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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 2014
Label revision date
November 18, 2014
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 2014
Label revision date
November 18, 2014
Manufacturer
Discount Drug Mart
Registration number
ANDA079129
NDC root
53943-401
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Ibuprofen is a pain reliever and fever reducer that belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It comes in the form of 200 mg tablets and is designed to temporarily relieve minor aches and pains, including headaches, muscular aches, toothaches, backaches, and menstrual cramps. Additionally, ibuprofen can help reduce fever, making it a versatile option for managing discomfort associated with various conditions, such as the common cold and arthritis.

This medication is similar to the active ingredient found in Advil, although it is not manufactured or distributed by Pfizer Inc., the owner of the Advil trademark. If you're looking for a way to alleviate pain or reduce fever, ibuprofen may be a suitable choice for you.

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 go about your day with less pain. Always remember to follow the recommended guidelines for use.

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 of age, 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, or if you are scheduled for heart surgery or have just had one. These conditions can lead to serious health risks.

Additionally, be cautious about how you use this medication. Taking more than the recommended dose or using it for longer than directed can increase your risk of heart attack or stroke. Always follow your healthcare provider's instructions to ensure your safety.

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, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, with a history of stomach ulcers or bleeding, or who are taking blood thinners or other NSAIDs. 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, vomiting blood, having bloody or black stools, 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 a doctor before using ibuprofen if you have a 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 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 ibuprofen immediately and seek medical help. Additionally, ibuprofen 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.

You should stop taking ibuprofen and call your doctor if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Also, contact your doctor if your pain worsens or lasts more than 10 days, if your fever worsens or lasts more than 3 days, if you see redness or swelling in the painful area, or if any new symptoms arise. If you are pregnant or breastfeeding, consult a healthcare professional before using ibuprofen, especially during the last three months of pregnancy.

In case of an overdose, seek emergency medical help or contact a poison control center at 1-800-222-1222 immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have concerns about an overdose.

Pregnancy 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 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 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 isn't enough to relieve pain or fever, you can give 2 tablets. However, make sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise. Always prioritize your child's safety and follow these guidelines closely.

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 that can affect the stomach. Always consult with your healthcare provider about the safest options for you, especially if you have any existing health conditions or are taking other medications. Your safety and well-being are the top priority, so don't hesitate to ask questions and discuss any concerns you may have.

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 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 that certain medications can interact with each other, which may affect how well they work or increase the risk of side effects. For instance, if you take aspirin to prevent heart attacks or strokes, using ibuprofen at the same time may reduce the effectiveness of aspirin. Additionally, ibuprofen can interact with blood thinners (medications that help prevent blood clots) or steroid medications, which could raise the risk of stomach bleeding.

To ensure your safety and the effectiveness of your treatments, always discuss any medications you are taking, including over-the-counter drugs like ibuprofen, with your healthcare provider. They can help you understand potential interactions and adjust your treatment plan as needed.

Storage and Handling

To ensure the best performance and safety 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 packaging before use; do not use the product if the safety seal under the cap is broken or missing, as this indicates it may have been tampered with. Additionally, make sure to look at the end panel for the lot number and expiry date to confirm that the product is still valid for use.

By following these simple storage and handling guidelines, you can help maintain the integrity and effectiveness of the 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 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 that comes in 200 mg tablets. It is classified as a nonsteroidal anti-inflammatory drug (NSAID).

What conditions does Ibuprofen temporarily relieve?

Ibuprofen temporarily relieves minor aches and pains due to headaches, muscular aches, minor arthritis pain, toothaches, backaches, the common cold, and menstrual cramps. It also temporarily reduces fever.

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

Adults and children 12 years and older should take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used, but do not exceed 6 tablets in 24 hours unless directed by a doctor.

What should children under 12 years do before taking Ibuprofen?

Children under 12 years should ask a doctor before using Ibuprofen.

Are there any contraindications for using Ibuprofen?

You should not use Ibuprofen if you have ever had an allergic reaction to any other pain reliever or fever reducer, or if you are about to have or have just had heart surgery.

