Dg Health Ibuprofen

Description

Ibuprofen Liquid Gels contain 200 mg of solubilized ibuprofen per capsule. This formulation serves as a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each package contains 160 liquid-filled capsules, designed for effective delivery of the active ingredient.

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 capsule every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be administered. However, it is imperative that the total 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 advised to consult a doctor before administration.

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be administered 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 such reactions 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 emergency 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 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.

Furthermore, 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 individuals who use the medication in excess of the recommended dosage or for extended periods.

Healthcare professionals should advise patients to seek immediate medical attention if they experience any signs of an allergic reaction. Additionally, patients should be instructed to discontinue use and consult a physician if they exhibit any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical evaluation.

Patients should be advised to stop use and consult a healthcare provider 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 vary in severity and frequency.

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. Additionally, the use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic drinks daily while using the product. Patients who exceed the recommended dosage or duration of use are also at increased risk.

Furthermore, NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use ibuprofen in excess of the directed dosage or for prolonged periods.

Common adverse reactions may include gastrointestinal symptoms, and patients are advised to discontinue use and consult a healthcare professional if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or 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. 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 affected area, or if any new symptoms arise.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended that patients under a doctor's care for serious conditions or those taking aspirin for cardiovascular protection discuss their use of ibuprofen, as it may diminish the cardioprotective effects of aspirin.

Drug Interactions

The concomitant use of ibuprofen with aspirin may diminish the cardioprotective effects of aspirin, particularly in patients using aspirin for the prevention of heart attacks or strokes. Therefore, it is advisable for patients to consult a healthcare professional before combining these medications.

Ibuprofen is associated with an increased risk of severe allergic reactions in individuals with a known allergy to aspirin. Caution is warranted in these patients, and alternative analgesics should be considered.

The use of ibuprofen may elevate the risk of serious cardiovascular events, including heart attack, heart failure, and stroke, especially when used in higher doses or for extended periods. Patients are advised to adhere strictly to the recommended dosage and duration of therapy.

Patients on anticoagulants or steroid medications should seek medical advice prior to initiating ibuprofen therapy to mitigate potential interactions and adverse effects.

Individuals taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription or over-the-counter options such as aspirin or naproxen, should consult a healthcare provider before using ibuprofen to avoid cumulative effects and increased risk of side effects.

Patients on diuretics are also advised to consult a healthcare professional before using ibuprofen, as this combination may lead to reduced diuretic efficacy and potential renal complications.

Those with a history of gastrointestinal issues, such as heartburn, should seek medical advice before using ibuprofen due to the potential for exacerbation of these conditions.

Furthermore, patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should consult a healthcare provider prior to using ibuprofen to ensure safe and appropriate use.

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 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, specifically those aged 60 years and older, are advised to discontinue use and consult a healthcare provider. This precaution underscores the importance of careful monitoring and assessment of treatment in this population, as they may be at increased risk for adverse effects or complications. Healthcare providers should consider these factors when prescribing and managing therapy for geriatric patients to ensure safety and efficacy.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is crucial 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. The potential adverse effects on fetal outcomes necessitate careful consideration and professional guidance in managing pain or inflammation during 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 during the last three months of pregnancy unless explicitly 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 while breastfeeding.

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 recommended to ensure safety and efficacy in this population. Additionally, healthcare professionals should remain vigilant for potential adverse effects in patients with concurrent conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may further complicate the management of therapy in individuals with renal impairment.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. 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 or significant hepatic impairment, 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 a history of liver disease, such as cirrhosis, should be evaluated for potential contraindications and the need for alternative therapeutic options. It is crucial to consider the overall health status of patients, including any comorbid conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these may further complicate treatment decisions in the context of hepatic impairment.

Overdosage

Overdosage of ibuprofen can lead to significant health risks and serious harm. Healthcare professionals should be aware of the potential symptoms and recommended actions in the event of an overdose.

Symptoms of Overdose Patients experiencing an ibuprofen overdose may present with a range of symptoms, including nausea, vomiting, stomach pain, drowsiness, headache, and confusion. It is crucial for healthcare providers to recognize these signs promptly to ensure appropriate intervention.

Recommended Actions In the event of an overdose, it is imperative to seek immediate medical attention. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center for guidance on managing the situation effectively. Timely intervention can mitigate the risks associated with ibuprofen overdosage and improve patient outcomes.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or 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 current information.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and are included for informational purposes.

Patient Counseling

Healthcare providers should advise patients to take the medication with food or milk if they experience any stomach upset. This guidance is important to help minimize gastrointestinal discomfort and enhance tolerability of the treatment. It is essential for patients to understand the significance of this instruction to ensure optimal use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

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)