Basic Care Ibuprofen

Description

Ibuprofen Tablets are formulated as a nonsteroidal anti-inflammatory drug (NSAID) with a dosage strength of 200 mg per tablet. Each pouch contains two coated tablets, with a total of 50 pouches, resulting in 100 coated tablets per package. These tablets are indicated for the relief of pain and reduction of fever.

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 is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, due to the risk of severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may interfere with postoperative recovery and increase the risk of complications.

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 60 years of age 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.

NSAIDs, with the exception of aspirin, are linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. The risk is particularly elevated in patients who use higher than recommended doses or extend the duration of treatment beyond what is advised.

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

Patients should be advised 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, symptoms suggestive of heart problems or stroke warrant immediate medical evaluation, including 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, 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 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 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 ibuprofen in higher doses or for extended 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 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 conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended to seek advice if taking a diuretic or if under a doctor's care for any serious condition.

Patients taking aspirin for the prevention of heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin and should consult a healthcare professional before use.

Drug Interactions

Patients taking anticoagulants or steroid medications may experience significant drug interactions. The concurrent use of these agents can increase the risk of bleeding or other adverse effects. It is advisable for healthcare providers to closely monitor patients on these medications for any signs of increased bleeding or other complications.

The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription options such as aspirin, ibuprofen, and naproxen, can also lead to interactions. Co-administration of these NSAIDs may heighten the risk of gastrointestinal bleeding and renal impairment. Therefore, it is recommended that healthcare professionals assess the necessity of NSAID therapy in patients already receiving anticoagulants or steroids and consider alternative pain management strategies when appropriate.

Particularly noteworthy is the interaction between aspirin and ibuprofen. When ibuprofen is taken concurrently with aspirin for cardiovascular protection, it may diminish the cardioprotective effects of aspirin. Clinicians should advise patients to avoid the use of ibuprofen if they are taking aspirin for the prevention of heart attacks or strokes, and to consider alternative analgesics that do not interfere with aspirin's efficacy.

No specific laboratory test interactions have been identified in the provided data.

Packaging & NDC

Below are the non-prescription pack sizes of Basic Care 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 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, 2 tablets may be administered. However, the total dosage must not exceed 6 tablets in a 24-hour period unless directed by a healthcare provider. It is essential to keep this medication out of reach of children to prevent accidental ingestion.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to consider this heightened risk when prescribing and monitoring treatment in this population.

Additionally, nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of aspirin, are associated with an elevated risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is further amplified in elderly patients who exceed the recommended dosage or duration of use. Therefore, careful assessment of the benefits and risks, along with appropriate dose adjustments and close monitoring, is crucial when treating geriatric patients with NSAIDs.

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 during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery.

Lactation

Lactating mothers are advised to consult a health 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, healthcare providers should carefully consider the potential risks and benefits when recommending this medication to 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 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 liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects due to impaired drug metabolism. The prescribing physician should consider the severity of hepatic impairment when determining the appropriate dosage.

Additionally, patients with a history of liver disease, including cirrhosis, should be closely monitored for any signs of worsening liver function or potential drug-related hepatotoxicity. Regular assessment of liver enzymes and other relevant laboratory values is recommended to ensure patient safety and therapeutic efficacy.

Patients with significant hepatic impairment should be approached with caution, and alternative therapeutic options may be considered based on the clinical scenario.

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 during the course of treatment.

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 regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

During postmarketing use of ibuprofen, various adverse reactions have been reported voluntarily or through surveillance programs. These include:

Allergic reactions, such as anaphylaxis and serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Cardiovascular events have also been noted, encompassing heart attack and stroke.

Gastrointestinal complications, including bleeding, ulceration, and perforation, have been documented. Additionally, liver injury has been reported, characterized by elevated liver enzymes and hepatitis. Renal injury cases, including acute renal failure and interstitial nephritis, have been observed.

Hematologic reactions, such as thrombocytopenia and aplastic anemia, have been identified. Central nervous system effects, including headache, dizziness, and aseptic meningitis, have also been reported. Respiratory reactions, particularly asthma exacerbation, have been noted, along with other reactions such as tinnitus and visual disturbances.

Patient Counseling

Patients should be advised 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.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Additionally, patients should be informed to ask a doctor before use if they have a history of stomach issues, such as heartburn, or if the stomach bleeding warning applies to them.

Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also be advised to consult a doctor prior to use. Furthermore, it is important for patients to discuss their use of diuretics with their healthcare provider before starting this medication.

Patients taking aspirin for heart attack or stroke should be cautioned to speak with a doctor or pharmacist, as ibuprofen may reduce the effectiveness of aspirin in these situations. Lastly, patients under a doctor’s care for any serious condition or those taking any other medications should be encouraged to consult their healthcare provider or pharmacist before using this medication.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled 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).

Additionally, the integrity of the packaging is crucial; the product should not be used if the printed pouch is found to be torn or punctured. Proper handling and storage conditions are vital to ensure the product's efficacy and safety.

Additional Clinical Information

Patients should take the medication orally, with a recommended dosage of 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be taken. However, the total dosage should not exceed 6 tablets in a 24-hour period unless directed by a healthcare professional.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding, as the use of ibuprofen during the last trimester of pregnancy may pose risks to the unborn child or lead to complications during delivery. Additionally, it is crucial to keep the medication out of reach of children and to 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 Basic Care Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)