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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 2003
Label revision date
May 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 2003
Label revision date
May 13, 2025
Manufacturer
Publix Super Markets Inc
Registration number
ANDA074937
NDC root
56062-166
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

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

Drug Overview

Ibuprofen Oral Suspension is a medication that provides relief from minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, and toothache. It also helps to reduce fever. This nonsteroidal anti-inflammatory drug (NSAID) is designed for children aged 2 to 11 years and comes in a pleasant bubblegum flavor, making it easier for kids to take.

Each 5 mL dose contains 100 mg of ibuprofen, and its effects can last up to 8 hours. This formulation is alcohol-free, ensuring it is safe for young users. If you're looking for a way to help manage your child's discomfort or fever, ibuprofen oral suspension may be a suitable option.

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. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before using this product, make sure to shake the bottle well. To find the right dose for you or your child, refer to the dosing chart based on weight or age. It's important to use the enclosed dosing cup for accurate measurement—do not use any other device. If you need to take another dose, you can do so every 6 to 8 hours, but remember not to exceed 4 doses in a single day.

For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor for the appropriate dose. For children aged 2 to 3 years and weighing between 24 to 35 pounds, the dose is 5 mL. As the weight increases, so does the dose: 7.5 mL for 4 to 5-year-olds (36-47 lbs), 10 mL for 6 to 8-year-olds (48-59 lbs), 12.5 mL for 9 to 10-year-olds (60-71 lbs), and 15 mL for 11-year-olds (72-95 lbs). After each use, wash the dosing cup and always replace the original bottle cap to keep it child-resistant.

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.

Always prioritize safety by following these guidelines closely. If you have any concerns or questions about your child's health or medication, consult with a healthcare professional for personalized advice.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of a severe allergy 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 fainting, 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 check with a healthcare professional before giving ibuprofen if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

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

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding issues, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, 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 are under three years old. If symptoms do not improve within 24 hours, or if fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get emergency 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

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. These risks can include potential heart problems and kidney issues for the fetus.

Before taking ibuprofen or any medication, you should always consult your healthcare provider. They can help you understand the safest options for managing pain or discomfort during your pregnancy.

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. For children under 3 years of age, you should only use this medication if directed by a doctor. Dosage varies based on your child's weight and age. For example, if your child weighs under 24 pounds and is under 2 years old, consult a doctor first. For children aged 2-3 years weighing 24-35 pounds, the recommended dose is 5 mL, while those aged 4-5 years and weighing 36-47 pounds should receive 7.5 mL. As your child grows, the dosage increases, so be sure to follow the guidelines carefully.

Always keep the medication out of reach of children. If you suspect an overdose, seek medical help immediately. Before giving this medication, check with a doctor if your child has had any allergic reactions to pain relievers or fever reducers. Be aware of potential side effects, such as stomach bleeding, especially if your child has a history of ulcers or is taking other medications. If your child experiences any serious side effects, does not find relief within 24 hours, or if their symptoms worsen, contact a doctor right away. To help prevent stomach upset, consider giving the medication with food or milk.

Geriatric Use

When considering this product, it's important to note that it does not provide specific directions or complete warnings for adult use, including older adults. This means that if you or a loved one is an older adult, you should be particularly cautious and consult with a healthcare professional before using it.

Always ensure that any medication or treatment is appropriate for your individual health needs, especially if there are existing health conditions or concerns. Your healthcare provider can help guide you on safe usage and any necessary adjustments based on age-related factors.

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 open communication with your doctor regarding your health conditions.

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 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, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious side effects. For instance, if you or your child are taking ibuprofen, combining it with blood thinners (medications that help prevent blood clots) or steroids can increase the risk of stomach bleeding. This risk is even greater if other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, are also being used.

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

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 and affect its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single 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 Ibuprofen Oral Suspension used for?

Ibuprofen Oral Suspension is used to relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

What is the recommended dosage for children?

The dosage varies by weight and age. For example, children aged 2-3 years weighing 24-35 lbs should take 5 mL, while those aged 11 years weighing 72-95 lbs should take 15 mL.

How often can I give Ibuprofen Oral Suspension?

You can repeat the dose every 6-8 hours, but do not use more than 4 times a day.

Are there any warnings associated with Ibuprofen?

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.

Can I use Ibuprofen Oral Suspension if my child is pregnant or breastfeeding?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated in the third trimester. Nursing mothers should consult a doctor before use.

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 immediately.

Is there a specific way to administer Ibuprofen Oral Suspension?

Yes, shake well before using and use only the enclosed dosing cup. Give with food or milk if stomach upset occurs.

What should I do in case of an overdose?

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

How should I store Ibuprofen Oral Suspension?

Store at 68-77°F (20-25°C) and do not freeze.

