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 tablets. The product is tamper evident; do not use if the imprinted safety seal under the cap is broken or missing. This formulation is not manufactured or distributed by PF Consumer Healthcare 1 LLC, the owner of the registered trademark Advil® Tablets. The product is distributed by 7-Eleven, Inc., located in Irving, TX 75063. For more information, visit www.7-eleven.com or contact customer service at 1-800-255-0711.

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, 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 daily 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 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 is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

Allergy Alert Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include shock, skin reddening, asthma (wheezing), rash, facial swelling, hives, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek 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 increases under certain conditions, including but not limited to: prolonged use beyond the recommended duration, concurrent use with anticoagulants or steroid medications, being aged 60 years or older, taking other NSAIDs (either prescription or over-the-counter), having a history of stomach ulcers or bleeding disorders, or consuming three or more alcoholic beverages daily while using this product.

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly heightened when ibuprofen is used in excess of the recommended dosage or for an extended period.

General Precautions Healthcare providers should advise patients to consult a physician prior to using ibuprofen if they have a history of gastrointestinal issues, such as heartburn, or if they are currently taking diuretics. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical advice before use. Additionally, individuals who have experienced adverse effects from pain relievers or fever reducers should be cautioned. It is also advisable to consult a doctor or pharmacist if the patient is under treatment for any serious condition, is taking aspirin for cardiovascular protection (as ibuprofen may diminish the efficacy of aspirin), or is using any other medications.

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

Signs to Discontinue Use and Contact a Doctor Patients should be instructed to stop taking ibuprofen and seek medical advice if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, passing 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 contact their healthcare provider 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 shock, skin reddening, asthma (wheezing), rash, facial swelling, hives, and blisters.

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. This risk is further elevated in individuals who are taking anticoagulants or steroid medications, are aged 60 years or older, have a history of stomach ulcers or bleeding problems, or consume three or more alcoholic drinks daily while using the product. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, has been linked to an increased 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 symptoms indicative of stomach bleeding or heart problems, such as chest pain, trouble breathing, leg swelling, slurred speech, or weakness on one side of the body. Other concerning signs include worsening pain lasting more than 10 days, fever persisting for more than 3 days, redness or swelling in the painful area, or the emergence of any new symptoms.

Before using ibuprofen, patients should seek medical advice if they have a history of stomach issues, are taking diuretics, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important for patients to inform their healthcare provider if they are under treatment for any serious condition or if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

The concomitant use of ibuprofen with aspirin, particularly in the context of cardiovascular events such as heart attack or stroke, may diminish the therapeutic efficacy of aspirin. This interaction is primarily pharmacodynamic in nature, as both medications can affect platelet aggregation, potentially leading to reduced cardiovascular protection.

Patients with a known allergy to aspirin should exercise caution when using ibuprofen, as it may precipitate severe allergic reactions. This highlights the importance of thorough patient history assessment prior to initiating ibuprofen therapy.

The risk of gastrointestinal bleeding is significantly increased when ibuprofen is used in conjunction with anticoagulants or steroid medications. This pharmacokinetic interaction necessitates careful monitoring of patients who are prescribed these combinations, and dosage adjustments may be warranted based on individual risk factors.

It is advisable for patients to consult a healthcare professional before starting ibuprofen if they are currently taking any other medications. This precaution ensures that potential drug interactions are adequately evaluated and managed.

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 for symptom relief. 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. 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 extended periods. Therefore, careful consideration of dosage and duration of therapy 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 should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is crucial to avoid the use of ibuprofen after 20 weeks of gestation unless explicitly directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should weigh the potential benefits against the 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 this medication 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 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 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 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 current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including cases of anaphylaxis, angioedema, and various skin reactions such as rash, pruritus, and urticaria. Gastrointestinal adverse events have also been reported, encompassing gastrointestinal bleeding, ulceration, and perforation.

Cardiovascular events, including heart attack and stroke, have been documented. Additionally, renal adverse events such as acute renal failure and interstitial nephritis have been observed. Hepatic adverse events, including elevations in liver enzymes and instances of hepatitis, have been reported as well.

Hematologic adverse events, including thrombocytopenia and aplastic anemia, have been noted. Lastly, central nervous system adverse events, such as dizziness and headache, have also been identified in the postmarketing experience.

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 encouraged to consult with their healthcare provider before using the medication if they have a history of stomach problems, such as heartburn. Additionally, it is important for patients to discuss their current medications with their healthcare provider, particularly if they are taking a diuretic, as well as to disclose any history of high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or previous strokes.

Healthcare providers should also inform patients to seek medical advice if they have a history of stomach bleeding or if they have experienced problems or serious side effects from taking pain relievers or fever reducers. Patients under a doctor's care for any serious condition should be advised to consult their healthcare provider or pharmacist before using the medication.

Furthermore, patients taking aspirin for the prevention of heart attack or stroke should be cautioned that ibuprofen may diminish the cardioprotective effects of aspirin. Lastly, it is essential for patients 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 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 20° to 25°C (68° to 77°F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). For proper tracking and quality assurance, the expiration date and lot number are located on the end flap of the packaging.

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 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)