Ibuprofen

Description

Ibuprofen Tablets USP contain 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief and fever reduction. Each bottle contains 50 capsule-shaped tablets. The product is identified by NDC 11822-0393-5 and is designed with a tamper-evident feature; do not use if the imprinted safety seal under the cap is broken or missing. This product is distributed by Rite Aid, located at 200 Newberry Commons, Etters, PA 17319. It is important to note that this product is not manufactured or distributed by Kenvue Inc., the owner of the registered trademark Motrin® IB Caplets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including backache, muscular aches, 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 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, a maximum of 2 caplets may be administered. However, the total daily dosage must not exceed 6 caplets 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 the following situations:

Patients should not use this product immediately before or after heart surgery due to potential complications associated with surgical recovery. Additionally, individuals with a history of allergic reactions to any other pain reliever or fever reducer should avoid this product to prevent the risk of severe allergic responses.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include shock, facial swelling, blisters, rash, hives, skin reddening, and asthma (wheezing). 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 this adverse effect is increased in patients who are 60 years of age or older, take higher doses or use the medication for an extended period, are concurrently using blood thinners (anticoagulants) or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), have a history of stomach ulcers or bleeding disorders, or consume three or more alcoholic beverages daily while using this product.

Additionally, NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for longer than advised.

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, concurrent use of diuretics, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients with a history of adverse reactions to pain relievers or fever reducers should also seek medical advice before use.

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

Patients should be instructed to discontinue use and contact their 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. 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, warrant immediate medical evaluation. Furthermore, if pain persists or worsens beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new symptoms arise, patients should seek medical advice promptly.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

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

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 aged 60 years or older, those who take the medication for longer than directed, individuals on blood thinners or steroid drugs, and those who consume three or more alcoholic drinks daily while using the product. Additionally, patients with a history of stomach ulcers or bleeding problems are at increased risk.

There is also an elevated risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, particularly in patients 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, vomiting blood, having bloody or black stools, or 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, 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 painful area, or any new symptoms arise, patients should seek medical advice.

Before initiating treatment with ibuprofen, patients should consult a healthcare provider if they have a history of stomach issues, such as heartburn, or if they are taking diuretics. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical guidance prior to use, especially if they have experienced serious side effects from pain relievers or fever reducers in the past.

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. This interaction is clinically significant and warrants consideration when prescribing these medications together.

Patients with a known allergy to aspirin may experience severe allergic reactions when taking ibuprofen. Caution is advised in this population to prevent potential adverse effects.

The use of ibuprofen in conjunction with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. Healthcare providers should monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies as necessary.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, is associated with an increased risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used in higher doses or for extended periods. It is advisable to limit the duration and dosage of ibuprofen to mitigate these risks. Regular monitoring of cardiovascular status may be warranted in patients requiring prolonged NSAID therapy.

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 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, a dose of 2 caplets may be administered. It is important not to exceed 6 caplets in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems. Therefore, special precautions should be exercised in this population to mitigate potential complications.

Additionally, the risk of heart attack and stroke is elevated in geriatric patients who exceed the recommended dosage or duration of use. It is essential for healthcare providers to closely monitor elderly patients for these adverse effects and to consider appropriate dose adjustments or alternative therapies when necessary.

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 could 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 healthcare professional before using this medication while breastfeeding. There is a particular concern regarding the use of ibuprofen during pregnancy, especially after 20 weeks, as it may pose risks to the unborn child and lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for lactating mothers considering this treatment.

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 renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual’s health status.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and closely monitored throughout the treatment process. It is advisable to have access to the relevant medical history and any substances ingested to facilitate appropriate management.

In summary, immediate action is critical in the case of an overdose, and healthcare professionals should be prepared to provide comprehensive care and support to affected individuals.

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 specific non-teratogenic effects or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

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 cardiovascular events, including heart attack and stroke, have been reported. Other adverse reactions include allergic reactions, such as anaphylaxis and angioedema. Instances of elevated blood pressure in patients taking ibuprofen have been noted, as well as reports of worsening asthma symptoms.

Patient Counseling

Healthcare providers should advise patients to keep the 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 take the medication 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 they have a history of stomach problems, such as heartburn, or if they are subject to stomach bleeding warnings.

Additionally, patients should be advised to discuss their current medications with their healthcare provider, particularly if they are taking a diuretic, have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or have had a stroke. They should also be encouraged to inform their healthcare provider if they have experienced problems or serious side effects from pain relievers or fever reducers in the past.

Patients under a doctor's care for any serious condition should be advised to consult their doctor or pharmacist before using this medication. Furthermore, it is crucial to inform patients that if they are taking aspirin for heart attack or stroke prevention, they should seek advice from a healthcare professional, as ibuprofen may diminish the effectiveness of aspirin. Lastly, patients should be reminded to discuss any other medications they are taking with their healthcare provider or pharmacist prior to use.

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 temperature range of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). For proper tracking and quality assurance, the expiration date and lot number are located on the end flap of the packaging.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial 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.

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)