Ibuprofen

Description

H-E-B® Ibuprofen Tablets USP contain 200 mg of ibuprofen, the active ingredient comparable to that found in Motrin® IB Ibuprofen Caplets. These nonsteroidal anti-inflammatory drug (NSAID) tablets serve as a pain reliever and fever reducer, indicated for the relief of body aches and pains. The product is presented in a package containing 50 coated caplets, each designed in a capsule shape for ease of ingestion.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular 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

Adults and children 12 years and older are advised to take 1 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does 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 recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, due to the risk of severe hypersensitivity reactions. Additionally, the product should not be used immediately before or after heart surgery, as it may interfere with postoperative recovery and increase the risk of complications.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may 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 is associated with an increased risk of severe stomach bleeding. The likelihood of experiencing such adverse effects is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, are taking 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 be aware that NSAIDs, excluding aspirin, are linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use the medication in excess of the recommended dosage or for extended periods.

In cases of overdose, immediate medical attention is required. Healthcare providers should advise patients to contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Patients should be instructed to discontinue use and consult a physician if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, they should seek medical advice if they exhibit symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. Other reasons to stop use 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 affected area, or the emergence of any new symptoms.

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 hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

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 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.

Additionally, NSAIDs, excluding aspirin, are 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 higher doses or for extended periods.

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 experiencing 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, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using ibuprofen, patients should consult a healthcare provider 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 a history of stomach issues such as heartburn. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical advice prior to use. Additionally, patients taking diuretics or aspirin for heart attack or stroke should consult a healthcare professional, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, patients should be advised to avoid concurrent use of ibuprofen and aspirin for these indications.

When considering the use of ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen, caution is warranted. The combination of these medications may increase the risk of adverse effects, particularly gastrointestinal complications.

The concomitant use of ibuprofen with anticoagulants or steroid medications is associated with an elevated risk of gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and to consider dosage adjustments or alternative therapies as necessary.

Additionally, caution is recommended when ibuprofen is used in conjunction with diuretics. Monitoring of renal function and blood pressure may be necessary to mitigate potential adverse effects.

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 and adults 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 may have an increased risk of severe stomach bleeding, particularly those aged 60 years and older. Healthcare providers should exercise caution when prescribing this medication to this population, as the likelihood of gastrointestinal complications may be heightened.

Additionally, the risk of cardiovascular events, including heart attack, heart failure, and stroke, is elevated in geriatric patients who exceed the recommended dosage or duration of treatment. It is essential for healthcare providers to monitor elderly patients closely and consider appropriate dose adjustments to mitigate these risks. Regular assessment of the patient's overall health status and adherence to prescribed guidelines is advised to ensure safe and effective use of the medication in this demographic.

Pregnancy

Pregnant patients and women of childbearing potential should consult a healthcare 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 developing fetus and lead to complications during delivery. The potential fetal impacts associated with ibuprofen use during late pregnancy warrant careful consideration and professional guidance.

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 ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may influence the management of therapy in individuals with reduced kidney function. Monitoring and appropriate dosing adjustments may be necessary to ensure safety and efficacy in this population.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects due to impaired drug metabolism. Close monitoring of liver function tests is recommended to ensure safety and efficacy.

Additionally, patients with a history of liver disease, including cirrhosis, should be evaluated for potential contraindications related to their hepatic status. Careful consideration should be given to the overall health of patients with concurrent conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these factors may further complicate treatment decisions.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, and the appropriate medical response may vary depending on the specific circumstances and the substance involved. It is essential for healthcare providers to assess the patient's condition thoroughly and initiate supportive care as needed.

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 non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, or individuals concurrently using blood-thinning (anticoagulant) or steroid medications. There is also an increased risk of heart attack, heart failure, and stroke, especially in patients who use the product in excess of the recommended dosage or for extended periods.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended that patients take the medication with food or milk if they experience stomach upset.

Patients should be encouraged to consult with their healthcare provider before using this medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Additionally, it is important for patients to discuss their medical history with their healthcare provider, particularly if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them.

Healthcare providers should also inquire about any existing conditions that may affect the use of this medication, including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients taking diuretics should be advised to consult their healthcare provider prior to use.

Furthermore, patients should be informed to speak with their doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the cardiovascular benefits of aspirin. It is also prudent for patients to consult their healthcare provider or pharmacist if they are under care for any serious condition or if they are taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to high humidity and excessive heat, particularly temperatures exceeding 40°C (104°F). For tracking purposes, the lot number and expiration date can be found on the end panel of the packaging.

Additional Clinical Information

Patients should take the medication orally, with a recommended dosage of one caplet every 4 to 6 hours while symptoms persist. If pain or fever does not adequately respond to one caplet, two caplets may be taken. However, patients should not exceed six caplets in a 24-hour period unless directed by a healthcare professional.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional before use. It is particularly important to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should keep the medication out of reach of children and seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

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)