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 bubblegum flavor to enhance palatability. The therapeutic effects of this formulation can last up to 8 hours. 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 pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

For patients weighing under 24 lbs (under 2 years of age), the recommended dose is to consult a physician. For those weighing between 24-35 lbs (ages 2-3 years), the dose is 5 mL. Patients weighing 36-47 lbs (ages 4-5 years) should receive 7.5 mL, while those weighing 48-59 lbs (ages 6-8 years) should be administered 10 mL. For patients weighing 60-71 lbs (ages 9-10 years), the dose is 12.5 mL, and for those weighing 72-95 lbs (age 11 years), the recommended dose is 15 mL.

Dosing may be repeated every 6-8 hours as needed, but should not exceed four 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 critical to adhere to the recommended dosing guidelines and not exceed the directed amount.

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 immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

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

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

NSAIDs, excluding aspirin, are known to elevate 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 cases of overdose, immediate medical attention is required. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for severe stomach bleeding. The risk of this serious adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs, including aspirin and naproxen. Additionally, prolonged use or exceeding the recommended dosage increases the likelihood of stomach bleeding.

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, and the risk is amplified with higher doses or extended duration of use.

Common adverse reactions may include severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. Such symptoms warrant 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 necessitate immediate medical attention. Furthermore, if the patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical consultation is advised. Redness or swelling in the painful area or the emergence of new symptoms should also prompt a discussion with a healthcare provider.

It is recommended that patients consult a doctor before use if any of the following apply: a history of stomach problems, such as heartburn; previous serious side effects from pain relievers or fever reducers; dehydration due to vomiting or diarrhea; or 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. Additionally, consultation with a healthcare professional is advised for patients under a doctor's care for any serious condition or those taking other medications.

Drug Interactions

Ibuprofen has been associated with an increased risk of gastrointestinal bleeding when co-administered with anticoagulants or corticosteroids. This risk is further elevated in pediatric patients who are concurrently taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin and naproxen.

Healthcare professionals should exercise caution when prescribing ibuprofen alongside these medications and consider monitoring for signs of gastrointestinal bleeding. Dosage adjustments may be necessary based on the clinical scenario and the patient's overall medication regimen.

No specific interactions with laboratory tests 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 doctor. For children aged 2 years and older, dosing is based on weight and age as follows:

  • For children under 24 lbs (under 2 years): consult a doctor.

  • For children weighing 24-35 lbs (2-3 years): administer 5 mL.

  • For children weighing 36-47 lbs (4-5 years): administer 7.5 mL.

  • For children weighing 48-59 lbs (6-8 years): administer 10 mL.

  • For children weighing 60-71 lbs (9-10 years): administer 12.5 mL.

  • For children weighing 72-95 lbs (11 years): administer 15 mL.

It is essential to keep this medication out of reach of children. In the event of an overdose, medical help should be sought immediately, or a Poison Control Center should be contacted.

Before administering this medication, a doctor should be consulted if the child has a history of allergic reactions to ibuprofen or any other pain reliever/fever reducer. A warning for stomach bleeding applies if the child has a history of stomach ulcers or bleeding problems, is taking anticoagulants or steroid drugs, is using other NSAIDs, or exceeds the recommended duration or dosage.

Parents or caregivers should consult a doctor promptly if the child experiences any problems or serious side effects from pain relievers or fever reducers. To minimize stomach upset, the medication may be given with food or milk.

If the child shows no relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, medical advice should be sought. Additionally, if any signs of stomach bleeding or symptoms indicative of heart problems or stroke occur, the use of the medication should be stopped, and a doctor should be consulted.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. Healthcare providers should exercise caution and closely monitor geriatric patients for any adverse effects or complications that may arise due to the lack of specific guidance. It is advisable to assess the individual needs and health status of elderly patients before prescribing this product, as the absence of comprehensive information may necessitate dose adjustments or alternative therapeutic options.

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 nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with adverse fetal outcomes, including potential cardiovascular effects and renal impairment.

Pregnant women are advised to consult a healthcare provider before using ibuprofen to discuss the potential risks and benefits associated with its use during pregnancy.

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, 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 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 liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. Regular assessment of clinical parameters and laboratory values is advised to manage any adverse effects that may arise from 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. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient's vital signs and overall clinical status is recommended to ensure safety and efficacy in treatment.

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 postmarketing surveillance and should be considered when evaluating the safety profile of the product.

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 child experiences stomach upset.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, healthcare providers should inform patients to stop use and seek medical attention 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 be counseled to monitor the child’s response to treatment. If the child does not experience relief within the first 24 hours, or if fever or pain worsens or persists beyond three days, they should contact a healthcare professional. The presence of redness or swelling in the painful area or the emergence of any new symptoms should also prompt a consultation with a doctor.

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if any of the following conditions apply: the child has a history of stomach bleeding, has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, or has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients should be advised to seek medical advice if the child has asthma or is taking a diuretic.

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

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for 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. Proper storage conditions should be ensured to prevent any adverse effects on the product's 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. In the event of an overdose, patients are instructed to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

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.