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Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 200 mg
Other brand names
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 2010
Label revision date
December 17, 2012
Active ingredient
Ibuprofen 200 mg
Other brand names
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 2010
Label revision date
December 17, 2012
Manufacturer
Shopko Stores Operating Co. , LLC.
Registration number
ANDA078682
NDC root
37012-199
Packaging Info
Packaging & NDC Codes

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Drug Overview

Ibuprofen is a medication available in 200 mg capsules that serves as a pain reliever and fever reducer. It belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). You can use ibuprofen to temporarily relieve minor aches and pains caused by headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. Additionally, it helps to temporarily reduce fever, making it a versatile option for managing discomfort and illness.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, muscular aches, arthritis pain, 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

When using this medication, it's important to follow the instructions carefully. You should take the smallest effective dose, which means using the least amount that helps relieve your symptoms. 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're considering this medication for a child under 12 years old, it's best to consult with a doctor first. Remember to take the capsules by mouth, and only use them as directed to ensure your safety and effectiveness of the treatment.

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 allergic reaction may include hives, facial swelling, wheezing (asthma), 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, and those taking blood thinners or other NSAIDs (nonsteroidal anti-inflammatory drugs). Drinking three or more alcoholic beverages daily while using ibuprofen can also increase this risk.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or persistent stomach pain. If your pain worsens or lasts more than 10 days, or if you develop a fever that lasts more than three days, seek medical advice. It's important to talk to your doctor before using ibuprofen if you have any history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if you are taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen immediately and seek medical help. Additionally, this medication can lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than directed.

Before using ibuprofen, consult your doctor if any of the stomach bleeding warnings apply to you, or if you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It's also important to talk to your doctor if you are taking aspirin for heart conditions, as ibuprofen may reduce its effectiveness. If you suspect an overdose, seek emergency medical assistance or contact a Poison Control Center right away. Stop taking ibuprofen and call your doctor if you notice signs of stomach bleeding, 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.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Don’t wait to see if symptoms improve; prompt action can be vital. Always prioritize your health and safety by reaching out for professional assistance in these situations.

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 during the last three months of pregnancy, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always seek guidance from your doctor to ensure the safety of both you and your baby.

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 are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. 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 take two capsules, but be sure not to exceed six capsules in a 24-hour period unless directed by a doctor. Always prioritize safety and consult with a healthcare professional if you have any questions or concerns about your child's health.

Geriatric Use

As you age, it's important to be aware of certain risks when taking medications, especially those containing nonsteroidal anti-inflammatory drugs (NSAIDs). These medications can increase the risk of severe stomach bleeding, particularly if you are 60 years or older. If you have any concerns about this risk, or if you have conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, it's essential to consult your doctor before using these products.

Always prioritize your health by discussing any potential risks with your healthcare provider, especially if you fall into these categories. They can help you determine the safest options for managing your pain or inflammation.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or asthma. Your healthcare provider can help determine if this medication is safe for you and whether any adjustments to your dosage or monitoring are necessary. Always prioritize your health by discussing any concerns with your doctor.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to consult your doctor before using this medication. Your healthcare provider will assess your overall health and any other conditions you may have, including high blood pressure, heart disease, kidney disease, or asthma, to ensure that this medication is safe for you. Always prioritize open communication with your doctor about your liver health to receive the best care possible.

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, if you have an allergy to aspirin, taking ibuprofen could trigger a severe allergic reaction.

You should also know that combining ibuprofen with blood thinners (medications that prevent blood clots), steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen can increase the risk of stomach bleeding. Always consult your healthcare provider before starting any new medication, especially if you are already taking other drugs, 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° 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 damage the product. Additionally, keep it protected from light to maintain its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to prevent contamination. Following these guidelines will help ensure the product remains safe and effective for your use.

Additional Information

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using this medication. 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 Ibuprofen?

Ibuprofen is a pain reliever and fever reducer available in 200 mg capsules.

What conditions does Ibuprofen temporarily relieve?

Ibuprofen temporarily relieves minor aches and pains from headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps.

How should I take Ibuprofen?

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

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use. Avoid using Ibuprofen during the last 3 months of pregnancy unless directed by a doctor.

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

Stop using Ibuprofen and call your doctor if you experience faintness, bloody or black stools, vomit blood, or have stomach pain that does not improve.

Are there any allergies associated with Ibuprofen?

Ibuprofen may cause a severe allergic reaction, especially in those allergic to aspirin. Symptoms can include hives, facial swelling, and difficulty breathing.

What precautions should I take before using Ibuprofen?

