Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Ibuprofen

Last content change checked dailysee data sync status

Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
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 2017
Label revision date
March 3, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
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 2017
Label revision date
March 3, 2022
Manufacturer
Aurohealth LLC
Registration number
ANDA208865
NDC root
58602-801
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (16 NDCs)
Packaging & NDC Codes (16)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Ibuprofen Tablets USP are a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that come in a 200 mg dosage. They are commonly used to temporarily relieve minor aches and pains, including headaches, muscular aches, toothaches, backaches, and menstrual cramps. Additionally, ibuprofen can help reduce fever and alleviate discomfort associated with the common cold.

This medication works by blocking certain substances in the body that cause inflammation and pain, providing you with relief when you need it most. Whether you're dealing with everyday aches or discomfort from specific conditions, ibuprofen can be a helpful option to consider.

Uses

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

This medication is designed to provide quick relief, making it a helpful option when you're dealing with these common discomforts. 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 caplet every 4 to 6 hours as needed while you have symptoms. If your pain or fever doesn’t improve with just 1 caplet, you may take 2 caplets instead. However, it’s important not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise.

For children under 12 years old, it’s best to consult a doctor before giving any medication. This ensures that the treatment is safe and appropriate for their age and condition. Always follow your healthcare provider's instructions for the best results.

What to Avoid

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

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, especially in those allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

Additionally, ibuprofen carries risks of stomach bleeding, heart attack, and stroke. The risk of stomach bleeding is higher if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume alcohol regularly, or use other NSAIDs. You should stop using ibuprofen and consult a doctor if you notice signs of stomach bleeding (like faintness, vomiting blood, or black stools) or symptoms of heart problems (such as chest pain or trouble breathing). Always talk to your doctor before using ibuprofen if you have existing health issues or 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 the medication and seek medical help immediately.

This medication is an NSAID (nonsteroidal anti-inflammatory drug) and may lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than recommended. Additionally, NSAIDs can increase the risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

You should seek emergency medical assistance if you suspect an overdose or contact a Poison Control Center at 1-800-222-1222. Stop using ibuprofen and consult your doctor if you notice signs of stomach bleeding (like feeling faint, vomiting blood, or having black stools), symptoms of heart problems or stroke (such as chest pain or slurred speech), if your pain worsens or lasts more than 10 days, if your fever persists for more than 3 days, or if you notice any new symptoms.

Overdose

Taking too much ibuprofen can be very harmful. If you or someone you know has taken an overdose, you might notice symptoms such as nausea (feeling sick), vomiting, stomach pain, drowsiness (feeling unusually sleepy), headache, and confusion. In more serious situations, an overdose can lead to kidney failure, liver damage, and gastrointestinal bleeding (bleeding in the stomach or intestines).

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 keep medications out of reach and follow dosing instructions carefully to avoid accidental overdoses.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly important if you are 20 weeks pregnant or later, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always 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 if you are 20 weeks pregnant or later, as using ibuprofen during this time 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 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 one caplet every 4 to 6 hours as needed for symptoms. If one caplet does not relieve pain or fever, you may give two caplets. However, be sure not to exceed six caplets in a 24-hour period unless directed by a healthcare professional. 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 that the risk of severe stomach bleeding increases if you are 60 years or older. This means that if you or a loved one falls into this age group, extra caution should be taken when using certain medications, especially those that can irritate the stomach.

Always consult with your healthcare provider about the safest options for you, and make sure to discuss any medications you are taking to help minimize potential risks. Your health and safety are paramount, so staying informed and proactive is key.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to talk to your healthcare provider before using this medication, especially if you are taking aspirin to prevent heart attacks or strokes. Ibuprofen can reduce the effectiveness of aspirin, which may impact your heart health. Always keep your doctor informed about all the medications you are taking to ensure your treatment is safe and effective.

Storage and Handling

To ensure the safety and effectiveness 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 check the bottle cap before use; do not use the product if the seal marked "SEALED for YOUR PROTECTION" is broken or missing, as this indicates that the product may not be safe. Additionally, always refer to the top panel of the packaging 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

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

FAQ

What is Ibuprofen Tablets USP used for?

Ibuprofen Tablets USP are used to temporarily relieve minor aches and pains due to headaches, muscular aches, arthritis, toothaches, backaches, the common cold, menstrual cramps, and to reduce fever.

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

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

What should I do if I experience an allergic reaction?

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

Are there any warnings associated with taking ibuprofen?

Yes, ibuprofen may cause severe stomach bleeding, especially in individuals over 60 or those with a history of stomach problems. It also increases the risk of heart attack and stroke.

Can I use ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using ibuprofen. It is particularly important not to use it at 20 weeks or later in pregnancy unless directed by a doctor.

