Ibuprofen

Description

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. The formulation consists of coated tablets, each containing 200 mg of ibuprofen. The product is packaged in a quantity of 100 tablets and is free from dyes.

The National Drug Code (NDC) for this product is 59779-438-12. It is distributed by CVS Pharmacy, Inc., located at One CVS Drive, Woonsocket, RI 02895. The product features a tamper-evident safety seal, and it should not be used if the seal is broken or missing.

This formulation is comparable to the active ingredient found in Advil®, although it is not manufactured or distributed by Haleon US Holdings LLC, the owner of the registered trademark Advil®. The copyright for this product is held by CVS/pharmacy, with customer service available at 1-800-SHOP CVS. A 100% money-back guarantee is offered, as detailed in the return policy available at CVS.com/returnpolicy.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothache, backache, menstrual cramps, the common cold, muscular aches, 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 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a maximum of 2 tablets may be taken. However, the total dosage must not exceed 6 tablets 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 patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include rash, facial swelling, asthma (wheezing), hives, skin reddening, shock, and blisters. Should any signs of an allergic reaction manifest, 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 such an event is heightened under certain conditions, including but not limited to: exceeding the recommended dosage or duration of use, concurrent use of anticoagulants or steroid medications, a history of stomach ulcers or bleeding disorders, consumption of three or more alcoholic beverages daily while using this product, being aged 60 years or older, or taking other medications that contain NSAIDs (such as aspirin, ibuprofen, or naproxen).

Furthermore, NSAIDs, with the exception of aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The risk escalates with the use of higher doses or prolonged duration beyond the recommended guidelines.

In the event of an overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center or seek emergency medical help without delay.

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, presence of bloody or black stools, vomiting blood, or persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke warrant immediate medical evaluation and include chest pain, slurred speech, leg swelling, difficulty breathing, or weakness localized to one side of the body.

Patients should also seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise. Regular monitoring and assessment of these parameters are essential for the safe use of ibuprofen.

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 rash, facial swelling, asthma (wheezing), hives, skin reddening, shock, 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 take higher doses or use the medication for extended periods, those on anticoagulants or steroid medications, individuals with a history of stomach ulcers or bleeding problems, patients consuming three or more alcoholic drinks daily, those aged 60 or older, and individuals taking other NSAIDs, whether prescription or over-the-counter, such as aspirin or naproxen.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is elevated when the medication is used in excess of the recommended dosage or duration.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs indicative of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Symptoms suggestive of heart problems or stroke, including chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, 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 initiating treatment with ibuprofen, patients should consult a healthcare provider if they have a history of stomach issues, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, those taking diuretics or who have experienced serious side effects from pain relievers or fever reducers should seek medical guidance prior to use.

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 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets within 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. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal bleeding, especially when prescribing medications that may exacerbate this risk.

Additionally, the risk of heart attack, heart failure, and stroke is heightened in geriatric patients who use the medication in excess of the recommended dosage or for an extended duration. Therefore, careful adherence to dosing guidelines is crucial in this population to mitigate these serious cardiovascular risks. Regular assessment and monitoring of elderly patients are recommended to ensure their safety while using this medication.

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 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 health professional before using this medication while breastfeeding. 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 this medication in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

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 their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

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 tests may be warranted 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 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 assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure appropriate management and intervention.

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

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to instruct patients to take the medication with food or milk if they experience stomach upset.

Patients should be encouraged to consult with their doctor before using this medication if they have a history of stomach problems, such as heartburn, or if they are subject to stomach bleeding warnings. Additionally, healthcare providers should recommend that patients discuss their medical history with their doctor if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they have previously experienced a stroke.

Patients taking diuretics should also be advised to consult their doctor prior to use. Furthermore, those who have experienced problems or serious side effects from pain relievers or fever reducers should seek medical advice before using this medication.

It is essential for patients under a doctor's care for any serious condition to consult with their doctor or pharmacist before use. Patients should also be informed that if they are taking aspirin for heart attack or stroke prevention, they should discuss this with their healthcare provider, as ibuprofen may reduce the effectiveness of aspirin. Lastly, patients should be encouraged to speak with their doctor or pharmacist if they are taking any other medications.

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°-25°C (68°-77°F) to maintain its efficacy. 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 medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly critical 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)