Ask a doctor before use if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

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

If you experience an allergic reaction, stop using Ibuprofen and seek medical help immediately.

How should I store Ibuprofen?

Store Ibuprofen at 20° to 25°C (68° to 77°F) and protect it from excessive heat and light.

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

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, 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

The medication should be administered orally, with capsules taken every 4 to 6 hours as needed while symptoms persist. For adults and children aged 12 years and older, the recommended dosage is 1 capsule per administration. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be taken. It is imperative that the total dosage does not exceed 6 capsules within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor before 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 other pain reliever or fever reducer. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may cause 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. 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 severe stomach bleeding. The likelihood of experiencing this adverse effect is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, 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.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: the patient is at risk for stomach bleeding, has experienced serious side effects from pain relievers or fever reducers, has a history of gastrointestinal issues such as heartburn, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or is taking a diuretic. Additionally, patients should be counseled to seek guidance from a doctor or pharmacist if they are under medical care for any serious condition, are taking aspirin for cardiovascular protection, as ibuprofen may diminish the cardioprotective effects of aspirin, or are using any other medications.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, 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 associated with the use of ibuprofen. Serious adverse reactions include severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters.

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.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs indicative of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Other concerning symptoms that warrant medical attention include worsening pain lasting more than 10 days, a fever that worsens or persists beyond three days, redness or swelling in the painful area, or the emergence of any new symptoms.

Before using ibuprofen, patients should seek medical advice if they fall into any of the categories that heighten the risk of stomach bleeding, have experienced serious side effects from pain relievers or fever reducers, have a history of stomach issues such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended to consult a healthcare provider if the patient is under treatment for any serious condition or is taking aspirin for cardiovascular protection, as ibuprofen may diminish the effectiveness of aspirin in these cases.

Drug Interactions

The concomitant use of aspirin and ibuprofen may diminish the cardioprotective effects of aspirin, particularly in patients using aspirin for the prevention of heart attack or stroke. It is advisable to separate the administration of these medications to optimize their therapeutic benefits.

Patients with a known allergy to aspirin should exercise caution when using ibuprofen, as it may precipitate a severe allergic reaction.

The risk of gastrointestinal bleeding is significantly increased when ibuprofen is used in conjunction with anticoagulants, steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Close monitoring for signs of gastrointestinal bleeding is recommended in these scenarios.

Patients are encouraged to consult a healthcare professional prior to initiating ibuprofen if they are currently taking any other medications, to ensure safe and effective use.

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. If pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important not to exceed 6 capsules in 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 of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). It is crucial for healthcare providers to assess the individual risk factors for stomach bleeding in geriatric patients prior to prescribing this medication.

Before initiating treatment, healthcare providers should inquire about the presence of any conditions that may heighten the risk of adverse effects. Specifically, patients with a history of high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should be closely monitored. It is advisable for elderly patients to consult with their healthcare provider to determine the appropriateness of this medication in light of their medical history and current health status.

Due to the potential for serious gastrointestinal complications, careful consideration and monitoring are essential when prescribing this NSAID to geriatric patients.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. The use of ibuprofen during the last trimester is contraindicated 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 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 provided regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or asthma. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's overall health status and the severity of their kidney disease.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function tests may be warranted to ensure appropriate management and to mitigate potential risks associated with the use of this medication in individuals with hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted interventions may be employed to counteract the effects of the overdose.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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 non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to inform patients that they should not use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after undergoing heart surgery.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Patients should also be advised to stop use and seek medical advice if their pain worsens or lasts longer than 10 days, if their fever worsens or persists for more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, patients should be informed to take it with food or milk if they experience stomach upset. It is crucial to communicate that the risk of heart attack or stroke may increase if the medication is used in excess of the recommended dosage or for an extended period.

Patients should be encouraged to consult a doctor before use if the warning regarding stomach bleeding is applicable to them. They should also be advised to seek medical guidance if they have experienced problems or serious side effects from pain relievers or fever reducers in the past, or if they have a history of stomach issues such as heartburn. Furthermore, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should be directed to consult a doctor prior to use.

Patients taking diuretics or those under a doctor's care for any serious condition should also be advised to consult a doctor or pharmacist before using this medication. Additionally, patients should be informed to seek advice from a healthcare professional if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin. Lastly, patients should be encouraged to consult a doctor or pharmacist before use if they are taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures above 40°C (104°F). Additionally, the product must be protected from light to maintain its integrity and efficacy.

Additional Clinical Information

Patients should be advised to consult a healthcare professional if they are pregnant or breastfeeding before using the medication. It is particularly crucial 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 unborn child or lead to complications during delivery.

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.