Ibuprofen 100, Ibuprofen 250

Description

This product contains Ibuprofen as the active ingredient, serving as a pain reliever and fever reducer. It provides temporary relief from pain, fever, and inflammation, effectively soothing muscle aches and minor arthritis pain. The formulation is non-drowsy and aspirin-free. Each product unit includes 100 tablets, with 2 tablets sealed in tamper-evident packets for safety and convenience. These quality comfort tablets are specifically formulated and packaged for workplace use, adhering to ANSI Z308.1-2015 standards. This product is not manufactured or distributed by Pfizer Consumer Healthcare, the owner of the registered trademark Advil®.

Uses and Indications

This drug is indicated for the temporary relief of fever and minor aches and pains associated with various conditions, including the common cold, backache, headache, toothache, arthritis, muscular aches, and menstrual cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults are advised to take 1 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. However, the total daily dosage should not exceed 6 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other 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

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

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries the risk of causing severe stomach bleeding. The likelihood of this adverse effect is heightened in certain populations, including individuals aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, and patients concurrently using blood thinners (anticoagulants) or steroid medications. Additionally, the risk increases for individuals taking other NSAIDs, whether prescription or over-the-counter (such as aspirin, ibuprofen, or naproxen), those consuming three or more alcoholic beverages daily while using this product, and those who exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a physician prior to using ibuprofen if any of the following conditions apply: a history of stomach bleeding, previous stomach issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics should also seek medical advice before use. Furthermore, it is essential to inquire about the concurrent use of other NSAIDs, anticoagulants, or any medications for serious conditions.

In the event of an allergic reaction, patients must stop using ibuprofen and seek emergency medical help immediately. In cases of overdose, it is crucial to contact a Poison Control Center or seek medical assistance without delay.

Patients should discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain that worsens or does not improve. Additional symptoms warranting medical consultation include fever that worsens or lasts more than three days, redness or swelling in the painful area, or the emergence of any new symptoms.

Side Effects

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

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

The use of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), carries a warning regarding the potential for severe stomach bleeding. The risk of this serious adverse reaction is heightened 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 while using the product, or exceed the recommended dosage or duration of use.

Long-term continuous use of ibuprofen may also increase the risk of cardiovascular events, such as heart attack or stroke.

Patients should be vigilant for signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or noticing that pain worsens or lasts longer than 10 days. Additionally, if fever worsens or lasts more than three days, or if redness or swelling occurs in the painful area, patients should stop use and consult a healthcare provider. The appearance of any new symptoms should also prompt a discussion with a doctor.

Before using ibuprofen, patients are encouraged to consult a healthcare professional 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, or kidney disease. It is also advisable to seek medical advice if they are taking diuretics, other NSAIDs (whether prescription or nonprescription), or anticoagulant medications, or if they are under a doctor's care for any serious condition.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking any other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter. The concomitant use of multiple NSAIDs may increase the risk of adverse effects, including gastrointestinal bleeding and renal impairment.

Additionally, individuals on anticoagulant therapy should seek advice from a healthcare provider before initiating this medication. The combination of this drug with blood thinners may heighten the risk of bleeding complications. Monitoring for signs of bleeding and appropriate dosage adjustments may be necessary based on the clinical scenario and the specific anticoagulant used.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen 100, Ibuprofen 250 (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. The safety and efficacy of this medication in this age group have not been established, and specific dosing recommendations are not provided for children in this category.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing medications that may exacerbate this risk in this population. It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies as necessary to ensure their safety.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is especially important to avoid the use of ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child and lead to complications during delivery. Healthcare providers should carefully consider the potential fetal impacts and weigh the benefits against the 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 during the last three months of pregnancy 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, caution is recommended when considering its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment. In patients with significant liver conditions such as liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity.

Monitoring of liver function tests is recommended throughout the treatment course to ensure safety and efficacy. Special caution should be exercised in patients with concurrent conditions such as high blood pressure, heart disease, or kidney disease, as these may further complicate the management of hepatic impairment.

Healthcare providers should evaluate the overall clinical status of patients with compromised liver function and consider the potential need for more frequent monitoring and dosage modifications based on individual patient response and laboratory findings.

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 aware that the symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of 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. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of ibuprofen. Reports include 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, cases of anaphylactic reactions, including shock, have been reported.

Cardiovascular events, including myocardial infarction and stroke, have been noted in patients using ibuprofen. There have been instances of elevated blood pressure among users. Furthermore, postmarketing surveillance has indicated an increased risk of heart attack and stroke associated with the long-term use of ibuprofen.

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 should be informed to discontinue use 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. Additionally, they should seek medical advice if pain worsens or persists for more than 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.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. It is important to communicate that long-term continuous use may increase the risk of heart attack or stroke.

Patients should be encouraged to consult a doctor before use if the warning regarding stomach bleeding applies to them, 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, or kidney disease. They should also be advised to seek medical guidance if they are taking a diuretic.

Furthermore, patients should be instructed to ask a doctor or pharmacist before using this medication if they are taking any other drug containing a nonsteroidal anti-inflammatory drug (NSAID), any blood-thinning (anticoagulant) medication, are under a doctor's care for any serious condition, or are taking any other drugs.

Storage and Handling

The product is supplied in packets that must not be used if opened or torn. It should be stored at a temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures above 40°C (104°F). Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

Adults are advised to take 1 tablet every 4 to 6 hours as needed for symptoms. If pain or fever does not respond to 1 tablet, 2 tablets may be taken, but the total should not exceed 6 tablets in a 24-hour period unless directed by a healthcare professional. For children under 12 years, consultation with a doctor is recommended before administration.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless specifically directed by a doctor, 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 100, Ibuprofen 250, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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