Ibuprofen

Description

Distributed by GENUINE FIRST AID, this product is located at 600 Cleveland Str Suite 400, Clearwater, FL 33755.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, minor pain of arthritis, 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 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, this medication is contraindicated and should not be administered.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, the product should not be administered to individuals who have undergone heart surgery, either immediately before or after the procedure, due to potential adverse effects.

Warnings and Precautions

Patients should be informed of the following warnings and precautions associated with the use of ibuprofen.

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

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in patients who meet any of the following criteria: those aged 60 years or older, individuals with a history of stomach ulcers or bleeding disorders, patients concurrently using anticoagulants or steroid medications, those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents), individuals consuming three or more alcoholic beverages daily while using this product, or those who exceed the recommended dosage or duration of use.

Monitoring for Signs of Stomach Bleeding Patients should be advised to discontinue ibuprofen and contact their healthcare provider if they experience any signs of stomach bleeding. These signs include feeling faint, vomiting blood, passing bloody or black stools, experiencing stomach pain that does not improve, having pain that worsens or persists beyond 10 days, or if fever worsens or lasts more than 3 days. Additionally, any redness or swelling in the painful area or the emergence of new symptoms warrants immediate medical consultation.

Emergency Medical Help In the case of an allergic reaction, it is crucial to stop the use of ibuprofen and seek emergency medical help without delay.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, particularly those related to allergic responses and gastrointestinal complications.

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

Additionally, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients who are aged 60 or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (such as aspirin or naproxen), consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients should be instructed to stop using ibuprofen and consult a healthcare professional if they experience any signs indicative of stomach bleeding. These signs include feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, worsening pain lasting more than 10 days, a fever that worsens or persists beyond three days, redness or swelling in the painful area, or the emergence of any new symptoms.

Drug Interactions

Ibuprofen has been shown to potentially diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. This interaction is particularly relevant for patients who are prescribed aspirin for these indications, as the concurrent use of ibuprofen may reduce the efficacy of aspirin therapy.

Additionally, the use of other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter, should be approached with caution. It is recommended that patients discuss the use of any NSAID with their healthcare provider to evaluate the potential for interactions and to ensure optimal therapeutic outcomes.

Healthcare professionals should monitor patients closely when ibuprofen is used in conjunction with aspirin, particularly in those at risk for cardiovascular events. Adjustments to therapy may be necessary based on individual patient circumstances and clinical judgment.

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 not be administered this medication. For adolescents aged 12 years and older, the recommended dosage is 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, 2 tablets may be taken. It is important not to exceed 6 tablets within a 24-hour period unless directed by a healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of stomach bleeding when using this medication. It is essential for healthcare providers to assess the individual risk factors for each geriatric patient prior to prescribing.

Healthcare providers should advise elderly patients to consult with their physician before using this medication if they have a history of stomach problems, such as heartburn, or if they have comorbid conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease. Close monitoring and careful consideration of the patient's overall health status are recommended to mitigate potential risks associated with treatment in this population.

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 this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating individuals.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 lead to significant adverse effects that require prompt medical intervention. Healthcare professionals should be aware of the potential symptoms associated with an overdose, which may include nausea, vomiting, headache, dizziness, and gastrointestinal bleeding.

In the event of an overdose, it is crucial to seek immediate medical attention. Timely intervention can mitigate the risks associated with ibuprofen overdosage and facilitate appropriate management of the symptoms presented.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis and angioedema. Additionally, skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been documented.

Cardiovascular events, including myocardial infarction and stroke, have also been reported in association with the use of ibuprofen. Furthermore, liver enzyme elevations have been observed in some patients during postmarketing surveillance. Notably, cases of aseptic meningitis have been reported, particularly among patients with systemic lupus erythematosus.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer, or if they have undergone heart surgery recently.

It is important for healthcare providers to instruct patients to stop using the medication 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 stomach pain that does not improve. Patients should also be advised to seek medical attention if their pain worsens or lasts more than 10 days, if their fever worsens or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms appear.

Patients should be counseled to take the medication with food or milk if they experience stomach upset while using it.

Healthcare providers should encourage patients to consult a doctor before using this medication if the stomach bleeding warning applies to them, if they have a history of stomach problems such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients should be advised to seek medical advice if they are taking a diuretic.

Finally, patients should be reminded to consult a doctor before using this medication if they are taking any other drug containing NSAIDs, whether prescription or nonprescription, or if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin. They should also inform their healthcare provider about any other medications they are currently taking.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to avoid using any packets that are opened or torn.

For optimal storage, the product should be maintained at a controlled room temperature, ensuring that it does not exceed 40 degrees Celsius (104 degrees Fahrenheit). Care should be taken to avoid exposure to excessive heat, which may compromise the product's quality.

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)