Ibuprofen

Description

The product is presented in an 80's style carton, as depicted in the accompanying image. The carton serves as the principal display panel for the packaging. The effective date of this labeling is December 28, 2022. The carton is identified by the code 51945-4, which is part of the code system 2.16.840.1.113883.6.1.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothache, backache, menstrual cramps, the common cold, muscular aches, 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

Patients should adhere strictly to the recommended dosage and not exceed the directed amount. The smallest effective dose should be utilized to manage symptoms effectively.

For adults and children aged 12 years and older, the recommended dosage is 1 capsule every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be administered. However, it is imperative that the total dosage does not exceed 6 capsules within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor before administration.

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 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 an extended period.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center or seek emergency medical help 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, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. 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. 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 the potential risk of severe stomach bleeding. This risk is heightened 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.

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 are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing 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. Furthermore, 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 painful area, or if any new symptoms arise.

It is recommended that patients consult a healthcare provider prior to use if any of the following conditions apply: a history of stomach bleeding, serious side effects from pain relievers or fever reducers, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients should also inform their healthcare provider if they are taking diuretics or are under medical care for any serious condition. Additionally, those taking aspirin for heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

The use of ibuprofen in conjunction with other medications requires careful consideration due to potential interactions that may affect clinical outcomes.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Ibuprofen may diminish the cardioprotective effects of aspirin when both are administered for the prevention of heart attack or stroke. It is advisable to monitor patients closely when these medications are used concurrently, particularly in those with a history of cardiovascular events.

The concomitant use of ibuprofen with other NSAIDs, whether prescription or nonprescription (such as aspirin or naproxen), significantly elevates the risk of gastrointestinal bleeding. Clinicians should exercise caution and consider alternative pain management strategies in patients requiring multiple NSAIDs.

Anticoagulants and Corticosteroids Co-administration of ibuprofen with anticoagulants or corticosteroids may further increase the risk of gastrointestinal bleeding. It is recommended that healthcare providers assess the necessity of ibuprofen in patients on these medications and consider appropriate dosage adjustments or enhanced monitoring for signs of bleeding.

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 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important to note that the maximum dosage should not exceed 6 capsules within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years 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 elderly 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 profile is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and women who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of gestation unless specifically directed by a physician. The use of ibuprofen during this period may be associated with potential delivery complications and adverse fetal outcomes. Therefore, healthcare providers should carefully evaluate the risks and benefits before prescribing this medication to pregnant patients, especially in the later stages of pregnancy.

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 lead to delivery complications for the unborn child. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential risks and benefits when considering the use of this medication in lactating mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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. These symptoms can vary in severity depending on the amount ingested and the individual patient's response.

In more severe cases, ibuprofen overdose can lead to critical complications such as kidney failure, liver damage, and gastrointestinal bleeding. These conditions require immediate medical attention and intervention.

Recommended Actions If an ibuprofen overdose is suspected, it is imperative to seek emergency medical help without delay. Prompt evaluation and treatment are essential to mitigate the potential adverse effects and to manage any complications that may arise from the overdose. Healthcare professionals should be prepared to provide supportive care and monitor the patient closely for any signs of severe toxicity.

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 delivery 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 specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified a range of adverse reactions associated with the use of the product. Reports of allergic reactions have included hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

Gastrointestinal adverse events have been noted, including stomach bleeding, which may occur in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood-thinning (anticoagulant) or steroid medications, users of other drugs containing prescription or nonprescription NSAIDs, and those consuming three or more alcoholic drinks daily while using this product. Additionally, gastrointestinal complications such as bleeding, ulceration, and perforation of the stomach or intestines can occur at any time during use and without warning.

Renal adverse events, including acute kidney injury and chronic kidney disease, have also been reported. Furthermore, elevations in liver enzymes and instances of liver injury have been documented in the postmarketing experience.

Serious skin reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported. Cardiovascular events, including myocardial infarction and thrombotic events, have been observed in the postmarketing data, particularly with higher doses or prolonged use. An increased risk of heart attack, heart failure, and stroke has also been noted, especially in patients using higher doses or for extended periods.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is recommended that patients take the medication with food or milk if they experience stomach upset.

Patients should be instructed to discontinue use and consult a doctor if they notice any signs of stomach bleeding, which may 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 informed that if their pain worsens or persists for more than 10 days, or if their 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.

Before initiating treatment, patients should be encouraged to consult a doctor if any of the following apply: they have a history of stomach bleeding, have experienced serious side effects from pain relievers or fever reducers, have a history of stomach problems such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients taking diuretics should also seek medical advice prior to use.

Furthermore, patients should be advised to consult a doctor or pharmacist before using the medication if they are under medical care for any serious condition, are taking aspirin for heart attack or stroke (as ibuprofen may reduce the effectiveness of aspirin), or are taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures above 40°C (104°F). Additionally, the product must be protected from light to maintain its integrity and efficacy.

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 after 20 weeks of pregnancy unless specifically directed by a physician, as it may lead to delivery complications for the unborn child or 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)