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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
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
July 30, 2010
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet
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 2010
Label revision date
July 30, 2010
Manufacturer
Contract Pharmacy Services-PA
Registration number
ANDA072096
NDC root
67046-302
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 comes in 200 mg tablets and is designed to temporarily relieve minor aches and pains. You can use it for various discomforts, including muscular aches, minor arthritis pain, toothaches, backaches, and menstrual cramps. Additionally, it helps reduce fever and can be beneficial when you're feeling unwell due to the common cold.

By targeting the sources of pain and discomfort, this medication provides relief, allowing you to feel more comfortable during everyday activities. Always consult with a healthcare professional for personalized advice and to ensure it's the right choice for your needs.

Uses

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

This medication is designed to provide you with comfort when dealing with these common discomforts, allowing you to feel better and carry on with your daily activities.

Dosage and Administration

You can take this medication orally (by mouth) if you are an adult or a child aged 12 years and older. The recommended dose is 1 tablet every 4 to 6 hours as needed while you have symptoms. If your pain or fever doesn’t improve with 1 tablet, you may take 2 tablets instead. However, it’s important not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise.

For children under 12 years, it’s best to consult a doctor before giving them this medication. Always use the smallest effective dose and avoid taking it for more than 10 days unless directed by a healthcare professional. Remember, taking more than the recommended amount can be harmful, so stick to the guidelines provided.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to any pain reliever or fever reducer, or if you are about to undergo heart surgery or have just had one. Be aware that this medication can cause severe allergic reactions, especially in individuals 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 immediately and seek medical help.

Additionally, using this medication in higher doses or for longer than recommended can increase your risk of serious health issues, such as heart attack or stroke. It’s also important to note that this product contains a nonsteroidal anti-inflammatory drug (NSAID), which can 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 other NSAIDs. Always follow the directions carefully to minimize these risks.

Side Effects

You should be aware that this medication can cause serious side effects. If you have ever had an allergic reaction to pain relievers or fever reducers, or if you are about to undergo heart surgery, you should not use this product. It may lead to severe allergic reactions, especially if you are allergic to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. If you experience any of these symptoms, stop using the medication and seek medical help immediately.

Additionally, this medication carries a risk of 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 other NSAIDs (nonsteroidal anti-inflammatory drugs). You should stop using the medication and consult a doctor if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Warnings and Precautions

You should avoid using this medication if you have ever had an allergic reaction to any pain reliever or fever reducer, or if you are scheduled for heart surgery. Be aware that this product contains ibuprofen, which can cause severe allergic reactions, especially in those allergic to aspirin. Symptoms of an allergic reaction 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 increase the risk of serious 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. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, stop taking the medication and contact your doctor. Additionally, if you are taking aspirin for heart protection, consult your doctor before using ibuprofen, as it may reduce the effectiveness of aspirin. In case of an overdose, seek emergency medical help or contact a Poison Control Center 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 breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. During the last three months of pregnancy, you should avoid using ibuprofen unless your doctor specifically advises you to do so, as it 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 professional guidance.

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 during the last three months of pregnancy, as using ibuprofen at this stage 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 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, but be careful not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

As you age, it's important to be aware of certain risks when taking medications like ibuprofen. If you are 60 years or older, the risk of severe stomach bleeding increases. To help prevent stomach upset, consider taking ibuprofen with food or milk.

When using ibuprofen, it's best to use the smallest effective dose and avoid taking it for more than 10 days unless your doctor advises otherwise. Always consult with your healthcare provider if you have any concerns or questions about your medication.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have about taking this medication with your liver condition. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to be aware that taking ibuprofen can reduce the effectiveness of aspirin when it's used to help prevent heart attacks or strokes. This means that if you're relying on aspirin for heart health, you should discuss your use of ibuprofen with your healthcare provider.

Additionally, if you're taking blood thinners (medications that help prevent blood clots) or steroids, or if you're using other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen, the risk of stomach bleeding increases. Always talk to your healthcare provider about all the medications you are taking to ensure your safety and the best possible outcomes for your health.

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 keep it away from high humidity and avoid exposing it to excessive heat, which can be anything above 40°C (104°F).

When handling the product, make sure to do so 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. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using it. Specifically, avoid using ibuprofen during the last three months of pregnancy unless your doctor has specifically instructed you to do so, as it may lead to issues for the unborn child or complications during delivery.

FAQ

What is the general description of this drug?

This drug is available in 200 mg tablets.

What conditions does this drug temporarily relieve?

It temporarily relieves minor aches and pains due to muscular aches, minor arthritis pain, toothache, backache, the common cold, and menstrual cramps. It also temporarily reduces fever.

What is the recommended dosage for adults and children 12 years and older?

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

What should children under 12 years do?

Children under 12 years should ask a doctor before use.

What precautions should I take regarding stomach issues?

If stomach upset occurs, take the drug with food or milk. The risk of stomach bleeding may increase if you take more than directed or for longer than directed.

Are there any contraindications for using this drug?

Do not use this drug if you have ever had an allergic reaction to any other pain reliever or fever reducer, or right before or after heart surgery.

What should I do if I experience signs of stomach bleeding?

Stop use and ask a doctor if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve.

