Ibuprofen

Description

Ibuprofen is presented in the form of liquid-filled softgels, each containing 200 mg of the active ingredient. It functions as a nonsteroidal anti-inflammatory drug (NSAID) that serves as a pain reliever and fever reducer. The product is distributed by Nash Finch Company, located at 7600 France Ave S, Minneapolis, MN 55435. The trademark Advil® Liqui-Gels® is owned by Pfizer Consumer Healthcare, and this product is not manufactured or distributed by them. For more information, visit www.ourfamilyfoods.com.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscle aches, minor pain of arthritis, toothache, backache, the common cold, and menstrual cramps. 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 orally. For adults and children aged 12 years and older, the recommended dosage is 1 capsule every 4 to 6 hours as needed while symptoms persist. If the initial dose of 1 capsule does not adequately relieve pain or fever, a maximum of 2 capsules may be taken. It is imperative that the total dosage does not exceed 6 capsules 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 physician before administration. The smallest effective dose should always be utilized, and patients should not exceed the recommended dosage.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. 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 increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, previous adverse reactions to pain relievers or fever reducers, gastrointestinal issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are currently taking a diuretic. Additionally, patients should seek guidance from a doctor or pharmacist if they are under medical care for any serious condition, are using aspirin for cardiovascular protection, or are taking any other medications.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted.

Patients are advised to discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. 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 symptoms arise, medical advice should be sought promptly.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

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, skin reddening, rash, and blisters.

Additionally, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the risk of severe stomach bleeding. The likelihood of this adverse reaction increases 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 use other NSAIDs concurrently.

Patients are advised to discontinue use and consult a healthcare professional if they experience signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other reasons to seek medical advice include worsening pain lasting more than 10 days, a fever that worsens or persists beyond three days, the presence of redness or swelling in the painful area, or the emergence of any new symptoms.

Before using ibuprofen, patients should consult a healthcare provider if any of the aforementioned stomach bleeding risk factors apply, if they have experienced serious side effects from pain relievers or fever reducers, or if they have a history of stomach issues such as heartburn. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, as well as individuals taking diuretics, should also seek medical advice prior to use.

Furthermore, patients under a doctor's care for any serious condition or those taking aspirin for heart attack or stroke should consult a healthcare professional, as ibuprofen may diminish the cardioprotective effects of aspirin. It is also recommended to discuss the use of ibuprofen with a doctor or pharmacist if other medications are being taken.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. This interaction is particularly relevant for patients relying on aspirin for its antiplatelet properties.

The concomitant use of ibuprofen with anticoagulants or corticosteroids is associated with an increased risk of gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring for signs of bleeding in patients receiving these combinations.

Additionally, the use of ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter, such as aspirin or naproxen, may further elevate the risk of gastrointestinal bleeding. It is advisable for patients to consult with a healthcare professional prior to initiating ibuprofen if they are currently taking any other medications, particularly those that may interact.

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 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, a dose of 2 capsules may be administered. It is important to note that the maximum dosage should not exceed 6 capsules within a 24-hour period, unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of stomach bleeding when using this medication. It is essential for healthcare providers to assess the individual risk factors of geriatric patients, especially if they present with conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Before initiating treatment, healthcare providers should advise elderly patients to consult with their physician if they have any of the aforementioned conditions or if they are concerned about the stomach bleeding warning. Close monitoring and appropriate dose adjustments may be necessary to ensure the safety and efficacy of the treatment in this population.

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 during the last trimester unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. The potential adverse effects on fetal outcomes necessitate careful consideration and professional guidance in managing pain or inflammation in pregnant individuals.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy 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 available 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 asthma. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of kidney disease.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as 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 necessary to ensure appropriate management and to mitigate potential risks associated with the use of this medication in individuals with hepatic impairment.

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 specific symptoms of an 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 the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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 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 documented gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been reported.

Additionally, cases of anaphylactic reactions, such as angioedema and bronchospasm, have been observed. Cardiovascular events, including myocardial infarction and stroke, have been noted in patients using ibuprofen. There have been instances of elevated blood pressure among users of the medication.

Other reported adverse events include dizziness, headache, and tinnitus. Hypersensitivity reactions, such as rash and urticaria, have also been documented in the postmarketing setting.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center in the event of an overdose. It is important to inform patients that they should not use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using the 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 discontinue use and seek medical advice 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 encouraged to take it with food or milk if they experience stomach upset. It is crucial to inform patients that the risk of heart attack or stroke may increase if they use more than the recommended dose or for a longer duration than directed.

Healthcare providers should remind patients to consult a doctor before use if the warning regarding stomach bleeding applies to them, or if they have a history of problems or serious side effects from taking pain relievers or fever reducers. Patients with a history of stomach issues, such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should also be advised to seek medical guidance prior to use. Furthermore, patients taking a diuretic or under a doctor's care for any serious condition should consult their healthcare provider or pharmacist before using this medication.

Lastly, patients should be informed to discuss with their doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the benefits of aspirin. They should also be encouraged to consult their healthcare provider or pharmacist if they are taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20º to 25ºC (68º to 77ºF). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF). Additionally, the product must be protected from light to maintain its integrity and efficacy.

Additional Clinical Information

No further data are available.

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)