What are the allergy alerts associated with Ibuprofen?

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

What should you do if you experience signs of stomach bleeding while taking Ibuprofen?

If you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop taking Ibuprofen and call your doctor immediately.

Is it safe to use Ibuprofen during pregnancy?

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

What should you do in case of an overdose of Ibuprofen?

In case of overdose, get medical help or contact a poison control center immediately.

How should Ibuprofen be stored?

Ibuprofen should be stored between 20 – 25°C (68-77°F) and should not be used if the tamper-evident safety 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, are round-shaped, coated tablets containing 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each carton contains 50 tablets. This product is comparable to the active ingredient of Advil; however, it is not manufactured or distributed by Pfizer Inc., the owner of the registered trademark Advil.

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

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 otherwise 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 used 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 carries a risk of severe stomach bleeding. The likelihood of 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 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.

Healthcare professionals should advise patients to discontinue use and consult a physician 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. Additionally, 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 affected area, or if any new symptoms arise.

Pregnant or breastfeeding individuals should consult a healthcare professional prior to using ibuprofen. It is particularly crucial to avoid ibuprofen during the last trimester of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

In cases of overdose, immediate medical attention is required. Patients should contact a poison control center (1-800-222-1222) or seek emergency medical help without delay.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

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

Additionally, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential risk of severe stomach bleeding. The likelihood of this adverse reaction increases in patients who are aged 60 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 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, a 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 ibuprofen, patients should consult a doctor if they have experienced serious side effects from pain relievers or fever reducers, if the stomach bleeding warning is applicable, or if they have a history of stomach problems such as heartburn. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should also seek medical advice prior to use.

Furthermore, patients taking aspirin for cardiovascular protection should be aware that ibuprofen may diminish the effectiveness of aspirin. It is also recommended that individuals under a doctor's care for any serious condition or those taking other medications consult with a healthcare professional or pharmacist before using ibuprofen.

Drug Interactions

The concomitant use of ibuprofen with aspirin, particularly in the context of cardiovascular events such as heart attack or stroke, may diminish the therapeutic efficacy of aspirin. This interaction is significant as it could potentially compromise the intended cardiovascular protective effects of aspirin.

Additionally, ibuprofen has the potential to interact with anticoagulant medications and corticosteroids. Such interactions may elevate the risk of gastrointestinal bleeding. Therefore, careful consideration should be given to the use of ibuprofen in patients who are concurrently receiving these classes of medications. Monitoring for signs of gastrointestinal bleeding is advisable in these cases, and dosage adjustments may be necessary based on the clinical scenario and patient response.

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 children aged 12 years and older, the recommended dosing 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 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing medications that may exacerbate this risk in this population. It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies as necessary to ensure their safety.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen 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.

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 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 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 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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the pharmacological profile of the medication.

Management Procedures In the absence of specific antidotes or treatment protocols, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on managing overdosage cases. It is crucial to document the incident thoroughly and report any adverse effects to the appropriate regulatory authorities as per local guidelines.

Overall, the lack of detailed overdosage information underscores the importance of careful dosing and monitoring of patients receiving this medication.

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 relevant information is available regarding non-teratogenic effects. Additionally, there is no relevant information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Reports of adverse drug events have been received through voluntary reporting and surveillance programs. Individuals are encouraged to report any adverse events to the designated call center at (877) 586-7979.

Patient Counseling

Patients should be advised 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 who are pregnant or breastfeeding to consult a healthcare professional prior to use. Specifically, patients should be informed that the use of ibuprofen during the last three months of pregnancy is not recommended unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Patients experiencing stomach upset should be instructed to take the medication with food or milk to mitigate discomfort.

Additionally, it is important to communicate to patients that exceeding the recommended dosage or prolonging the duration of use may increase the risk of serious cardiovascular events, such as heart attack or stroke.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident seal. It is essential to inspect the safety seal under the cap; do not use the product if the seal is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20 to 25°C (68 to 77°F). Users are advised to check the end panel for the lot number and expiry date to ensure product integrity and safety.

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 three months 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.

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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.