Ibuprofen

Description

The product consists of three distinct tablet formulations, each characterized by specific physical attributes and identification markings.

The first formulation is an orange, round-shaped tablet, debossed with "BI 02," and is available in a quantity of 50,864 tablets. It is identified by the National Drug Code (NDC) number 11788-002-00.

The second formulation is a white, round-shaped tablet, debossed with "BI 04," also available in a quantity of 50,864 tablets, with the NDC number 11788-004-00.

The third formulation is a brown, round-shaped tablet, debossed with "BI 06," similarly available in a quantity of 50,864 tablets, and is identified by the NDC number 11788-006-00.

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 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, due to the risk of severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may interfere with postoperative recovery and increase the risk of complications.

Warnings and Precautions

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of experiencing this adverse effect is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using 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, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods.

Ibuprofen should not be used in individuals with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, nor should it be administered immediately before or after heart surgery.

Healthcare professionals should advise patients to consult a doctor prior to use if they have experienced problems or serious side effects from pain relievers or fever reducers, if the stomach bleeding warning is applicable, if they have a history of gastrointestinal issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, patients taking diuretics should seek medical advice before use.

Patients should also be counseled to consult a doctor or pharmacist before using ibuprofen if they are taking aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin. Those under a physician's care for serious medical conditions or those taking other medications should also seek guidance.

When using ibuprofen, it is recommended to take the medication with food or milk to mitigate potential stomach upset.

Patients should discontinue use and consult a doctor 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, they 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. Patients should also stop use if pain worsens or persists for more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

For pregnant or breastfeeding patients, it is essential to consult a healthcare professional before use. Ibuprofen should be avoided 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.

This medication should be kept out of reach of children. In the event of an overdose, immediate medical attention should be sought, or contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

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.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use. Patients 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, 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 prolonged periods. Patients should discontinue use and consult a healthcare provider if they experience symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Other important considerations include the persistence of pain beyond 10 days, worsening fever lasting more than 3 days, the presence of redness or swelling in the affected area, or the emergence of any new symptoms. In such cases, patients are advised to seek medical attention.

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 shortly before or after aspirin may further impact its protective benefits.

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 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 otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing medications that may contribute to gastrointestinal complications.

Additionally, the warning regarding stomach bleeding is specifically applicable to individuals in this age group. Healthcare providers should monitor elderly patients closely for any signs of gastrointestinal distress and consider alternative therapies when appropriate.

Furthermore, the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in geriatric patients carries an elevated risk of serious cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used beyond the recommended duration or dosage. Therefore, it is essential for healthcare providers to evaluate the necessity of NSAID therapy in elderly patients and to adhere strictly to dosing guidelines to mitigate these risks. Regular assessment and monitoring of cardiovascular health in this population are strongly advised.

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 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 a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be warranted in this population to ensure appropriate management and to mitigate potential risks associated with the use of the medication.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as symptoms may vary depending on the substance involved. It is essential for healthcare providers to assess the patient's condition thoroughly and initiate appropriate management procedures based on the clinical presentation and the specific agent involved in the overdose.

Monitoring and supportive care may be necessary, and healthcare professionals should be prepared to implement standard protocols for overdose management, including the administration of activated charcoal if indicated and the provision of symptomatic treatment as required.

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 healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as anaphylaxis, angioedema, and urticaria. Gastrointestinal complications have been noted, including bleeding, ulceration, and perforation, which may occur unexpectedly at any time during treatment. Renal toxicity has been observed, encompassing acute renal failure and interstitial nephritis. Hepatic toxicity has also been reported, characterized by elevated liver enzymes and hepatitis. Additionally, cardiovascular events, including myocardial infarction and stroke, have been documented. Skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have also been reported.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center or their healthcare provider without delay, and they can reach the Poison Control Center at 1-800-222-1222 for guidance.

Storage and Handling

This product is supplied in bulk shipments intended solely for further processing. It is essential to repackage the contents immediately upon receipt and ensure that all repackaged items are labeled in strict accordance with the Food, Drug, and Cosmetic Act and its associated regulations.

Storage conditions require that the product be maintained at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). Additionally, it is crucial to protect the product from light exposure to maintain its integrity.

To ensure safety, the product must be kept out of reach of children. It is advisable to retain the original box for important information regarding the product.

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.

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)