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Proprinal

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
December 4, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule, Liquid Filled
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 2017
Label revision date
December 4, 2024
Manufacturer
HART Health
Registration number
ANDA079205
NDC root
50332-0130
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

This medication is designed to temporarily relieve minor aches and pains, such as those caused by headaches, muscular aches, backaches, minor arthritis pain, the common cold, toothaches, and menstrual cramps. Additionally, it can help reduce fever for a short period. If you're experiencing any of these discomforts, this medication may provide the relief you need.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, muscular aches, backaches, minor arthritis pain, the common cold, toothaches, and menstrual cramps. Additionally, it can help reduce fever for a short period.

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) associated with this medication.

Dosage and Administration

When using this medication, it's important to follow the directions carefully. You should take the smallest effective dose to manage your symptoms. For adults and children aged 12 and older, the recommended dosage is to take 1 capsule every 4 to 6 hours as needed. If your pain or fever doesn’t improve with 1 capsule, you can take 2 capsules. However, make sure not to exceed 6 capsules in a 24-hour period unless your doctor advises otherwise.

If you are giving this medication to a child under 12 years old, it's best to consult with a doctor first. Remember, this medication is taken orally, so you should swallow the capsules with water as needed for symptom relief. Always stick to the recommended dosage to ensure your safety and effectiveness of the treatment.

What to Avoid

You should avoid using this medication if you have ever experienced an allergic reaction to any pain reliever or fever reducer. Additionally, it is important not to take this medication right before or after undergoing heart surgery, as this could pose serious health risks.

Always prioritize your safety by discussing any concerns or questions with your healthcare provider, especially regarding your medical history and any potential interactions with other medications.

Side Effects

You should be aware that ibuprofen can cause serious allergic reactions, particularly if you are allergic to aspirin. Symptoms of such reactions may include hives, blisters, facial swelling, and difficulty breathing. Additionally, ibuprofen is an NSAID (nonsteroidal anti-inflammatory drug) that can lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking certain other medications.

There is also an increased risk of heart attack and stroke associated with NSAIDs like ibuprofen, particularly if used in higher doses or for extended periods. If you experience any signs of an allergic reaction, worsening fever or pain, symptoms of stomach bleeding (such as faintness or bloody stools), or signs of heart problems (like chest pain or difficulty breathing), you should stop using ibuprofen and seek medical attention immediately.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, blisters, facial swelling, and difficulty breathing. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately. Additionally, this medication can lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, or are taking blood thinners or other NSAIDs. Drinking three or more alcoholic beverages daily while using ibuprofen also increases this risk.

It's important to be aware of the potential for heart attack and stroke when using ibuprofen, especially if you take more than the recommended dose or use it for an extended period. You should stop using ibuprofen and contact your doctor if you notice any signs of an allergic reaction, if your fever lasts more than three days, or if your pain persists for more than ten days. Seek medical attention if you experience symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, as well as any new or worsening symptoms, including chest pain or difficulty breathing.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly important if you are 20 weeks pregnant or later, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time can potentially lead to issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

If you are considering this medication for your child, it's important to know that you should consult a doctor before using it for children under 12 years of age. For those aged 12 and older, the recommended dosage is one capsule every 4 to 6 hours as needed for symptoms. If one capsule does not relieve pain or fever, you may give two capsules, but be cautious not to exceed six capsules in a 24-hour period unless directed by a doctor.

Always ensure you follow these guidelines to keep your child safe and to manage their symptoms effectively. If you have any concerns or questions, don't hesitate to reach out to a healthcare professional for advice.

Geriatric Use

As you age, it's important to be aware of certain health risks when taking medications. If you are 60 years or older, there is a higher chance of experiencing severe stomach bleeding. This risk is especially significant if you have a history of stomach ulcers or bleeding problems, or if you have conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or have previously had a stroke.

Before starting any new medication, it's wise to consult with your doctor, particularly if any of these warnings apply to you. Your healthcare provider can help ensure that the medication is safe and appropriate for your specific health needs.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to be aware that taking ibuprofen can affect how other medications work, especially if you're using aspirin for heart attack or stroke prevention. Ibuprofen may reduce the effectiveness of aspirin in these situations. Additionally, combining ibuprofen with blood thinners (medications that prevent blood clots) or steroids can increase your risk of stomach bleeding. The same risk applies if you take ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen.

If you have certain health conditions, such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, your use of ibuprofen may need to be carefully managed. Always discuss any medications you are taking, including over-the-counter drugs, with your healthcare provider to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best quality and safety of your product, store it in a cool, dry place at a temperature between 59°F and 86°F (15°C to 30°C). It's important to keep it away from excessive heat and humidity, as these conditions can affect its effectiveness.

When handling the product, always check the packet before use. If the packet is torn, cut, or open, do not use it. The caplets are enclosed in a sealed packet to maintain their integrity, so make sure to keep them in this packaging until you are ready to use them.

Additional Information

No further information is available.

FAQ

What is the general use of this drug?

This drug temporarily relieves minor aches and pains, including headaches, muscular aches, backaches, minor arthritis pain, toothaches, menstrual cramps, and discomfort from the common cold.

How should I take this medication?

You should take 1 capsule every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 capsule, you may take 2 capsules, but do not exceed 6 capsules in 24 hours unless directed by a doctor.

Are there any warnings I should be aware of?

Yes, this medication may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if you have a history of these conditions.

What should I do if I experience an allergic reaction?

If an allergic reaction occurs, stop using the medication and seek medical help immediately.

Can I use this medication if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use. It is especially important not to use this medication at 20 weeks or later in pregnancy unless directed by a doctor.

