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Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 200
Other brand names
Dosage form
Tablet, Film 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 2019
Label revision date
March 27, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200
Other brand names
Dosage form
Tablet, Film 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 2019
Label revision date
March 27, 2019
Manufacturer
ADVANCED FIRST AID, INC.
Registration number
ANDA091239
NDC root
67060-002
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Drug Overview

ADVANCED IBUPROFEN is a medication designed to temporarily relieve minor aches and pains, including headaches, muscular aches, backaches, toothaches, menstrual cramps, and pain associated with arthritis. It can also help alleviate discomfort from the common cold and is effective in reducing fever.

This medication works by blocking certain substances in the body that cause pain and inflammation, providing you with relief when you need it most.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, muscular aches, backaches, toothaches, and menstrual cramps. It can also help with minor arthritis pain and discomfort associated with the common cold. Additionally, this medication is effective in temporarily reducing fever.

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

Dosage and Administration

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

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

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no known reasons that would prevent you from using it safely.

However, it's always important to consult with your healthcare provider before starting any new medication to ensure it’s appropriate for your individual health needs. If you have any concerns or questions about this medication, don’t hesitate to reach out to your doctor or pharmacist for guidance.

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, asthma (wheezing), shock, skin reddening, and blisters. If you experience any of these symptoms, stop using the medication and seek medical help immediately.

Additionally, ibuprofen, which is a nonsteroidal anti-inflammatory drug (NSAID), may lead to stomach bleeding, especially if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume alcohol regularly, or use other NSAIDs. There is also an increased risk of heart attack and stroke associated with NSAIDs, particularly if used in higher doses or for extended periods. If you notice worsening pain or fever, new symptoms, or signs of stomach bleeding (like faintness, vomiting blood, or black stools), or if you experience symptoms of heart problems or stroke (such as chest pain or weakness), contact your doctor right away.

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, or blisters. If you experience any of these symptoms, stop using ibuprofen immediately and seek medical help.

This medication is a nonsteroidal anti-inflammatory drug (NSAID) and may increase the risk of stomach bleeding, particularly if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than recommended. Additionally, NSAIDs can raise the risk of heart attack and stroke, especially if used in higher doses or for extended periods. Avoid using ibuprofen if you have had an allergic reaction to pain relievers or if you are about to undergo heart surgery.

You should stop using ibuprofen and consult your doctor if your pain worsens or lasts more than 10 days, your fever persists for more than 3 days, you notice redness or swelling in the painful area, or if any new symptoms arise. Seek immediate medical attention if you experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Also, watch for symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

Overdose

Taking too much ibuprofen can lead to serious health issues. If you or someone you know has taken an overdose, it's important to be aware of the symptoms, which may include nausea, vomiting, headache, dizziness, and drowsiness. In more severe cases, an overdose can cause gastrointestinal bleeding, kidney failure, and slowed breathing (respiratory depression).

If you suspect an overdose, seek emergency medical help right away. It's crucial to act quickly to ensure safety and receive the appropriate care. Always remember that when it comes to medication, it's better to be cautious and get help if you're unsure.

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 may 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 your baby's well-being by seeking guidance from your doctor.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before giving them this medication. For those aged 12 and older, you should follow the dosing instructions carefully. The smallest effective dose is recommended, which means you should start with 1 tablet every 4 to 6 hours as needed for symptoms. If pain or fever doesn't improve with 1 tablet, you can give 2 tablets, but be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Geriatric Use

As you age, it's important to be aware of certain health considerations when taking medications. If you are 60 or older, the risk of stomach bleeding increases, so it's crucial to be cautious. Before using any pain relievers or fever reducers, consult your doctor, especially if you have experienced serious side effects from these medications in the past or if you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or have had a stroke.

Taking these precautions can help ensure your safety and well-being as you manage your health. Always keep your healthcare provider informed about your medical history and any medications you are taking.

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), asthma, or a history of stroke. Your doctor 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 your medical history with your healthcare provider.

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 may need to adjust your dosage or monitor your condition more closely. This is crucial to ensure your safety and the effectiveness of the treatment. Always keep your doctor informed about any existing health issues, including high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these can also affect your treatment plan.

Drug Interactions

It's important to be aware that taking ibuprofen can reduce the effectiveness of aspirin, especially if you're using aspirin to prevent heart attacks or strokes. This means that if you are prescribed aspirin for these serious health issues, you should discuss any use of ibuprofen with your healthcare provider.

Always talk to your doctor or pharmacist about all the medications you are taking, including over-the-counter drugs like ibuprofen. This way, you can ensure that your treatments work effectively and safely together.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to protect it from light and keep the container tightly closed when not in use. Always keep the product out of reach of children to prevent accidental ingestion or misuse. Once opened, please remember to discard the product to maintain safety and quality.

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 instructed you to do so, as it may lead to issues for the unborn child or complications during delivery.

FAQ

What is ADVANCED IBUPROFEN used for?

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

What should adults and children 12 years and older do for dosing?

