Ibuprofen

Description

Meijer® ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) classified as a pain reliever and fever reducer. Each tablet contains 200 mg of the active ingredient ibuprofen. The dosage form is tablets USP, and the product is packaged in a bottle containing 100 tablets.

The product is distributed by Meijer Distribution, Inc., located in Grand Rapids, MI 49544. It features a tamper-evident safety seal, and users are advised not to use the product if the seal under the cap is broken or missing. This formulation is comparable to the active ingredient found in Motrin® IB. It is important to note that this product is not manufactured or distributed by Kenvue Inc., the owner of the registered trademark Motrin® IB. For more information, visit www.meijer.com.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscular aches, backache, toothache, menstrual cramps, headache, the common cold, and minor pain of arthritis. Additionally, it 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 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a maximum of 2 tablets may be taken. However, the total dosage must 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 advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any 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 facial swelling, blisters, hives, shock, skin reddening, asthma (wheezing), 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 is associated with a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened under certain conditions, including prolonged use beyond the recommended duration, concurrent use of anticoagulants or steroid medications, being aged 60 years or older, taking other NSAIDs (whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen), having a history of stomach ulcers or bleeding disorders, or consuming three or more alcoholic beverages daily while using this product.

Furthermore, NSAIDs, excluding aspirin, are linked to 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.

Healthcare professionals should advise patients to discontinue use and consult a physician if they experience any signs of stomach bleeding, which may manifest as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, patients should seek medical attention if they exhibit symptoms suggestive of heart problems or stroke, including chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body. Other concerning signs include worsening pain lasting more than 10 days, a fever that worsens or persists beyond 3 days, redness or swelling in the affected area, or the emergence of any new symptoms.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

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

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

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 take higher doses or use the medication for extended periods, those who are concurrently using blood thinners or steroid medications, individuals aged 60 or older, and patients with a history of stomach ulcers or bleeding problems. Additionally, consuming three or more alcoholic drinks daily while using ibuprofen may further increase this risk.

Patients should be aware that NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in those who exceed the recommended dosage or duration of use.

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. Furthermore, 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, patients should seek medical advice.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach issues, such as heartburn, or if they are taking diuretics, have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important for patients to inform their healthcare provider if they are under treatment for any serious condition or if they are taking aspirin for heart attack or stroke prevention, 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. It is advisable to monitor patients closely when these medications are used together, as the expected cardioprotective effects of aspirin may be compromised.

Additionally, the use of ibuprofen in conjunction with anticoagulants or steroid medications poses a significant risk of severe gastrointestinal bleeding. Clinicians should exercise caution and consider appropriate dosage adjustments or enhanced monitoring for patients receiving these combinations to mitigate the risk of adverse effects.

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 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. It is important not to exceed 6 tablets in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients may have an increased risk of severe stomach bleeding, particularly those aged 60 years and older. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal bleeding, especially when prescribing medications that may exacerbate this risk.

Additionally, the risk of heart attack, heart failure, and stroke is elevated in geriatric patients who use the medication in excess of the recommended dosage or for an extended duration. Therefore, careful consideration of dosage and treatment duration is crucial in this population to mitigate these potential cardiovascular risks. Regular assessment and monitoring of elderly patients are advised to ensure their safety while on treatment.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is crucial 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 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 while breastfeeding. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically directed by a healthcare provider, 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 discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be warranted in this population to ensure appropriate management and to mitigate potential risks associated with the use of the medication.

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 for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose situation, ensuring the safety and well-being of the patient.

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 non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

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 crucial to inform patients that they should not use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product immediately before or after undergoing heart surgery.

Patients must be instructed to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. They should also be made aware of the symptoms indicative of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, and advised to stop use and seek medical attention if these occur.

Healthcare providers should emphasize that patients need to stop using the medication and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. It is important for healthcare providers to encourage patients to consult a doctor before use if the warning regarding stomach bleeding applies to them, or if they have a history of stomach problems such as heartburn.

Patients should also be advised to seek medical advice before using this medication if they are taking a diuretic, have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or have had a stroke. Furthermore, they should be encouraged to discuss any previous serious side effects from pain relievers or fever reducers with their healthcare provider.

Lastly, patients should be reminded to consult a doctor or pharmacist before use if they are under medical care for any serious condition, if they are taking aspirin for heart attack or stroke (as ibuprofen may reduce the effectiveness of aspirin), or if they are taking any other medications.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a controlled temperature between 20ºC and 25ºC (68ºF to 77ºF). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF).

For proper inventory management, users are advised to check the end flap of the packaging for the expiration date and lot number, ensuring that the product is used within its designated shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly critical 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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)