Ibuprofen

Description

Ibuprofen Tablets USP contain 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each bottle contains 50 film-coated caplets. The product features a tamper-evident seal; it should not be used if the safety seal under the cap is broken or missing.

Uses and Indications

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

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.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is required.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, 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. 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, concurrent use of blood thinners (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 issues, or consuming three or more alcoholic beverages daily while using this product.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, elevate the risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened with excessive or prolonged use.

Before prescribing or recommending ibuprofen, it is advisable to consult a physician if the patient has a history of gastrointestinal issues, such as heartburn, is on diuretics, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, if the stomach bleeding warning is applicable, or if the patient has experienced significant side effects from pain relievers or fever reducers, medical advice should be sought.

Patients should also be advised to consult a doctor or pharmacist prior to use if they are under medical care for any serious condition, are taking aspirin for cardiovascular protection (as ibuprofen may diminish the efficacy of aspirin), or are using any other medications.

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

Patients must be instructed to discontinue use and contact their healthcare provider 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, leg swelling, slurred speech, 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 skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives.

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 take higher doses or use the medication for extended periods, those who are concurrently using blood thinners or steroid medications, individuals aged 60 years or older, and patients with a history of stomach ulcers or bleeding problems. Additionally, the risk increases for those consuming three or more alcoholic drinks daily while using this product.

Patients should be aware that 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 individuals who exceed the recommended dosage or duration of use.

Participants in clinical trials and postmarketing experiences have indicated that patients should discontinue use and consult a healthcare provider if they experience 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, difficulty breathing, leg swelling, slurred speech, or weakness on one side of the body, 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.

Before using ibuprofen, patients with a history of stomach issues, such as heartburn, or those taking diuretics, should consult a healthcare provider. This is also advised for individuals with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke, as well as those who have experienced serious side effects from pain relievers or fever reducers.

Patients under a doctor's care for any serious condition or those taking aspirin for heart attack or stroke should also seek medical advice prior to using ibuprofen, as it may diminish the cardioprotective effects of aspirin. Additionally, consultation with a healthcare professional is recommended for patients taking any other medications.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable to avoid concurrent use of ibuprofen with aspirin in patients who are taking aspirin for these indications.

Additionally, the concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of severe gastrointestinal bleeding. Close monitoring for signs of gastrointestinal bleeding is recommended in patients receiving this combination of therapies. Adjustments to the dosage of ibuprofen or the anticoagulant/steroid may be necessary based on the clinical scenario and patient response.

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 while symptoms persist. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets 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. 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 heightened in geriatric patients who use the medication in excess of the recommended dosage or for an extended duration. Therefore, careful adherence to dosing guidelines is crucial in this population to mitigate these serious cardiovascular risks. Regular assessment and monitoring of elderly patients are advised to ensure their safety while using this medication.

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 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 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 renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 patients with hepatic impairment to ensure appropriate management and to mitigate potential risks associated with the use of this 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 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. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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 documented gastrointestinal bleeding, renal failure, and liver dysfunction. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been reported.

Additionally, there have been cases of cardiovascular events, such as myocardial infarction and stroke. Hypersensitivity reactions, including anaphylaxis and angioedema, have been noted. Instances of elevated liver enzymes and jaundice in patients taking ibuprofen have been observed. Furthermore, postmarketing surveillance has indicated an increased risk of gastrointestinal complications in patients with a history of peptic ulcer disease.

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. Additionally, it should not be used right before or after heart surgery.

Patients must be instructed to stop use and consult a doctor if they experience 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. They should also be advised to stop use and seek medical attention if they exhibit symptoms of heart problems or stroke, such as chest pain, difficulty breathing, leg swelling, slurred speech, or weakness on one side of the body.

Patients should be counseled to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. It is important for patients to consult a doctor before use if they have a history of stomach problems, such as heartburn, or if they are taking a diuretic.

Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also be encouraged to seek medical advice before using this medication. Furthermore, patients should be informed to consult a doctor if the warning regarding stomach bleeding applies to them or if they have experienced problems or serious side effects from taking pain relievers or fever reducers in the past.

Patients under a doctor's care for any serious condition should be advised to consult a doctor or pharmacist before use. Additionally, those taking aspirin for heart attack or stroke should be informed that ibuprofen may reduce the effectiveness of aspirin and should seek advice before using this medication. Lastly, patients should be encouraged to consult a doctor or pharmacist if they are taking any other medications.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which can be referenced for identification. It is essential to store the product at a controlled temperature range of 20º-25ºC (68º-77ºF). 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 critical 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)