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 of age do?

Children under 12 years of age should ask a doctor before use.

Are there any warnings associated with ADVANCED IBUPROFEN?

Yes, there are several warnings, including the risk of severe allergic reactions, stomach bleeding, and increased risk of heart attack and stroke. You should stop use and seek medical help if you experience symptoms like chest pain or bloody stools.

What should I do 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 ibuprofen during the last 3 months of pregnancy unless directed by a doctor.

How should I store ADVANCED IBUPROFEN?

Store ADVANCED IBUPROFEN at room temperature, between 20°C to 25°C (68°F to 77°F), protect it from light, and keep the container tightly closed and out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Ibuprofen (ibuprofen 200mg). 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

ADVANCED IBUPROFEN is a pharmaceutical formulation of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) used for its analgesic, antipyretic, and anti-inflammatory properties. The chemical formula for ibuprofen is C13H18O2, with a molecular weight of 206.28 g/mol. This formulation is available in a dosage form suitable for oral administration. The product is characterized by its white to off-white appearance, indicating the purity and quality of the active ingredient.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor pain of arthritis, toothache, menstrual cramps, and discomfort related to the common cold. Additionally, this drug 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 12 years of age 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

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

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, 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 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.

NSAIDs, with the exception of aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The risk is amplified when the medication is used in excess of the recommended dosage or for an extended period. This medication should not be used in individuals who have previously experienced an allergic reaction to any pain reliever or fever reducer, nor should it be administered immediately before or after heart surgery.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond 10 days; fever worsens or lasts more than 3 days; redness or swelling is observed in the affected area; new symptoms arise; or if any signs of stomach bleeding manifest, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, patients should seek medical attention if they exhibit symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, including severe allergic reactions, gastrointestinal bleeding, and cardiovascular events.

Severe allergic reactions may occur, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, and blisters. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

The use of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of stomach bleeding, which is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use. Patients should be vigilant for signs of gastrointestinal bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use the medication in excess of the recommended dosage or for extended periods. Patients with a history of allergic reactions to other pain relievers or fever reducers, as well as those undergoing heart surgery, should avoid using ibuprofen.

Patients are advised to discontinue use and consult a healthcare provider if pain worsens or persists beyond 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs in the affected area, if new symptoms arise, or if any signs of gastrointestinal bleeding or cardiovascular issues are experienced. Symptoms indicating potential heart problems or stroke include chest pain, difficulty breathing, unilateral weakness, slurred speech, and leg swelling.

Drug Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are administered concurrently for the prevention of heart attack or stroke. It is advisable to monitor patients closely for any signs of reduced efficacy of aspirin in such scenarios. Consideration should be given to the timing of administration, as taking ibuprofen at least 30 minutes after or 8 hours before aspirin may help mitigate this interaction.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen (ibuprofen 200mg). 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 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 crucial not to exceed 6 tablets in a 24-hour period unless directed by a healthcare provider. The smallest effective dose should always be utilized to minimize potential risks.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution when prescribing to this population.

Before initiating treatment, it is advisable for healthcare providers to inquire about any history of adverse reactions to pain relievers or fever reducers in elderly patients. Additionally, a thorough assessment of any pre-existing conditions is crucial, especially for those with a history of stomach problems, such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or prior strokes. This is particularly important for patients aged 60 and older, as their risk profile may necessitate closer monitoring and potential dose adjustments.

In summary, careful consideration and monitoring are recommended when prescribing this medication to geriatric patients, given their heightened vulnerability to serious side effects.

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. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless specifically directed by a doctor, 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 while breastfeeding.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have 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 may be warranted in this population to ensure appropriate management and to mitigate potential risks associated with the use of the medication.

Overdosage

Overdosage of ibuprofen can lead to serious adverse effects that require prompt medical intervention. Healthcare professionals should be aware of the potential symptoms and management strategies associated with ibuprofen overdosage.

Symptoms of Overdose Patients experiencing an overdose may present with a range of symptoms, including nausea, vomiting, headache, dizziness, and drowsiness. In more severe cases, the clinical picture may escalate to include gastrointestinal bleeding, renal failure, and respiratory depression.

Recommended Actions In the event of an overdose, it is imperative to seek emergency medical attention immediately. Timely intervention is crucial to mitigate the risks associated with severe adverse effects. Healthcare providers should be prepared to assess the patient's condition and initiate appropriate management procedures based on the severity of the symptoms presented.

Overall, vigilance in recognizing the signs of ibuprofen overdosage and acting swiftly can significantly impact patient outcomes.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically 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 current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of ibuprofen. Reports have included gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Additionally, cases of cardiovascular events, including myocardial infarction and stroke, have been reported. Some patients have experienced allergic reactions, which include anaphylaxis and angioedema. Furthermore, instances of elevated blood pressure have been noted in patients taking ibuprofen, along with exacerbations of asthma in individuals with a history of the condition.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with overdose. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its effectiveness. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to prevent potential safety risks.

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.

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.