What should I do if I take too much ibuprofen?

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

What should I do if I have a history of stomach problems?

If you have a history of stomach problems, such as ulcers or bleeding, consult a doctor before using ibuprofen.

What are the storage conditions for ibuprofen?

Store ibuprofen between 20° to 25°C (68° to 77°F) and do not use it if the seal under the bottle 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 formulated as coated caplets, each containing 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. The product is supplied in a package containing 100 capsule-shaped tablets. The National Drug Code (NDC) for this formulation is 58602-801-21, and it is manufactured by AUROHEALTH.

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 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does not exceed 6 caplets 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 ibuprofen or any other pain reliever or fever reducer. Additionally, it should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of such an event is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

NSAIDs, with the exception of aspirin, are also linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in individuals who use the medication in excess of the recommended dosage or for extended periods.

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

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

Side Effects

Patients may experience a range of adverse reactions associated with the use of 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 hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, patients should discontinue use immediately and seek medical assistance.

The use of this NSAID is also associated with an increased 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 this product, or exceed the recommended dosage or duration of use. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, there is a warning regarding the potential for heart attack and stroke associated with NSAID use, excluding aspirin. The risk of these serious cardiovascular events may increase with higher doses or prolonged use of the medication. Patients should seek medical advice if they experience symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Patients are advised to stop using the product and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever worsens or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using this product, patients should consult a doctor if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended that patients taking aspirin for cardiovascular protection consult a healthcare provider, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Patients should consult a healthcare professional prior to using ibuprofen if they are concurrently taking aspirin for the prevention of heart attack or stroke. The concomitant use of ibuprofen may diminish the cardioprotective effects of aspirin, potentially reducing its efficacy in these clinical scenarios. Monitoring for cardiovascular outcomes may be warranted in patients receiving both medications.

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 caplet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets within 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 this medication to geriatric patients, considering the potential for heightened adverse effects.

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

Pregnancy

Pregnant patients and women of childbearing potential should consult a healthcare professional before using this medication. The use of ibuprofen is particularly cautioned against after 20 weeks of pregnancy, as it may pose risks to the developing fetus and lead to complications during delivery. It is essential that pregnant patients only use ibuprofen if explicitly directed by a healthcare provider.

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 at 20 weeks of gestation or later unless specifically directed by a physician, 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 weigh the potential benefits against the risks when considering this medication for lactating mothers.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

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

Symptoms of Overdose Patients experiencing an overdose may present with a range of symptoms, including nausea, vomiting, stomach pain, drowsiness, headache, and confusion. In more severe cases, the consequences can escalate to critical conditions such as kidney failure, liver damage, and gastrointestinal bleeding.

Recommended Actions In the event of a suspected overdose, it is imperative to seek emergency medical attention immediately. Prompt intervention is crucial to mitigate the risks associated with ibuprofen overdosage and to initiate appropriate management procedures.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Cardiovascular events, including heart attack and stroke, have been noted. Gastrointestinal complications such as bleeding, ulceration, and perforation have also been reported. Instances of renal toxicity, including acute kidney injury, have been documented. Hepatic toxicity, characterized by elevated liver enzymes and liver failure, has been observed as well.

Severe allergic reactions, including anaphylaxis and angioedema, have been recorded. Additionally, skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.

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 taking the medication with food or milk may help alleviate any stomach upset that occurs.

Patients must be instructed to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, they should stop use and seek medical advice if they exhibit symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

It is important for patients to be aware that if their pain worsens or persists for more than 10 days, or if their fever intensifies or lasts longer than 3 days, they should consult a healthcare professional. Patients should also report any redness or swelling in the painful area or the emergence of any new symptoms.

Healthcare providers should encourage patients to consult a doctor before using the medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Patients with a history of stomach issues, such as heartburn, or those for whom the stomach bleeding warning is applicable should also seek medical advice prior to use.

Furthermore, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should be advised to consult a doctor before taking this medication. Those currently taking a diuretic or aspirin for heart attack or stroke should also discuss their use of this medication with a healthcare professional, as ibuprofen may diminish the benefits of aspirin. Lastly, patients under a doctor's care for any serious condition or those taking any other medications should be encouraged to consult a doctor or pharmacist before use.

Storage and Handling

The product is supplied in a container that must be stored at a temperature range of 20° to 25°C (68° to 77°F). It is essential to ensure that the seal imprinted with "SEALED for YOUR PROTECTION" under the bottle cap remains intact; do not use the product if this seal is broken or missing. For identification purposes, the lot number and expiration date can be found on the top panel of the container.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly critical to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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

Last AI update:

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.