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Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
June 27, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet, Coated
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 2012
Label revision date
June 27, 2013
Manufacturer
Polygen Pharmaceuticals LLC
Registration number
ANDA091239
NDC roots
52605-114, 52605-117
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Ibuprofen Tablets, USP 200 mg, are a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that helps relieve pain and reduce fever. You can use ibuprofen to temporarily alleviate minor aches and pains caused by various conditions, including backaches, headaches, menstrual cramps, arthritis, muscular aches, toothaches, and even discomfort from the common cold.

By working to reduce inflammation in the body, ibuprofen effectively helps you feel more comfortable during times of pain or fever. It's comparable to the active ingredient found in Advil®, making it a familiar choice for many seeking relief.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions. This includes discomfort from backaches, headaches, menstrual cramps, minor arthritis pain, muscular aches, and toothaches. It can also help ease the symptoms of the common cold and temporarily reduce fever.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 to 6 hours as needed while you have symptoms. If you find that 1 tablet isn’t enough to relieve your pain or fever, you may take 2 tablets instead. However, it’s important not to exceed 6 tablets in a 24-hour period unless your doctor advises you to do so.

For children under 12 years old, it’s best to consult a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

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 risks to your health.

Be cautious about the dosage; using more than directed or for longer than recommended can increase your risk of heart attack or stroke. Always follow the instructions provided to ensure your safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of a severe allergy may include wheezing (asthma), blisters, facial swelling, hives, rash, shock, and skin reddening. Additionally, this medication is an NSAID (nonsteroidal anti-inflammatory drug) and may increase the risk of stomach bleeding, especially if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume alcohol regularly, or use other NSAIDs.

If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, you should stop using ibuprofen and consult your doctor. It's also important to seek medical advice if your pain worsens or lasts more than 10 days, if your fever persists for more than 3 days, or if you develop any new symptoms. Always talk to your doctor before using ibuprofen if you have a history of stomach issues, high blood pressure, heart disease, kidney disease, or if you are taking other medications.

Warnings and Precautions

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

This medication may also increase the risk of stomach bleeding, particularly if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, use other NSAIDs (like aspirin or naproxen), or consume three or more alcoholic drinks daily while using it. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, stop using ibuprofen and contact your doctor.

In case of an overdose, seek emergency medical assistance or call a Poison Control Center at 1-800-222-1222 right away. Additionally, if your pain worsens or lasts more than 10 days, if your fever worsens or lasts more than 3 days, or if you notice any new symptoms, stop using ibuprofen and consult your doctor.

Overdose

Taking too much ibuprofen can be dangerous and may lead to serious health issues. If you or someone you know has taken an overdose, you might notice symptoms such as nausea, vomiting, stomach pain, drowsiness, headache, or confusion. In more severe cases, an overdose can result in kidney failure, liver damage, or gastrointestinal bleeding (bleeding in the digestive tract).

If you suspect an overdose, it’s crucial to seek emergency medical help right away. Don’t wait for symptoms to worsen; getting prompt treatment can make a significant difference in outcomes. Always prioritize safety and reach out for professional assistance if you have any concerns about ibuprofen use.

Pregnancy Use

It's important to consult with a healthcare professional before using any medication during pregnancy. If you are pregnant or planning to become pregnant, be particularly cautious with ibuprofen. Avoid using it during the last three months of your pregnancy unless your doctor specifically advises you to do so, as it 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 professional guidance.

Lactation Use

Before using ibuprofen while breastfeeding, it's important to consult with a healthcare professional. This is particularly crucial if you are in the last three months of pregnancy, as using ibuprofen during this time can lead to potential issues for the 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 have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet does not relieve pain or fever, you may give 2 tablets. However, be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and seek guidance if you're unsure about the appropriate use for your child.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 years or older, there is an increased risk of stomach bleeding when taking certain drugs. This means that you should be especially cautious and discuss any concerns with your healthcare provider, who can help you understand the risks and determine the best treatment options for your needs.

Always make sure to inform your doctor about your age and any other health conditions you may have, as this information can help them tailor your medication plan to keep you safe and healthy.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always best to discuss your individual situation with your healthcare provider, as they can offer personalized advice and monitor your health closely.

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

Drug Interactions

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

Moreover, using ibuprofen for longer than recommended can raise your chances of experiencing a heart attack or stroke. Always discuss your current medications and any potential interactions with your healthcare provider to ensure your safety and the effectiveness of your treatments.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25 °C (68-77 °F). It's important to check the seal under the cap before use; do not use the product if the seal is broken or missing, as this could compromise its safety and effectiveness. Additionally, make sure to refer to the end panel for the lot number and expiration date to confirm that the product is still within its usable timeframe.

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

Additional Information

No further information is available.

FAQ

What is Ibuprofen Tablets used for?

Ibuprofen Tablets are used as a pain reliever and fever reducer. They temporarily relieve minor aches and pains from conditions like backache, headache, menstrual cramps, and toothache.

What should I do if I experience stomach bleeding?

If you experience symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop use and seek medical help immediately.

How should I take Ibuprofen Tablets?

Adults and children 12 years and older should take 1 tablet every 4 to 6 hours while symptoms persist. Do not exceed 6 tablets in 24 hours unless directed by a doctor.

Are there any contraindications for using Ibuprofen?

Do not use Ibuprofen if you have ever had an allergic reaction to any other pain reliever or if you are using it right before or after heart surgery.

What should I do if I am pregnant?

