Equate Ibuprofen

Description

Ibuprofen Tablets are formulated as a nonsteroidal anti-inflammatory drug (NSAID) with a dosage strength of 200 mg per tablet. Each bottle contains 500 coated tablets, designed for effective pain relief and fever reduction.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, minor pain of arthritis, toothache, backache, the common cold, 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, it is recommended to consult a doctor prior to administration.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, the product should not be administered 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 hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. 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 is associated with a risk of severe stomach bleeding. The likelihood of experiencing this adverse effect is heightened in patients who are aged 60 years or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Furthermore, NSAIDs, excluding aspirin, are linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. The risk is amplified when the medication is used in excess of the recommended dosage or for an extended period.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke warrant immediate medical evaluation and include chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. Patients should also 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 affected area, or if any new symptoms arise.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

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

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use.

Additionally, 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 patients who use the medication in excess of the recommended dosage or for prolonged periods.

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 experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, patients should seek medical advice if their pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three 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 serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have a history of stomach issues such as heartburn. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical advice prior to use. Additionally, patients taking diuretics or aspirin for heart attack or stroke should consult a healthcare professional, 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. Therefore, it is advisable to avoid the simultaneous administration of these medications to ensure optimal cardiovascular protection.

Ibuprofen is associated with an increased risk of severe allergic reactions in individuals with a known allergy to aspirin. This potential for cross-reactivity necessitates careful consideration and monitoring in susceptible patients.

The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, is linked to an elevated risk of serious cardiovascular events, such as heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used in excess of recommended dosages or for prolonged periods. It is essential to adhere strictly to dosing guidelines to mitigate these risks.

Patients should avoid the use of ibuprofen in conjunction with other NSAIDs, whether prescription or over-the-counter, including aspirin and naproxen, to prevent cumulative adverse effects.

Caution is warranted when ibuprofen is prescribed to individuals on anticoagulant therapy or corticosteroids, as the combination may heighten the risk of gastrointestinal bleeding and other complications. Additionally, patients taking diuretics should be monitored closely, as ibuprofen may interfere with the diuretic's efficacy and contribute to fluid retention.

Individuals with a history of gastrointestinal issues, such as heartburn, should exercise caution when using ibuprofen due to the potential for exacerbation of these conditions. Furthermore, patients with pre-existing conditions such as hypertension, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke are advised to consult a healthcare professional prior to initiating ibuprofen therapy to ensure safe use.

Packaging & NDC

Below are the non-prescription pack sizes of Equate Ibuprofen (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 and adults 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. However, the total dosage must not exceed 6 tablets within a 24-hour period unless otherwise directed by a healthcare provider.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and women of childbearing potential 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 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 healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless explicitly 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, caution is recommended when considering the use of this medication while breastfeeding.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, it is essential to evaluate renal function prior to initiating therapy. Regular monitoring of renal parameters is recommended to ensure safe and effective use of the medication. Adjustments to the dosing regimen may be necessary based on the severity of renal impairment to mitigate the risk of adverse effects and optimize therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment and to monitor liver function periodically throughout the course of therapy.

In patients with significant liver impairment, particularly those with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. The prescribing physician should consider the severity of liver dysfunction when determining the appropriate dosage and frequency of administration.

Additionally, patients with hepatic impairment may have an increased risk of adverse effects due to altered drug metabolism. Therefore, close monitoring for signs of toxicity and therapeutic efficacy is recommended.

It is advised that healthcare providers evaluate the overall health status of patients, including any comorbid conditions such as high blood pressure, heart disease, kidney disease, asthma, or history of stroke, as these may further complicate the management of patients with compromised liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop as a result of the overdose.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or 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 reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or individuals taking anticoagulant or steroid medications. Furthermore, an increased risk of heart attack and stroke has been observed with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), excluding aspirin, especially when used in excess of the recommended duration or dosage.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 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 this medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Additionally, it is important for patients to discuss any history of stomach issues, such as heartburn, as well as any applicable stomach bleeding warnings.

Healthcare providers should inquire about the patient's medical history, specifically regarding high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or previous strokes, as these conditions may necessitate caution. Patients taking diuretics should also be advised to consult their healthcare provider prior to use.

Furthermore, patients should be informed to speak with their doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin in these situations. It is crucial for patients under a doctor's care for any serious condition to seek guidance before using this medication. Lastly, patients should be encouraged to discuss any other medications they are currently taking with their healthcare provider or pharmacist to avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to high humidity and excessive heat, particularly temperatures exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of one tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to one tablet, two tablets may be taken; however, the total should not exceed six tablets within a 24-hour period unless otherwise directed by a healthcare professional.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding, particularly emphasizing the risks associated with ibuprofen use during the last trimester of pregnancy. It is crucial to keep the medication out of reach of children, and in the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Equate Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)