Uline Ibuprofen

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, toothache, backache, menstrual cramps, common cold, muscular aches, and minor arthritis pain. 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 any other pain reliever or fever reducer. Additionally, it should not be administered immediately before or after heart surgery due to potential complications.

Patients should discontinue use and consult a healthcare professional if they experience 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, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new or unexpected symptoms arise, medical advice should be sought.

Warnings and Precautions

Ibuprofen is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

Allergy Alert Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction can include hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. This risk is heightened in patients who meet any of the following criteria: those aged 60 years or older, individuals with a history of stomach ulcers or bleeding disorders, patients concurrently using anticoagulants or steroid medications, those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or others), individuals consuming three or more alcoholic beverages daily while using this product, or those who exceed the recommended dosage or duration of use.

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is 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 excess of the recommended dosage or for extended periods.

Monitoring and Consultation Healthcare professionals should advise patients 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, patients should seek medical advice if they exhibit symptoms of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Patients should also be instructed to stop use and consult a healthcare provider if pain worsens or persists beyond 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new or unexpected symptoms arise. Regular monitoring and patient education are essential to mitigate the risks associated with ibuprofen use.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, which contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID).

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, and blisters. In the event of an allergic reaction, patients should discontinue use immediately and seek medical assistance.

The use of this NSAID is also associated with a risk of severe stomach bleeding, particularly 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. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods. Patients should be aware of symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, and leg swelling.

Common adverse reactions may include worsening pain that persists beyond 10 days, fever that worsens or lasts more than three days, and the presence of redness or swelling in the affected area. Patients are advised to consult a healthcare professional if any new or unexpected symptoms arise.

Before using this product, patients should consult a doctor if they have experienced serious side effects from pain relievers or fever reducers, have a history of stomach issues such as heartburn, or 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 medical advice if taking a diuretic or if under a physician's care for any serious condition. Furthermore, patients taking aspirin for cardiovascular protection should be aware that ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen has been observed to potentially diminish the antiplatelet effect of aspirin when administered concurrently. This interaction may lead to an increased risk of cardiovascular events. Therefore, it is advisable to monitor patients closely for any signs of cardiovascular complications when these medications are used together.

No additional drug interactions or laboratory test interactions have been reported.

Packaging & NDC

Below are the non-prescription pack sizes of Uline 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 for symptom relief. 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 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 contact a Poison Control Center without delay.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding when using this medication. Therefore, it is crucial to exercise caution when prescribing to this population.

In geriatric patients, it is recommended that the smallest effective dose be utilized to minimize potential adverse effects. Due to their increased sensitivity to side effects, older adults may require careful monitoring during treatment.

Healthcare providers should ensure that elderly patients do not exceed the recommended dosage or duration of use, as they may be more susceptible to the side effects associated with nonsteroidal anti-inflammatory drugs (NSAIDs). Close observation and appropriate dose adjustments may be necessary to ensure safety and efficacy in this demographic.

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 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 ibuprofen in pregnant patients, especially in the later stages of pregnancy.

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 this medication in breast milk or its effects on breastfed infants. Therefore, healthcare providers should carefully consider the potential risks and benefits when prescribing this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further management.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless specifically 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. Additionally, serious cardiovascular events, such as myocardial infarction and stroke, have been reported. Instances of severe allergic reactions, including anaphylaxis and angioedema, have also been documented. Skin reactions, notably Stevens-Johnson syndrome and toxic epidermal necrolysis, have been observed in postmarketing reports. Furthermore, elevated blood pressure has been noted in patients taking ibuprofen, along with cases of hepatotoxicity, including liver failure.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important to counsel patients against using this product right before or after heart surgery.

Patients should be instructed to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. They should also be advised to seek medical attention if they exhibit symptoms of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Healthcare providers should remind patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts longer than 3 days, if there is redness or swelling in the painful area, or if any new or unexpected symptoms arise.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. It is also essential to encourage patients to consult a doctor before use if they have a history of problems or serious side effects from pain relievers or fever reducers, or if the stomach bleeding warning applies to them.

Patients should be counseled to seek medical advice before using this medication if they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they have had a stroke. They should also be advised to consult a doctor before use if they are taking a diuretic.

Furthermore, patients should be informed to speak with a doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin. Lastly, patients should be encouraged to consult a doctor or pharmacist before use if they are under medical care for any serious condition or if they are taking any other medications.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the product at a temperature range of 68-77°F (20-25°C). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Opened or torn packets must not be used to maintain product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)