It is especially important not to use Ibuprofen during the last 3 months of pregnancy unless directed by a doctor, as it may cause problems for the unborn child.

What are the allergy alerts associated with Ibuprofen?

Ibuprofen may cause severe allergic reactions, especially in those allergic to aspirin. Symptoms can include asthma, hives, and facial swelling.

What should I do if I overdose on Ibuprofen?

In case of overdose, get medical help or contact a Poison Control Center immediately.

Can I take Ibuprofen with other medications?

Ask a doctor or pharmacist before using Ibuprofen if you are taking other medications, especially blood thinners or if you are under a doctor's care for any serious condition.

What are the storage instructions for Ibuprofen Tablets?

Store Ibuprofen Tablets between 20-25 °C (68-77 °F) and do not use if the seal under the cap is broken or missing.

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

Ibuprofen Tablets, USP 200 mg, are nonsteroidal anti-inflammatory drug (NSAID) formulations indicated for the relief of pain and reduction of fever. Each bottle contains 100 coated tablets. The product is available under two National Drug Codes (NDC): 52605-114-01 for the tablet formulation and 52605-117-01 for the caplet formulation. These tablets contain ibuprofen as the active ingredient, comparable to that found in Advil®.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dosage of 2 tablets may be administered. It is imperative that the total daily dosage does not exceed 6 tablets 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 for appropriate dosing guidance.

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 asthma (wheezing), blisters, facial swelling, hives, rash, shock, and skin reddening. 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 carries a risk of stomach bleeding. The likelihood of experiencing such adverse effects is heightened in patients who meet any of the following criteria: individuals aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, patients concurrently using anticoagulants or steroid medications, individuals taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents), and those consuming three or more alcoholic beverages daily while using this product. Additionally, prolonged use or exceeding the recommended dosage increases the risk of stomach bleeding.

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

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any of the following symptoms, which may indicate stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, 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, medical advice should be sought promptly.

Side Effects

Patients may experience a range of adverse reactions while using this product, which contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID).

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include asthma (wheezing), blisters, facial swelling, hives, rash, shock, and skin reddening.

Additionally, the use of this NSAID carries a risk of stomach bleeding, which 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 discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other reasons to seek medical advice include worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, the presence of redness or swelling in the painful area, or the emergence of any new symptoms.

Before using this product, patients should consult a doctor if they have a history of serious side effects from pain relievers or fever reducers, have stomach problems such as heartburn, or if the stomach bleeding warning applies to them. Those with high blood pressure, heart disease, kidney disease, liver cirrhosis, or who are taking diuretics should also seek medical advice prior to use. Furthermore, patients under a doctor's care for any serious condition or those taking aspirin for heart attack or stroke should consult a healthcare professional, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

The concomitant use of ibuprofen and aspirin may diminish the cardioprotective effects of aspirin, particularly in patients taking aspirin for the prevention of heart attack or stroke. It is advisable to separate the administration of these medications by at least 8 hours to mitigate this interaction.

Ibuprofen has been associated with an increased risk of gastrointestinal bleeding, especially when used in conjunction with anticoagulants or corticosteroids. Clinicians should exercise caution and consider monitoring for signs of gastrointestinal complications in patients receiving these combinations.

Additionally, prolonged use of ibuprofen beyond the recommended dosage may elevate the risk of cardiovascular events, such as heart attack or stroke. It is essential to adhere to prescribed dosages and duration of therapy to minimize this risk. Regular assessment of the patient's cardiovascular status may be warranted in those requiring extended ibuprofen therapy.

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 and children aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of 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 monitor these patients closely 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 ratio is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. The potential adverse effects on fetal outcomes and the delivery process necessitate careful consideration and professional guidance in managing pain or inflammation during pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless explicitly directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare providers should carefully consider the potential risks and benefits when advising lactating mothers on the use of this medication.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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

Overdosage of ibuprofen can result in significant health risks. Healthcare professionals should be aware of the potential symptoms and management strategies associated with such incidents.

Symptoms of Overdose Patients experiencing an ibuprofen overdose may present with a range of symptoms, including nausea, vomiting, stomach pain, drowsiness, headache, and confusion. These symptoms can vary in severity depending on the amount ingested and the individual’s health status.

In more severe cases, an overdose may lead to critical complications such as kidney failure, liver damage, or gastrointestinal bleeding. These conditions require immediate medical attention and intervention.

Recommended Actions If an overdose is suspected, it is imperative to seek emergency medical help without delay. Prompt assessment and treatment are essential to mitigate the potential for serious harm. Healthcare providers should be prepared to initiate appropriate management protocols based on the severity of the symptoms and the clinical presentation of the patient.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of 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 specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Side effects have been reported in the postmarketing experience. Healthcare professionals and patients are encouraged to report any adverse events to PolyGen at 1-888-291-7337 and/or to the FDA at 1-800-FDA-1088.

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 crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should inform patients that side effects may occur while using the medication. Patients are encouraged to report any side effects they experience to PolyGen at 1-888-291-7337 or to the FDA at 1-800-FDA-1088. This reporting is vital for ongoing safety monitoring and can help ensure that any potential risks are addressed appropriately.

Storage and Handling

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

Healthcare professionals should ensure that the product is not used if the seal under the cap is broken or missing, as this may compromise the safety and quality of the product. For traceability, the lot number and expiration date can be found on the end panel of the packaging. Proper handling and adherence to these storage conditions are crucial for optimal product performance.

Additional Clinical Information

No further data are available.

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.