Ibuprofen

Description

Ibuprofen is formulated as IBUPROFEN Tablets USP, each containing 200 mg of the active ingredient. This nonsteroidal anti-inflammatory drug (NSAID) is indicated for use as a pain reliever and fever reducer. The product is packaged in a quantity of 100 coated tablets, which are designed to be of actual size for ease of administration.

The tablets are tamper evident; users are advised not to use the product if the imprinted safety seal under the cap is broken or missing. This formulation is manufactured for Your Military Exchanges and distributed by LNK International, Inc., located in Hauppauge, NY 11788. For customer inquiries, a service line is available at 1-800-426-9391. A satisfaction guarantee is offered, ensuring customer satisfaction or a refund of the purchase price.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including menstrual cramps, toothache, backache, the common cold, headache, 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 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a maximum of 2 tablets may be taken. However, the total dosage must 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 advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer, due to the potential for severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks to surgical outcomes and patient safety.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include facial swelling, shock, asthma (wheezing), skin reddening, hives, blisters, and rash. 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 this adverse effect increases under certain conditions, including prolonged use beyond the recommended duration, age 60 or older, concurrent use of blood thinners (anticoagulants) or steroid medications, use of other NSAIDs (either prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen), a history of stomach ulcers or bleeding issues, and consumption of three or more alcoholic beverages daily while using this product.

Additionally, NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened with excessive or prolonged use.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, previous stomach issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, a history of stroke, concurrent use of diuretics, or previous adverse reactions to pain relievers or fever reducers.

In cases of overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, warrant immediate medical evaluation. Furthermore, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new symptoms arise, patients should seek medical advice promptly.

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 facial swelling, shock, asthma (wheezing), skin reddening, hives, blisters, and rash.

The use of ibuprofen is associated with an increased risk of severe stomach bleeding, particularly in patients who take more than the recommended dose or for an extended duration. Additional risk factors include being aged 60 or older, concurrent use of blood thinners (anticoagulants) or steroid medications, use of other NSAIDs (including aspirin, ibuprofen, or naproxen), a history of stomach ulcers or bleeding problems, and consumption of three or more alcoholic drinks daily while using this product.

Furthermore, NSAIDs, including ibuprofen, have been linked to 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 longer than directed.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, also warrant immediate medical attention. Additionally, 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.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach problems, 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. It is also important to inform the healthcare provider if the patient is taking a diuretic or has experienced serious side effects from pain relievers or fever reducers. Additionally, patients under a doctor's care for any serious condition or those taking aspirin for heart attack or stroke should seek medical advice, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

The concomitant use of ibuprofen with aspirin for the prevention of heart attack or stroke may diminish the therapeutic efficacy of aspirin. Therefore, careful consideration should be given to the timing and dosage of these medications to optimize their benefits.

Patients with a known allergy to aspirin may experience severe allergic reactions when taking ibuprofen. It is advised that individuals with such allergies avoid the use of ibuprofen to prevent potential adverse effects.

The co-administration of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. Monitoring for signs of bleeding is recommended in patients receiving this combination, and dosage adjustments may be necessary based on clinical judgment.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, is associated with an elevated risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used in higher doses or for extended periods. It is advisable to limit the duration and dosage of ibuprofen to mitigate these risks.

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 while symptoms persist. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients may have an increased risk of severe stomach bleeding, particularly those aged 60 years and older. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, as the likelihood of gastrointestinal complications may be heightened in this population.

Additionally, the risk of cardiovascular events, including heart attack, heart failure, and stroke, is elevated in elderly patients who exceed the recommended dosage or duration of treatment. It is essential for healthcare providers to monitor these patients closely and consider appropriate dose adjustments to mitigate these risks. Regular assessment of the patient's overall health status and adherence to prescribed guidelines is advised to ensure safe and effective use of the medication in geriatric populations.

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 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 healthcare 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 physician, 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 during lactation.

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 tests 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to remain alert to any signs of toxicity or adverse reactions that may develop.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. The healthcare provider should ensure that the patient is stabilized and that appropriate measures are taken to address any complications that may arise from 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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

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 heart attack and stroke, have been reported. Instances of allergic reactions, such as anaphylaxis and angioedema, have been noted. Furthermore, elevated blood pressure has been observed in some patients taking ibuprofen. Postmarketing surveillance has indicated an increased risk of gastrointestinal complications in individuals with a history of ulcers or gastrointestinal bleeding.

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 crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset. This guidance can help mitigate gastrointestinal discomfort and enhance the overall tolerability of the treatment.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20º to 25ºC (68º to 77ºF) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF).

For proper inventory management, users are advised to check the end flap of the packaging for the expiration date and lot number, ensuring that the product is used within its designated shelf life.

Additional Clinical Information

The medication is administered orally. 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 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)