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

If you are pregnant or breastfeeding, ask a health professional before use. It is especially important not to use it during the last 3 months of pregnancy unless directed by a doctor.

What storage conditions are recommended for this drug?

Store the drug at 20-25°C (68-77°F) and avoid high humidity and excessive heat above 40°C (104°F).

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

The product is formulated as 200 mg tablets. Each tablet contains the active ingredient in a solid dosage form, designed for oral administration. The tablets are characterized by their specific weight and dimensions, ensuring accurate dosing and ease of use.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including muscular aches, minor pain of arthritis, toothache, backache, the common cold, 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

Adults and children aged 12 years and older are advised to take 1 tablet orally every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. It is imperative that the total 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, consultation with a doctor is recommended prior to administration.

Healthcare professionals should emphasize the importance of adhering to the prescribed dosage and not exceeding the recommended limits. The smallest effective dose should be utilized, and treatment should not extend beyond 10 days unless otherwise directed by a physician.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to any pain reliever or fever reducer should not use this product, as it may trigger severe allergic responses, including hives, facial swelling, asthma, shock, skin reddening, rash, or blisters.

Additionally, the product should not be used immediately before or after heart surgery due to potential complications.

Caution is advised as this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding, particularly in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroids, are using other NSAIDs, or consume three or more alcoholic beverages daily while using this product.

Warnings and Precautions

The use of this product is contraindicated in individuals with a history of allergic reactions to any pain reliever or fever reducer. It is also advised against use immediately before or after heart surgery.

Allergy Alert Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Should any of these symptoms occur, it is imperative to discontinue use and seek immediate medical assistance.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect 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 blood-thinning medications (anticoagulants) or steroid drugs, individuals taking other NSAIDs (including aspirin, ibuprofen, naproxen, or others), those consuming three or more alcoholic beverages daily while using this product, or patients who exceed the recommended dosage or duration of use.

General Precautions Healthcare professionals should advise patients to consult a physician prior to use if they are currently taking aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin. Additionally, patients under medical supervision for serious health conditions or those taking other medications should seek medical advice before using this product.

In the event of an overdose, it is crucial to obtain medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Monitoring for Adverse Effects Patients should be instructed to discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Furthermore, if fever worsens or persists beyond three days, or if redness or swelling occurs in the affected area, or if any new symptoms arise, medical advice should be sought promptly.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions. Notably, the use of this medication is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer, as well as in those undergoing heart surgery.

A significant concern is the risk of severe allergic reactions, particularly in patients with known allergies to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are 60 years of age or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood thinners or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. Patients should also be cautious if they are taking other medications that contain NSAIDs, such as aspirin, ibuprofen, or naproxen, or if they exceed the recommended dosage or duration of use.

Patients are advised to stop using the product and consult a healthcare professional if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additional symptoms warranting medical consultation include worsening pain lasting more than 10 days, fever persisting for more than three days, redness or swelling in the painful area, or the emergence of any new symptoms.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable for patients to consult their healthcare provider regarding the concurrent use of these medications to ensure optimal therapeutic outcomes.

Additionally, the concomitant use of ibuprofen with anticoagulants, steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin or naproxen increases the risk of gastrointestinal bleeding. Patients receiving these combinations should be closely monitored for signs of gastrointestinal complications, and dosage adjustments may be necessary based on individual risk factors and clinical judgment.

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 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding when using this medication. Therefore, caution is advised when prescribing to this population.

To mitigate the risk of gastrointestinal upset, it is recommended that ibuprofen be taken with food or milk. Additionally, healthcare providers should ensure that the smallest effective dose is utilized for geriatric patients. It is also important to advise that the duration of use should not exceed 10 days unless directed by a physician, to further minimize potential adverse effects.

Close monitoring of elderly patients is essential to ensure safety and efficacy while using this medication.

Pregnancy

Pregnant patients and women who are breastfeeding 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. Healthcare providers should carefully consider the potential benefits and risks when prescribing this medication to pregnant patients, especially in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare provider, 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 ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating individuals.

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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

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

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been reported, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking blood-thinning (anticoagulant) or steroid medications, individuals using other drugs containing prescription or nonprescription NSAIDs, and those consuming three or more alcoholic drinks daily while using this product, or taking it for longer than directed.

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 should be informed that if they experience any signs of an allergic reaction, they must stop using the product and seek medical help without delay.

It is important for healthcare providers to instruct patients to discontinue use and consult a doctor if they notice any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if the pain worsens or persists for more than 10 days. Patients should also be made aware that if their fever worsens or lasts more than 3 days, or if redness or swelling occurs in the painful area, they should seek medical advice. Additionally, any new symptoms that arise should prompt a consultation with a healthcare professional.

Patients should be counseled to take the product with food or milk if they experience stomach upset. It is crucial to inform patients that using more than the recommended dose or using the product for an extended period may increase the risk of heart attack or stroke.

Healthcare providers should encourage patients to consult with their doctor before using the product if they are taking aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin. Furthermore, patients under a doctor's care for any serious condition or those taking other medications should also seek medical advice prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to avoid exposure to high humidity and excessive heat, with temperatures not exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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.