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Ibuprofen

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
September 6, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule
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 2022
Label revision date
September 6, 2022
Manufacturer
Aurohealth LLC
Registration number
ANDA207753
NDC root
58602-879
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 is a medication available in capsule form, specifically designed to relieve pain and reduce fever. It belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). You can use ibuprofen to temporarily alleviate minor aches and pains caused by headaches, toothaches, backaches, menstrual cramps, muscular aches, the common cold, and even minor arthritis pain.

In addition to its pain-relieving properties, ibuprofen is effective in lowering fever. This makes it a versatile option for managing discomfort and helping you feel better when you're unwell.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and even discomfort from the common cold. It can also help with minor pain associated with arthritis.

In addition to pain relief, this medication is effective in temporarily reducing fever, helping you feel more comfortable when you're not feeling well.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. You should not take more than the directed amount, and it's best to use the smallest effective dose. For adults and children aged 12 years and older, the recommended dosage is to take 1 capsule every 4 to 6 hours as needed while symptoms persist.

If you find that 1 capsule isn't enough to relieve your pain or fever, 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 considering giving this medication to a child under 12 years old, it's essential to consult with a doctor first. Always prioritize your health and safety by following these guidelines.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious health risks. Always consult with your healthcare provider if you have any concerns or questions about your medical history and the use of this medication.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, individuals with a history of stomach ulcers or bleeding issues, and those taking blood thinners or other NSAIDs. Drinking three or more alcoholic beverages daily while using ibuprofen can also increase this risk.

There are also warnings regarding heart attack and stroke, as NSAIDs (excluding aspirin) can elevate these risks, particularly if used in higher doses or for extended periods. You should stop using ibuprofen and consult a doctor if you experience symptoms of stomach bleeding (like faintness, vomiting blood, or black stools), signs of heart problems or stroke (such as chest pain or weakness on one side of the body), or if your pain or fever worsens or lasts longer than expected. If you are pregnant or breastfeeding, it's crucial to consult a healthcare professional before using ibuprofen, especially after 20 weeks of pregnancy, due to potential risks to the unborn child.

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 ibuprofen and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than directed. Additionally, using ibuprofen increases the risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

You should seek emergency medical help if you suspect an overdose or contact a Poison Control Center at 1-800-222-1222. Stop using ibuprofen and consult your doctor if you notice signs of stomach bleeding (like feeling faint, vomiting blood, or having black stools), symptoms of heart problems or stroke (such as chest pain or weakness on one side of the body), or if your pain or fever worsens or lasts longer than expected.

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 unusual 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 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.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before giving them this medication. 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 careful not to exceed six capsules in a 24-hour period unless directed by a doctor. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

As you age, it's important to be aware that the risk of severe stomach bleeding increases if you are 60 years or older. This means that if you or a loved one falls into this age group, extra caution should be taken when using certain medications, especially those that can irritate the stomach.

Always consult with your healthcare provider about the safest options for you, and make sure to discuss any medications you are taking. They can help you understand the risks and adjust dosages if necessary to ensure your safety and well-being.

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.

It's always best to consult with your healthcare provider about your specific situation, as they can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take ibuprofen, it may reduce the effectiveness of aspirin when used for preventing heart attacks or strokes. Additionally, if you are on blood thinners (medications that prevent blood clots) or steroids, using ibuprofen can increase your risk of stomach bleeding.

Moreover, using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen can raise your chances of experiencing serious heart issues, such as heart attacks or strokes, especially if you take them for longer than recommended. Always discuss any medications you are taking with your healthcare provider to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). It's important to avoid exposing it to excessive heat, particularly temperatures above 40°C (104°F), as this can compromise its effectiveness.

When handling the product, always maintain a clean environment to prevent contamination. If there are any specific components included with your product, make sure to follow any additional instructions provided for their use and safety. Proper storage and careful handling will help you get the most out of your product.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using it. Specifically, avoid using ibuprofen after 20 weeks of pregnancy unless your doctor has specifically instructed you to do so, as it may pose risks to your unborn child or lead to complications during delivery.

FAQ

What is Ibuprofen used for?

Ibuprofen is a pain reliever and fever reducer that temporarily relieves minor aches and pains from headaches, toothaches, backaches, menstrual cramps, muscular aches, the common cold, and minor arthritis pain.

How should I take Ibuprofen?

Adults and children 12 years and over should take 1 capsule every 4 to 6 hours while symptoms persist, not exceeding 6 capsules in 24 hours unless directed by a doctor.

What should I do if I experience stomach bleeding?

Stop using Ibuprofen and seek medical help if you experience symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools.

