Kirkland Signature Ibuprofen Ib

Description

KIRKLAND Signature Ibuprofen Tablets USP are formulated as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 200 mg of ibuprofen as the active ingredient. The product is available in a package containing 500 capsule-shaped tablets, designed for ease of swallowing. This formulation is comparable to Motrin® IB, providing effective relief for various types of pain and reducing 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, and discomfort related to the common cold. 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 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does 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 recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, due to the potential for severe hypersensitivity reactions. Additionally, the use of this product is contraindicated immediately before or after heart surgery, as it may pose risks related to surgical recovery and cardiovascular stability.

Warnings and Precautions

Ibuprofen may elicit 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.

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated 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.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is heightened with the use of higher than recommended doses or prolonged use.

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, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

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. Regular monitoring and assessment of these parameters are essential for the safe use of ibuprofen.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, which contains an NSAID. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

Additionally, the use of this NSAID may lead to severe stomach bleeding, with an increased risk in patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. Symptoms indicative of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain.

The risk of cardiovascular events, such as heart attack, heart failure, and stroke, is also heightened with the use of NSAIDs, excluding aspirin. These events can be fatal, particularly if the medication is used in excess or for prolonged periods. Patients should be vigilant for symptoms of heart problems or stroke, which may include chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Common adverse reactions may include gastrointestinal discomfort, and patients are advised to discontinue use and consult a healthcare professional 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.

Patients should seek medical advice prior to using this product if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies, 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 that patients consult a healthcare provider if they are taking aspirin for cardiovascular protection, as ibuprofen may diminish the effectiveness of aspirin in this context.

Drug Interactions

The concomitant use of ibuprofen with aspirin for the prevention of heart attack or stroke may diminish the therapeutic efficacy of aspirin. It is advisable to consult a healthcare professional regarding the use of these medications together.

Ibuprofen has the potential to induce severe allergic reactions in individuals with a known allergy to aspirin. Caution is warranted in such patients to avoid serious adverse effects.

The concomitant administration of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. Monitoring for signs of bleeding is recommended in patients receiving these combinations.

The use of nonsteroidal anti-inflammatory drugs (NSAIDs), excluding aspirin, is associated with an increased risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used in excess of the recommended dosage or for prolonged periods. Patients should be advised to adhere strictly to dosing guidelines.

It is essential for patients to consult their healthcare provider if they are taking any other medications while using ibuprofen to ensure safe and effective use.

Packaging & NDC

Below are the non-prescription pack sizes of Kirkland Signature Ibuprofen Ib (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, particularly those aged 60 and older, may have an increased risk of stomach bleeding when using this medication. Therefore, it is essential to exercise caution and monitor for any signs of gastrointestinal bleeding in this population.

Additionally, the risk of heart attack and stroke is heightened in elderly patients who use the medication in excess of the recommended dosage or for prolonged periods. It is crucial for healthcare providers to ensure that geriatric patients adhere to the prescribed dosage and duration of treatment.

To minimize potential adverse effects, the smallest effective dose should be utilized in elderly patients. Regular assessment and monitoring are recommended to ensure safety and efficacy in this demographic.

Pregnancy

Pregnant patients and women of childbearing potential should consult a healthcare professional before using this medication. The use of ibuprofen is particularly cautioned against after 20 weeks of gestation unless explicitly directed by a physician. Administration during this period may pose risks to the developing fetus and could lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for pregnant patients considering the use of this medication.

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 available 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 during lactation.

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 parameters 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. Close monitoring of liver function tests is recommended to ensure safety and efficacy.

Additionally, patients with a history of liver disease, including cirrhosis, should be evaluated for potential contraindications and the need for alternative therapeutic options. Regular assessment of blood pressure and cardiovascular status is also advised, particularly in patients with concurrent conditions such as heart disease or kidney disease.

Overall, careful consideration and monitoring are crucial for patients with hepatic impairment to optimize treatment outcomes while minimizing risks.

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 should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations effectively. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may 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 mitigate any adverse effects associated with the overdose.

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 the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and are included for informational purposes.

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 with a doctor prior to use if they have experienced problems or serious side effects from pain relievers or fever reducers. 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 before using this medication. Furthermore, it is important for patients to discuss their use of diuretics with their healthcare provider prior to use.

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

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. 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 should be informed that the medication is administered orally, with a recommended dosage of one caplet every 4 to 6 hours as needed for symptom relief. If symptoms persist and one caplet is insufficient, two caplets may be taken. However, the total daily intake should not exceed six caplets unless directed by a healthcare professional.

Clinicians should counsel patients who are pregnant or breastfeeding to consult a health professional prior to use, particularly emphasizing the risks associated with ibuprofen use after 20 weeks 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 Kirkland Signature Ibuprofen Ib, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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