Dg Health Ibuprofen

Description

Ibuprofen Tablets are formulated as 200 mg capsule-shaped tablets, serving as a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief and fever reduction. Each bottle contains 50 caplets, with the actual size of the caplet designed for ease of swallowing.

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

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 as follows: take 1 caplet every 4 to 6 hours while symptoms persist. If pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. However, it is imperative not to exceed a total of 6 caplets within a 24-hour period unless specifically 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 ibuprofen or 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 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 carries a risk of severe stomach bleeding. The likelihood of experiencing this adverse effect 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.

NSAIDs, with the exception of aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for an extended period.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, 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.

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, have been 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 experienced 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 interact with several classes of medications, leading to potential adverse effects or diminished therapeutic efficacy.

Pharmacodynamic Interactions

The concomitant use of ibuprofen with anticoagulants or steroid medications may elevate the risk of bleeding. Healthcare providers should monitor patients closely for signs of bleeding and consider alternative therapies if necessary.

Additionally, ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attacks or strokes. It is advisable for patients to consult their healthcare provider regarding the timing and use of these medications to ensure optimal therapeutic outcomes.

Pharmacokinetic Interactions

The use of ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as aspirin and naproxen, can significantly increase the risk of gastrointestinal bleeding. Patients should be counseled to avoid the concurrent use of multiple NSAIDs.

Furthermore, caution is warranted when ibuprofen is used in conjunction with diuretics, as this combination may lead to reduced diuretic efficacy and potential fluid retention.

Patient Considerations

Patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should seek medical advice prior to using ibuprofen. These conditions may influence the safety and effectiveness of ibuprofen therapy, necessitating careful evaluation and possible dosage adjustments.

Packaging & NDC

Below are the non-prescription pack sizes of Dg Health Ibuprofen (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 for symptom relief. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may experience an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal complications.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), excluding aspirin, is associated with an elevated risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is further heightened in elderly patients who exceed the recommended dosage or duration of treatment. Therefore, careful consideration of dosage adjustments and ongoing assessment of the patient's cardiovascular status is advised when prescribing NSAIDs to geriatric patients.

Pregnancy

Pregnant patients and women 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 consider the potential benefits and risks when prescribing this medication to 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 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 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 may require careful consideration regarding dosing adjustments and monitoring. It is essential to assess renal function prior to initiating treatment, particularly in those with a history of kidney disease. Patients with reduced kidney function may experience altered drug clearance, necessitating modifications to the standard dosing regimen. Regular monitoring of renal function is advised to ensure safety and efficacy in this population. Additionally, healthcare professionals should remain vigilant for potential complications associated with concurrent conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these may further impact renal function and overall treatment outcomes.

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 significant liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with hepatic impairment should be evaluated for the presence of comorbid conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these factors may further complicate treatment and necessitate additional precautions.

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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence patient outcomes. 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 should be initiated as per established protocols, which may include supportive care and symptomatic treatment. It is essential for healthcare providers to remain vigilant and prepared to address any complications that may arise during the management of an overdose.

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 specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the medication. Reports indicate the occurrence of allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, stomach bleeding has been noted, particularly in patients aged 60 years or older or those with a history of stomach ulcers or bleeding problems.

There is an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, especially with prolonged use or higher than directed doses. Serious cardiovascular events have been reported in association with the use of NSAIDs, such as ibuprofen.

Liver damage has also been reported, characterized by elevated liver enzymes and hepatitis. Renal adverse events, including acute kidney injury and interstitial nephritis, have been documented. Furthermore, gastrointestinal adverse events, such as perforation and ulceration, which can be fatal, have been observed.

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported. Other adverse reactions include dizziness, headache, and gastrointestinal discomfort.

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.

Providers should encourage patients to consult with a doctor prior to use if they have experienced problems or serious side effects from pain relievers or fever reducers. Additionally, patients should be informed to ask a doctor before use if they have a history of stomach issues, such as heartburn, or if the stomach bleeding warning applies to them.

Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also be advised to consult a doctor before using the medication. Furthermore, it is important for patients to discuss their use of diuretics with their healthcare provider prior to use.

Healthcare providers should inform patients that if they are taking aspirin for heart attack or stroke, they should consult a doctor or pharmacist before using this medication, as ibuprofen may reduce the effectiveness of aspirin. Lastly, patients should be encouraged to speak with their doctor 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) to maintain its efficacy. 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

Adults and children aged 12 years and older are advised to take 1 caplet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 caplet, 2 caplets may be used, but the total should not exceed 6 caplets in a 24-hour period unless directed by a physician. For children under 12 years, consultation with a doctor is recommended.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding, particularly noting that ibuprofen should not be used after 20 weeks of pregnancy unless specifically directed by a doctor due to potential risks to the unborn child or complications during delivery. It is also important to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

Drug Information (PDF)

This file contains official product information for Dg Health Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)