Ibuprofen

Description

Ibuprofen Tablets USP contain 200 mg of ibuprofen as the active ingredient. This formulation is designed to provide therapeutic effects comparable to those of Advil® Tablets. It is important to note that this product is not manufactured or distributed by the owner of the registered trademark Advil® Tablets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, toothache, muscular aches, backache, menstrual cramps, and minor pain of arthritis. 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 is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, administration is contraindicated 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 such reactions 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 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.

Furthermore, NSAIDs, excluding aspirin, are linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with the use of higher doses or prolonged treatment.

Healthcare professionals should advise patients to discontinue use and consult a physician if they experience any signs of stomach bleeding, 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 of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. Patients should also be instructed to contact their healthcare provider 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.

In cases of overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this serious adverse reaction 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.

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 beyond the directed dosage or duration.

Common adverse reactions may include gastrointestinal symptoms, and patients are advised to discontinue use and consult a healthcare provider if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention.

Patients should seek medical advice before using this product 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 consult a healthcare professional if they are under treatment for any serious condition, are taking aspirin for cardiovascular protection, or are using any other medications.

In clinical trials and postmarketing experiences, the occurrence of these adverse reactions has been documented, emphasizing the importance of monitoring and reporting any new symptoms that may arise during treatment.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable to avoid concurrent use of ibuprofen with aspirin in patients who are taking aspirin for cardiovascular protection. Monitoring for efficacy of aspirin therapy is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Monitoring for gastrointestinal complications is advised, and dosage adjustments should be considered based on the individual patient's health status and concurrent medications. Careful assessment of the benefits and risks is crucial when treating geriatric patients to ensure their safety and well-being.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is crucial to avoid the use of ibuprofen after 20 weeks of gestation 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. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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. Healthcare professionals should be aware of the potential symptoms and management strategies associated with such incidents.

Symptoms of Overdose Patients experiencing an ibuprofen overdose may present with a range of symptoms, including nausea, vomiting, stomach pain, drowsiness, headache, and confusion. In more severe cases, the overdose can lead to critical complications such as kidney failure, liver damage, or 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 potential for serious harm and to initiate appropriate management procedures. Healthcare providers should be prepared to assess the patient's condition and implement necessary treatments based on the severity of the symptoms and the extent of the overdose.

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 indicated that ibuprofen may lead to severe allergic reactions, particularly in individuals with a known allergy to aspirin. Reported symptoms of such reactions include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

Additionally, there is a recognized risk of severe stomach bleeding associated with ibuprofen use, especially in patients aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, individuals taking blood thinners or steroids, those consuming three or more alcoholic drinks daily, or patients using other nonsteroidal anti-inflammatory drugs (NSAIDs). Adverse reactions related to stomach bleeding have been documented, with symptoms such as feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain.

Furthermore, the use of NSAIDs, including ibuprofen, has been linked to an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when ibuprofen is used at higher doses or for prolonged periods. Reports of cardiovascular symptoms have included chest pain, difficulty breathing, unilateral weakness, slurred speech, leg swelling, and exacerbation of pain or fever.

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 to take the medication with food or milk if they experience stomach upset.

Patients must be instructed to discontinue use and consult a doctor if they notice 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 experience 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.

Patients should be counseled to monitor their pain; if it worsens or persists for more than 10 days, or if a fever worsens or lasts more than 3 days, they should contact their healthcare provider. They should also report any redness or swelling in the painful area or the appearance of any new symptoms.

It is important for healthcare providers to remind patients to consult a doctor before use if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Patients should also be advised to seek medical guidance if the warning regarding stomach bleeding applies to them, or if they have a history of stomach issues, such as heartburn.

Furthermore, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should be encouraged to consult a doctor before using the medication. Those taking diuretics or under a doctor’s care for any serious condition should also seek advice prior to use. Lastly, patients should be informed to consult a doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin, or if they are taking any other medications.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20°-25°C (68°-77°F) to maintain its integrity. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F).

Additionally, the product should not be used if the printed seal under the cap is missing or damaged, as this may compromise its safety and efficacy. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not respond to 1 tablet, 2 tablets may be taken; however, the total should not exceed 6 tablets in a 24-hour period unless directed by a healthcare professional. For children under 12 years, consultation with a doctor is advised before use.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding. It is particularly important to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a healthcare provider, 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)