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke, especially if used more than directed.

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Ibuprofen, especially after 20 weeks of pregnancy, as it may cause complications.

What should I do if I have an allergic reaction to Ibuprofen?

If you experience symptoms of a severe allergic reaction, such as hives or difficulty breathing, stop using Ibuprofen and seek emergency medical help immediately.

What is the storage requirement for Ibuprofen?

Store Ibuprofen at 20° to 25°C (68° to 77°F) and avoid excessive heat above 40°C (104°F).

Who should not take Ibuprofen?

Do not use Ibuprofen if you have had an allergic reaction to any other pain reliever/fever reducer or if you are about to undergo heart surgery.

Packaging Info

Below are the non-prescription pack sizes of Ibuprofen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is identified by NDC 58602-879-38 and is manufactured by Primary Health. It contains ibuprofen as the active ingredient, with each capsule delivering a dosage of 200 mg. The formulation serves as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). The product is presented in the form of liquid-filled capsules, with a total of 300 capsules per container. This formulation is comparable to Advil® Liqui-Gels®.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the directed amount. The smallest effective dose should be utilized to manage symptoms effectively.

For adults and children aged 12 years and older, the recommended dosage is 1 capsule every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be administered. However, it is imperative not to exceed a total of 6 capsules within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be administered 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 an increased risk of severe stomach bleeding. The likelihood of such an event is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

NSAIDs, with the exception of aspirin, are also linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in individuals who exceed the recommended dosage or duration of treatment.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult a physician if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke warrant immediate medical evaluation and include chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. Patients should also seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen. 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.

Additionally, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential risk of severe stomach bleeding. This risk is heightened in patients 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 while using the product, or exceed the recommended dosage or duration of use.

The use of NSAIDs, excluding aspirin, is also associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with prolonged use or higher than recommended dosages.

Patients are advised to discontinue use and consult a healthcare professional if they experience any 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, warrant immediate medical attention. Furthermore, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

It is crucial for pregnant or breastfeeding patients to consult a healthcare professional prior to using ibuprofen. The use of ibuprofen is particularly discouraged after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

Ibuprofen may interact with several classes of medications, leading to significant clinical effects that warrant careful consideration.

Interactions with Antiplatelet Agents:Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are taken concurrently for the prevention of heart attack or stroke. It is advisable to avoid the simultaneous use of ibuprofen and aspirin for these indications to ensure optimal therapeutic outcomes.

Interactions with Anticoagulants and Corticosteroids:The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring patients closely for signs of bleeding when these medications are prescribed together. Dose adjustments may be necessary based on the individual patient's risk factors.

Cardiovascular Risks with NSAIDs:The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, is associated with an elevated risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when ibuprofen is used in higher doses or for extended periods. It is recommended that healthcare providers assess the necessity of ibuprofen therapy and consider alternative pain management strategies, especially in patients with pre-existing cardiovascular conditions. Regular monitoring of cardiovascular status may be warranted in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen.
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, 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 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit profile is essential in this population to ensure safe and effective use of the medication.

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 healthcare professional before using this medication while breastfeeding. There is a particular concern regarding the use of ibuprofen during pregnancy, especially after 20 weeks, as it may pose risks to the unborn child and lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for lactating mothers considering this treatment.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, 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 is deemed appropriate based on clinical judgment.

Furthermore, specific antidotes or treatments may be indicated depending on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended for guidance on the management of overdose cases.

Overall, vigilance and prompt intervention are critical in managing potential overdosage situations effectively.

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 regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified a range of adverse reactions reported voluntarily or through surveillance programs. These include gastrointestinal bleeding, renal impairment, and hepatic impairment. Cardiovascular events such as heart attack and stroke have also been noted. Allergic reactions, including anaphylaxis and skin reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported.

Additional adverse reactions include exacerbation of asthma, hypertension, edema, and thrombocytopenia. Cases of aseptic meningitis and liver enzyme elevations have been documented, along with symptoms such as anemia, dizziness, headache, rash, nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, somnolence, fatigue, palpitations, tinnitus, visual disturbances, and hearing disturbances. Skin reactions, including pruritus and urticaria, have also been observed.

These adverse reactions were reported during postmarketing surveillance and may not be directly related to the use of ibuprofen.

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.

Patients who are pregnant or breastfeeding should be encouraged to consult a healthcare professional prior to using this medication. It is particularly crucial to inform patients that ibuprofen should not be used 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.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset, to help mitigate gastrointestinal discomfort.

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 controlled temperature range of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Ibuprofen, 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 Ibuprofen, 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.