Ibuprofen

Description

CVP® HEALTH contains ibuprofen as its active ingredient, formulated as ibuprofen tablets USP. Each tablet has a strength of 200 mg and is indicated for use as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). The product is packaged in a quantity of 50 coated tablets, each containing 200 mg of ibuprofen.

The product features a tamper-evident safety seal; it should not be used if the seal under the cap is broken or missing. This product is not manufactured or distributed by PF Consumer Healthcare 1 LLC, the owner of the registered trademark Advil® Tablets. It is distributed by Consumer Value Products, Inc., located at P.O. Box 6115, Temple, Texas 76502, and is available at CVPproducts.com.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including menstrual cramps, toothache, the common cold, backache, headache, 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 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 skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives. 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 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, being aged 60 years or older, taking other medications that contain NSAIDs (such as aspirin, ibuprofen, or naproxen), having a history of stomach ulcers or bleeding disorders, or consuming three or more alcoholic beverages daily while using this product.

Furthermore, NSAIDs, excluding aspirin, are linked to 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 cases of 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 signs of stomach bleeding, which may manifest as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, leg swelling, slurred speech, or weakness on one side of the body, warrant immediate medical evaluation.

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 may experience a range of adverse reactions associated with the use of this product, which contains an NSAID. Serious adverse reactions include severe allergic reactions, which may manifest as skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives, particularly in individuals with a known allergy to aspirin.

The use of this NSAID is also associated with an increased risk of severe stomach bleeding, especially in patients who take more than the recommended dose or for an extended duration. Additional risk factors include concurrent use of blood thinners or steroid medications, being aged 60 or older, having a history of stomach ulcers or bleeding problems, consuming three or more alcoholic drinks daily, or using other NSAIDs such as aspirin, ibuprofen, or naproxen.

Furthermore, NSAIDs, excluding aspirin, have been linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened with prolonged use or exceeding the recommended dosage.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, leg swelling, slurred speech, or weakness on one side of the body, also warrant immediate medical attention. Additionally, patients should 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 painful area, or if any new symptoms arise.

It is recommended that patients consult a healthcare provider prior to use if they have a history of stomach issues, are on diuretics, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients should also inform their healthcare provider if they are under treatment for any serious condition or if they are taking aspirin for cardiovascular protection, as ibuprofen may diminish the effectiveness of aspirin.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable to avoid concurrent use of ibuprofen with aspirin in patients who are taking aspirin for these indications.

Additionally, the concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of severe gastrointestinal bleeding. Close monitoring for signs of gastrointestinal bleeding is recommended in patients receiving this combination. Adjustments to the dosage of ibuprofen or the anticoagulant/steroid may be necessary based on the clinical scenario and patient response.

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 while symptoms persist. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets 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. 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 elevated 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 potential cardiovascular risks. Regular assessment and monitoring of elderly patients are advised 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 gestation 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 consider the potential benefits and risks when prescribing this medication to pregnant patients, especially in the later stages of pregnancy.

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 this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use 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 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 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 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 have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including cases of anaphylaxis, angioedema, and various skin reactions such as rash, pruritus, and urticaria. Gastrointestinal adverse events have also been reported, encompassing gastrointestinal bleeding, ulceration, and perforation.

Cardiovascular events, including myocardial infarction and stroke, have been documented. Additionally, renal adverse events such as acute renal failure and interstitial nephritis have been observed. Hepatic adverse events, including elevations in liver enzymes and instances of hepatitis, have been reported as well.

Hematologic adverse events, including thrombocytopenia and aplastic anemia, have been noted. Furthermore, central nervous system events such as headache, dizziness, and drowsiness have been identified in the postmarketing experience.

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 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 the medication if they have a history of stomach problems, such as heartburn, or if they are currently taking a diuretic. Additionally, it is important for patients to discuss their medical history with their healthcare provider, particularly if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they have previously experienced a stroke.

Healthcare providers should also inform patients to seek medical advice before using the medication if they have been warned about stomach bleeding. Patients with a history of problems or serious side effects from pain relievers or fever reducers should also consult their healthcare provider prior to use.

Furthermore, patients should be advised to speak with their doctor or pharmacist if they are under care for any serious condition. It is crucial for patients taking aspirin for heart attack or stroke to consult their healthcare provider, as ibuprofen may diminish the cardioprotective effects of aspirin. Lastly, patients should be encouraged to discuss any other medications they are taking with their healthcare provider or pharmacist to avoid potential interactions.

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 20º-25ºC (68º-77ºF) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF).

For proper inventory management, the expiration date and lot number are located on the end flap of the packaging. This information is crucial for ensuring the product's quality and safety throughout its shelf life.

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)