Ibuprofen

Description

KIRKLAND Signature Ibuprofen Tablets USP contain ibuprofen as the active ingredient, with a strength of 200 mg per tablet. This dosage form is designed as capsule-shaped tablets, intended for use as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). Each package contains 500 caplets. The product is manufactured by LNK INTERNATIONAL, INC., located at 60 Arkay Drive, Hauppauge, NY 11788, USA, and is distributed by Costco Wholesale Corporation, P.O. Box 34535, Seattle, WA 98124-1535, USA. The product is made in the USA and is identified by the National Drug Code (NDC) 63981-393-14. It is important to note that the product is tamper evident; do not use if the imprinted safety seal under the cap is broken or missing. KIRKLAND Signature Ibuprofen Tablets USP can be compared to MOTRIN® IB, which contains the same active ingredient.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, menstrual cramps, backache, the common cold, toothache, muscular aches, and minor pain of arthritis. Additionally, this drug 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 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, a maximum of 2 caplets may be administered. However, the total daily dosage must 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 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 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, blisters, skin reddening, and rash. 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 carries a risk of severe stomach bleeding. The likelihood of experiencing this adverse effect is heightened under certain conditions, including prolonged use beyond the recommended duration, age 60 or older, a history of stomach ulcers or bleeding disorders, concurrent use of other NSAIDs (such as aspirin, ibuprofen, or naproxen), use of anticoagulants or steroid medications, and consumption of three or more alcoholic beverages daily while using this product.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The risk escalates with the use of higher doses or extended duration beyond the recommended guidelines.

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.

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, bloody or black stools, vomiting blood, or persistent stomach pain. Furthermore, symptoms suggestive of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, 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 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, blisters, skin reddening, and rash.

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. Additional risk factors include being aged 60 or older, having a history of stomach ulcers or bleeding problems, concurrent use of other NSAIDs (including aspirin, ibuprofen, or naproxen), taking anticoagulants or steroid medications, and consuming three or more alcoholic drinks daily while using this product.

Furthermore, the use of NSAIDs, excluding aspirin, has been linked to an elevated 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 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, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, also warrant immediate medical attention. Additionally, patients should 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 painful area, or if any new symptoms arise.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach problems, such as heartburn, 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 important to inform the healthcare provider if the patient is taking a diuretic or has experienced serious side effects from pain relievers or fever reducers.

Patients should seek guidance from a doctor or pharmacist if they are taking any other medications, particularly if they are using aspirin for heart attack or stroke prevention, as ibuprofen may diminish the cardioprotective effects of aspirin. Additionally, those under a doctor's care for any serious condition should consult their healthcare provider prior to use.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, concurrent use of ibuprofen and aspirin is not recommended in patients requiring aspirin for cardiovascular protection.

The concomitant use of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter medications such as aspirin and naproxen, is associated with an increased risk of gastrointestinal bleeding. Caution is advised when prescribing ibuprofen to patients who are already taking other NSAIDs.

Additionally, the use of ibuprofen alongside anticoagulants or steroid medications heightens the risk of gastrointestinal bleeding. Monitoring for signs of bleeding is recommended in patients receiving this combination.

Furthermore, the intake of ibuprofen in conjunction with alcohol, particularly in individuals consuming three or more alcoholic beverages daily, may further elevate the risk of gastrointestinal bleeding. Patients should be advised to limit alcohol consumption while taking ibuprofen to mitigate this risk.

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 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, a dose of 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, are at an increased risk of severe stomach bleeding when using this medication. Therefore, special precautions should be implemented for this population.

Healthcare providers are advised to closely monitor geriatric patients for signs of gastrointestinal complications and other side effects associated with nonsteroidal anti-inflammatory drug (NSAID) use. It is essential to consider these risks when prescribing this medication to elderly patients, and appropriate dose modifications or alternative therapies should be evaluated to ensure patient safety.

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 after 20 weeks of gestation 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 consider the potential benefits and risks when prescribing this medication to 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 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 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 disclose any existing conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke to ensure safe and effective use of the medication. Monitoring of liver function may be warranted in this population to assess any potential impact on drug metabolism and overall safety. Adjustments to dosage or treatment regimens may be necessary based on the severity of hepatic impairment and the patient's overall health status.

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 vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

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 associated with the use of ibuprofen. Reports have included gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented.

Additionally, cardiovascular events, including heart attack and stroke, have been reported. Instances of allergic reactions, such as anaphylaxis and angioedema, have been noted. Furthermore, elevated blood pressure has been observed in some patients taking ibuprofen. Postmarketing surveillance has also recorded occurrences of dizziness and headache among users.

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, or if they are subject to stomach bleeding warnings. Additionally, it is important for patients to discuss their medical history with their healthcare provider, particularly if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they have previously experienced a stroke.

Patients should also be informed to consult their healthcare provider before use if they are taking a diuretic or if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Furthermore, it is essential for patients to speak with their doctor or pharmacist before using this medication if they are currently taking any other drugs.

Lastly, patients should be advised to consult their healthcare provider or pharmacist if they are taking aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin in this context. It is also prudent for patients under a doctor's care for any serious condition to seek guidance before using this medication.

Storage and Handling

The product is supplied with an expiration date clearly indicated on the package. It should be stored at a temperature range of 20º to 25ºC (68º to 77ºF). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

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)