Ibuprofen

Description

Ibuprofen Capsules are formulated to deliver 200 mg of ibuprofen per softgel. Each bottle contains a total of 40 capsules. The product is identified by the National Drug Code (NDC) number 53345-039-02. These capsules are manufactured in China and should be stored at a temperature range of 20-25°C (68-77°F).

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 aged 12 years and older are advised to take 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 dosage of 2 capsules may be administered. It is imperative that the total daily 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 recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other 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 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, 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 using ibuprofen if they have experienced serious side effects from pain relievers or fever reducers, if the stomach bleeding warning is applicable, or if they have a history of gastrointestinal issues such as heartburn. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, as well as those taking diuretics, should seek medical advice before use.

It is also essential for patients to discuss their use of aspirin for cardiovascular protection with their healthcare provider, as ibuprofen may diminish the cardioprotective effects of aspirin. Patients under medical supervision for serious conditions or those taking other medications should also consult their doctor or pharmacist before using ibuprofen.

In the case of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients should discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, fever intensifies or persists beyond three days, redness or swelling occurs in the affected area, or any new symptoms arise, medical consultation is advised.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen. Serious adverse reactions include severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning regarding the potential for stomach bleeding. The risk of this serious adverse reaction is heightened in patients who are aged 60 years or older, have a history of stomach ulcers or bleeding problems, are concurrently taking blood-thinning medications (anticoagulants) or steroids, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients should discontinue use and seek medical attention if they experience any signs indicative of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, if redness or swelling occurs in the painful area, or if any new symptoms arise, patients are advised to consult a healthcare professional.

Before using ibuprofen, 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 is applicable, or if they have a history of stomach problems 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 taking aspirin for the prevention of heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin. It is recommended that individuals under a doctor's care for any serious condition or those taking other medications consult with a healthcare provider or pharmacist before using ibuprofen.

Drug Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are administered concurrently for the prevention of heart attack or stroke. It is advisable to monitor patients closely for any signs of reduced efficacy of aspirin in such scenarios. Consideration should be given to the timing of administration, as taking ibuprofen at least 30 minutes after or 8 hours before aspirin may help mitigate this interaction.

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 for symptom relief. If pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important not to exceed 6 capsules within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Monitoring for signs of gastrointestinal bleeding is advised, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits should be conducted to ensure the safety of elderly patients receiving this treatment.

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 during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery.

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

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have underlying conditions such as kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment. Caution is advised in patients with reduced kidney function, as they may be at increased risk for adverse effects.

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 to assess liver function and consider potential risks associated with the use of this medication in individuals with compromised liver function. Monitoring of liver parameters may be warranted to ensure safety and efficacy in this patient population. Adjustments to dosage or treatment regimens may be necessary based on the severity of hepatic impairment and the patient's overall health status.

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 potential overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical scenario.

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 detailed findings 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 included 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 myocardial infarction and stroke, have been reported. Some patients experienced allergic reactions, which included anaphylaxis and angioedema. Furthermore, elevated blood pressure has been noted in certain patients using ibuprofen, along with instances of gastrointestinal perforation.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should also be informed to take the medication with food or milk if they experience any stomach upset. It is important for healthcare providers to emphasize that exceeding the recommended dosage or using the medication for a longer duration than prescribed may increase the risk of heart attack or stroke.

Storage and Handling

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

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 during the last trimester 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)