administration and to wash it after each use to ensure accurate dosing.

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

Last AI update:

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.