Ibuprofen

Description

Ibuprofen Tablets USP are formulated as coated tablets, each containing 200 mg of ibuprofen. This nonsteroidal anti-inflammatory drug (NSAID) serves as a pain reliever and fever reducer. The product is distributed by LIDL US, LLC, located in Arlington, VA 22202. The packaging includes a tamper-evident feature; the product should not be used if the imprinted safety seal under the cap is broken or missing. For inquiries, consumers may contact 1-844-344-5071 or visit www.lidl.com.

Uses and Indications

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

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. In cases where pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. However, 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 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. 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 skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives. 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 heightened under certain conditions, including prolonged use beyond the recommended duration, concurrent use of anticoagulants or steroid medications, being aged 60 years or older, taking other NSAIDs (either prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen), having a history of stomach ulcers or bleeding disorders, or consuming three or more alcoholic beverages daily while using this product.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The risk escalates with dosages exceeding the recommended amount or with prolonged use.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following symptoms arise, as they may indicate stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Patients should also seek medical advice if they exhibit symptoms suggestive of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body. Furthermore, patients should be instructed to consult a healthcare provider if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if any new symptoms develop, or if redness or swelling occurs in the affected area.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients using ibuprofen should be aware of several potential adverse reactions, which can range from serious to common.

Severe allergic reactions may occur, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients who take higher doses or use the medication for extended periods, those who are 60 years of age or older, individuals taking anticoagulants or steroid drugs, and patients with a history of stomach ulcers or bleeding problems. Additionally, consuming three or more alcoholic drinks daily while using ibuprofen may further increase this risk.

Patients should also be informed of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified when the medication is used in excess or for longer than recommended.

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 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. Furthermore, if pain worsens or persists beyond 10 days, or if fever intensifies or lasts more than 3 days, patients should seek medical advice. Any new symptoms or the presence of redness or swelling in the painful area should also prompt consultation with a healthcare provider.

Before using ibuprofen, patients should consult a doctor if they have a history of stomach problems, such as heartburn, or if they are taking diuretics, have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important for patients under a doctor's care for serious conditions or those taking aspirin for heart attack or stroke to seek medical advice, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

The use of ibuprofen is associated with several important drug interactions that may impact patient safety and treatment efficacy.

Pharmacodynamic Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when both medications are taken concurrently for the prevention of heart attack or stroke. Therefore, it is advisable to avoid the simultaneous use of ibuprofen and aspirin in patients requiring aspirin for cardiovascular protection.

Additionally, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. Clinicians should exercise caution and consider alternative pain management strategies in patients who are on these medications.

Pharmacokinetic Interactions

Patients taking diuretics should be monitored closely when using ibuprofen, as it may adversely affect renal function. It is recommended to assess kidney function periodically in these patients and adjust ibuprofen dosage as necessary.

Furthermore, 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. Clinicians should evaluate the necessity of ibuprofen therapy and consider the lowest effective dose for the shortest duration possible in at-risk populations.

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. In cases where pain or fever does not adequately respond to 1 tablet, a dose of 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 may have an increased risk of severe stomach bleeding, particularly those aged 60 years and older. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal bleeding, especially when prescribing medications that may exacerbate this risk.

Additionally, the risk of heart attack, heart failure, and stroke is elevated in geriatric patients who use the medication in excess of the recommended dosage or for an extended duration. Therefore, careful consideration of dosage and treatment duration is crucial in this population to mitigate these potential cardiovascular risks. Regular assessment and monitoring of elderly patients are advised to ensure their safety while on treatment.

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 pregnancy 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 while breastfeeding. 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 provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

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 function and associated health conditions.

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 to ensure appropriate management and to mitigate potential risks associated with the use of this medication in individuals with hepatic impairment.

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 aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. This may include monitoring vital signs, providing respiratory support, and administering activated charcoal if indicated and within the appropriate time frame. In cases where specific antidotes are available, their use should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the safety and well-being of the patient.

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 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, there have been cases of cardiovascular events, including myocardial infarction and stroke. Hypersensitivity reactions, such as anaphylaxis and angioedema, have been reported. Instances of elevated blood pressure have been noted in patients taking ibuprofen, along with reports of dizziness and headache as adverse reactions.

There is a potential risk of serious gastrointestinal events, including ulceration and perforation, particularly in patients with a history of gastrointestinal disease.

Patient Counseling

Patients should be advised 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.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if they are subject to a stomach bleeding warning. Additionally, patients should be advised to discuss their medical history with their healthcare provider, particularly if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they have previously experienced a stroke.

Patients should also be informed to consult a doctor before use if they are taking a diuretic or if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. It is important for patients to communicate with their healthcare provider or pharmacist if they are under medical care for any serious condition.

Furthermore, patients should be cautioned to ask a doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin in this context. Lastly, patients should be encouraged to discuss any other medications they are currently taking with their healthcare provider or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. 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, defined as temperatures exceeding 40°C (104°F). Additionally, it is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

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)