Good Neighbor Pharmacy Ibuprofen

Description

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) available in tablet form, each containing 200 mg of ibuprofen. This formulation serves as a pain reliever and fever reducer. The product is packaged in a bottle containing 250 tablets, with each tablet designed for oral administration.

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 for appropriate dosing guidance.

Contraindications

Use of this product 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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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 an increased risk of severe stomach bleeding. The likelihood of experiencing this adverse effect is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, are taking other NSAIDs (including aspirin, ibuprofen, naproxen, or others), 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 elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in individuals who use the medication 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 at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult a physician 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, they should seek medical advice if they exhibit symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. Other reasons to stop use and consult a healthcare provider include worsening pain lasting more than 10 days, a fever that worsens or persists beyond three days, the presence of redness or swelling in the affected area, or the emergence of any new symptoms.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in seriousness and frequency.

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 significant 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, 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 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 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 experienced 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

Ibuprofen is associated with several significant drug interactions that warrant careful consideration.

Allergic Reactions Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. It is crucial for patients with such allergies to avoid ibuprofen to prevent potential adverse effects.

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. Patients taking these medications should be closely monitored for signs of bleeding and may require dosage adjustments or alternative therapies.

Aspirin Interaction Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, it is advisable for patients to consult their healthcare provider regarding the use of ibuprofen in conjunction with aspirin.

Use of Other NSAIDs The concurrent administration of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and naproxen, is not recommended. This combination may increase the risk of adverse effects without providing additional therapeutic benefit.

Diuretics and Pre-existing Conditions Patients on diuretics should seek medical advice before using ibuprofen, as it may affect renal function. Additionally, individuals with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should consult a healthcare professional prior to ibuprofen use to evaluate potential risks and necessary monitoring.

Packaging & NDC

Below are the non-prescription pack sizes of Good Neighbor Pharmacy 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, a dose of 2 tablets may be administered. However, the total daily 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 the Poison Control Center should be contacted at 1-800-222-1222.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates special precautions for this demographic, especially for individuals with a history of stomach ulcers or bleeding problems.

Additionally, careful consideration should be given to elderly patients who are concurrently taking blood-thinning (anticoagulant) medications or steroid drugs, as these factors may further elevate the risk of gastrointestinal complications. It is essential for healthcare providers to monitor these patients closely and consider appropriate dose modifications or alternative therapies when necessary to ensure their safety.

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 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. 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 may require careful consideration regarding dosing adjustments and monitoring. It is essential to assess renal function prior to initiating treatment, particularly in those with a history of kidney disease. Healthcare professionals should be vigilant in monitoring patients with reduced kidney function, as they may be at increased risk for adverse effects. Special precautions should be taken for patients with comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may further complicate the management of their renal status. Regular evaluation of renal function is recommended to ensure safe and effective use of the medication in this population.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment. For patients with moderate to severe hepatic impairment, dosage adjustments may be necessary to avoid potential toxicity.

Monitoring of liver function tests is recommended throughout the treatment period to ensure safety and efficacy. Special caution should be exercised in patients with liver cirrhosis, as they may be at increased risk for adverse effects.

Additionally, patients with a history of liver disease, including cirrhosis, should be closely monitored for any signs of worsening liver function or complications related to their condition. It is advised that healthcare providers evaluate the overall health status of these patients, including any coexisting conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, which may further complicate treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Reports of serious adverse reactions have been received, including anaphylaxis, angioedema, and various skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Additionally, cases of gastrointestinal bleeding, hepatic injury, renal injury, and cardiovascular events, including myocardial infarction and stroke, have been documented.

Further adverse reactions reported in the postmarketing experience include dizziness, headache, nausea, vomiting, diarrhea, constipation, rash, pruritus, and urticaria. It is important to note that these reactions may not be directly related to the use of ibuprofen but have been identified during postmarketing surveillance.

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 their medical history with their healthcare provider, particularly if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them.

Healthcare providers should also inquire about the patient's medical conditions, including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke, as these may influence the safety of the medication. Patients taking diuretics should 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 reduce the effectiveness of aspirin in this context. It is also prudent for patients to consult their healthcare provider or pharmacist if they are under care for any serious condition or if they are taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product 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 crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients are advised to take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used; however, the total dosage should not exceed 6 tablets in a 24-hour period unless directed by a healthcare professional.

Clinicians should counsel patients who are pregnant or breastfeeding to consult a health professional before use. It is particularly important to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should keep the medication out of reach of children and seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

Drug Information (PDF)

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

View product document (PDF)