What should I do if my symptoms worsen?

If your fever worsens or lasts more than 3 days, or if your pain worsens or lasts more than 10 days, stop using the medication and consult a doctor.

What are the storage instructions for this medication?

Store the medication at 59° to 86°F (15°-30°C) and avoid excessive heat and humidity. Do not use if the packet is torn, cut, or open.

Packaging Info

Below are the non-prescription pack sizes of Proprinal (ibuprofen capsules 200 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Proprinal.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Proprinal is represented by the image file Proprinal.jpg, which is in JPEG format. The media type associated with this file is image/jpeg.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

The medication should be administered orally. Adults and children aged 12 years and older are advised to take 1 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, a dose of 2 capsules may be taken. However, it is imperative that no more than 6 capsules are consumed within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor prior to administration. The smallest effective dose should always be utilized, and patients should not exceed the recommended dosage.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer, due to the potential for severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks related to surgical recovery and cardiovascular stability.

Warnings and Precautions

Ibuprofen is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

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

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. This risk is heightened in patients who meet any of the following criteria: those aged 60 years or older, individuals with a history of stomach ulcers or bleeding disorders, patients concurrently using anticoagulants or steroid medications, those taking other NSAIDs (including aspirin, ibuprofen, or naproxen), individuals consuming three or more alcoholic beverages daily while using this product, or those who exceed the recommended dosage or duration of use.

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use ibuprofen in excess of the recommended dosage or for extended periods.

Monitoring and Consultation Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: an allergic reaction, fever that worsens or persists beyond three days, pain that worsens or lasts more than ten days, signs of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), the emergence of new symptoms, the presence of redness or swelling, or symptoms indicative of heart problems or stroke (including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling).

Regular monitoring and patient education regarding these warnings and precautions are essential to mitigate risks associated with ibuprofen use.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, including severe allergic reactions, gastrointestinal bleeding, and cardiovascular events.

Severe allergic reactions may occur, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, blisters, shock, facial swelling, asthma (wheezing), rash, and skin reddening. In the event of an allergic reaction, patients are advised to seek medical assistance immediately.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently. Patients should be vigilant for signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain.

Additionally, the use of NSAIDs, excluding aspirin, has been associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who exceed the recommended dosage or duration of use.

Patients are advised to discontinue use and consult a healthcare provider if they experience any of the following: an allergic reaction, worsening fever lasting more than three days, worsening pain lasting more than ten days, new symptoms, redness or swelling, or symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Drug Interactions

Ibuprofen may interact with several classes of medications, leading to significant clinical effects.

Pharmacodynamic Interactions

  • Aspirin: The concurrent use of ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable to separate the administration of these medications to optimize the therapeutic benefit of aspirin.

  • Anticoagulants and Steroids: The combination of ibuprofen with blood-thinning agents (anticoagulants) or steroid medications increases the risk of gastrointestinal bleeding. Close monitoring for signs of bleeding is recommended when these drugs are used together.

  • Other NSAIDs: The use of ibuprofen in conjunction with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin and naproxen, heightens the risk of stomach bleeding. It is prudent to avoid the concurrent use of multiple NSAIDs.

Pharmacokinetic Considerations

The efficacy and safety of ibuprofen may be influenced by underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Patients with these conditions should be closely monitored, and dosage adjustments may be necessary based on individual clinical status.

Packaging & NDC

Below are the non-prescription pack sizes of Proprinal (ibuprofen capsules 200 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Proprinal.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, a dose of 2 capsules may be administered. It is important to note that the maximum dosage should not exceed 6 capsules within a 24-hour period, unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially if they have a history of stomach ulcers or bleeding problems.

Before initiating treatment, healthcare providers should inquire about any relevant medical history, including conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Given the heightened risk of adverse effects in this population, careful monitoring and consideration of dose adjustments may be warranted to ensure patient safety.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of ibuprofen at 20 weeks of pregnancy or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist is recommended for guidance on the appropriate management strategies.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose to mitigate potential complications and ensure patient safety.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of ibuprofen. Reports have included gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Additionally, serious cardiovascular events, such as myocardial infarction and stroke, have been reported. Instances of severe allergic reactions, including anaphylaxis and angioedema, have also been documented. Furthermore, skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been noted. Postmarketing surveillance has indicated an increased risk of gastrointestinal complications in patients with a history of peptic ulcer disease or gastrointestinal bleeding.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be cautioned against using this medication if they have a history of allergic reactions to any pain reliever or fever reducer. Additionally, it should not be used right before or after heart surgery.

Patients should be informed to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, if fever worsens or persists for more than three days, or if pain worsens or lasts longer than ten days. They should also be advised to seek medical attention if they notice any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, patients should be instructed to stop use and consult a doctor if new symptoms arise, if redness or swelling occurs, or if they experience symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. It is important for patients to consult a doctor before use if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them.

Patients should also be encouraged to discuss their medical history with their healthcare provider, particularly if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Those taking diuretics or any other medications, including aspirin for heart attack or stroke, should seek advice from a doctor or pharmacist before using this product, as ibuprofen may reduce the effectiveness of aspirin. Lastly, patients under a doctor's care for any serious condition should also consult their healthcare provider or pharmacist prior to use.

Storage and Handling

The product is supplied in sealed packets containing caplets. Each packet must be inspected prior to use; do not use if the packet is torn, cut, or open.

For optimal storage, maintain the product at a temperature range of 59° to 86°F (15° to 30°C). It is essential to avoid exposure to excessive heat and humidity to ensure the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Proprinal, 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 Proprinal, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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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.