Mckesson Ibuprofen 200 mg

Description

No description information is available for the 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

The medication should be administered according to the following guidelines to ensure safe and effective use.

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 dose of 2 tablets may be taken. However, the total daily dosage must not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. It is important to utilize the smallest effective dose and to avoid use for longer than 10 days without medical supervision.

For children under 12 years of age, it is advised to consult a healthcare provider for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer, due to the potential for severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks to surgical outcomes and patient safety.

Warnings and Precautions

Patients should be informed of the following warnings and precautions associated with the use of ibuprofen.

Allergy Alert Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may 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 an NSAID, ibuprofen carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in patients who meet any of the following criteria:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently using anticoagulants or steroid medications

• Are taking other NSAIDs, whether prescription or over-the-counter (including aspirin, ibuprofen, naproxen, or others)

• Consume three or more alcoholic beverages daily while using this product

• 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 amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

Monitoring and Consultation Patients should be advised to discontinue use and consult a healthcare professional if they experience any of the following symptoms, which may indicate stomach bleeding:

• Feeling faint

• Vomiting blood

• Presence of bloody or black stools

• Persistent stomach pain

Additionally, patients should seek medical advice if they exhibit symptoms suggestive of heart problems or stroke, including:

• Chest pain

• Difficulty breathing

• Weakness localized to one side of the body

• Slurred speech

• Swelling in the legs

Patients should also stop use and consult a physician if:

• Pain worsens or persists beyond 10 days

• Fever worsens or lasts more than 3 days

• Redness or swelling occurs in the affected area

• Any new or unexpected symptoms arise

Emergency Medical Help In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately.

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 seek medical advice if they experience symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or 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 a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended that patients taking aspirin for cardiovascular protection consult a healthcare provider, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen has been observed to potentially decrease the antiplatelet effect of aspirin when administered concurrently. This interaction may lead to an increased risk of cardiovascular events. It is advisable for healthcare professionals 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 Mckesson Ibuprofen 200 mg (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 physician.

It is crucial 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. This product is intended for households without young children.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful monitoring and consideration when prescribing medications that may exacerbate this condition. Additionally, the likelihood of experiencing heart attack, heart failure, and stroke is elevated in older adults, especially when medications are used in excess of the recommended dosage or for prolonged periods.

To mitigate gastrointestinal discomfort, it is advisable for elderly patients to take medications with food or milk, as they may have more sensitive stomachs. Furthermore, it is crucial that elderly patients do not exceed a maximum of 6 tablets within a 24-hour period unless specifically directed by a healthcare provider, given their increased susceptibility to side effects.

Healthcare providers should also be vigilant in assessing the medical history of geriatric patients, particularly for those with a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. These conditions are more prevalent in older adults and may influence the safety and efficacy of treatment. Regular consultation with a healthcare professional is recommended to ensure appropriate management and monitoring of these patients.

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 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 this medication in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against the risks when considering the use of this medication in 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 individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.

For further guidance, healthcare professionals should refer to established protocols and consult relevant toxicology resources.

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 indicate occurrences of gastrointestinal bleeding, renal impairment, and cardiovascular events.

Gastrointestinal bleeding has been reported, particularly in patients with a history of gastrointestinal issues. Renal impairment has also been noted, especially among individuals with pre-existing kidney conditions or those experiencing dehydration. Additionally, cardiovascular events, including heart attack and stroke, have been documented, particularly in patients using ibuprofen at higher doses or for extended durations.

Patient Counseling

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

Patients must be informed not to use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be used right before or after heart surgery.

Patients should be counseled 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 persistent stomach pain. 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 leg swelling.

It is important to inform patients to discontinue use and consult a healthcare professional if their pain worsens or lasts longer than 10 days, if their fever worsens or persists for more than 3 days, if there is redness or swelling in the painful area, or if any new or unexpected symptoms arise.

Patients should be instructed to take the medication with food or milk if they experience stomach upset. Healthcare providers should encourage patients to consult a doctor before use if they have experienced problems or serious side effects from pain relievers or fever reducers in the past.

Patients should also be advised to seek medical advice if the warning regarding stomach bleeding applies to them, or if they have a history of stomach problems such as heartburn. Furthermore, it is essential to recommend that patients consult a doctor before use if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

Patients taking diuretics should be advised to consult a doctor before using this medication. Additionally, it is important to inform patients to speak with a doctor or pharmacist 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 packets at a temperature range of 68-77°F (20-25°C). Care should be taken to avoid exposure to excessive heat, specifically temperatures above 104°F (40°C). Opened or torn packets should 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 Mckesson Ibuprofen 200 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)