Dg Health Ibuprofen

Description

DG™|health Ibuprofen Tablets are formulated as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 200 mg of ibuprofen, comparable to the active ingredient found in Advil® Ibuprofen Caplets. The product is presented in a package containing 50 capsule-shaped tablets, designed for ease of swallowing. The actual size of each caplet is consistent with standard formulations for this dosage form.

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 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does not exceed 6 caplets 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 ibuprofen or 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 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.

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated 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.

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 heightened with the use of higher than recommended doses or prolonged use.

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 (1-800-222-1222).

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, vomiting blood, passing 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 vary in 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, are 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 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 their 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 a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended to seek advice if taking a diuretic or if under a physician's care for any serious condition.

Patients taking aspirin for heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin and should consult a healthcare professional before use.

Drug Interactions

The use of ibuprofen is associated with several important drug interactions that may affect its efficacy and safety profile.

Pharmacodynamic Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when both medications are taken concurrently for the prevention of heart attack or stroke. Therefore, patients should be advised to avoid the simultaneous use of ibuprofen and aspirin for these indications.

Additionally, the concomitant use of ibuprofen with anticoagulants or steroid medications may elevate the risk of bleeding. Clinicians should monitor patients closely for signs of bleeding and consider alternative pain management strategies if necessary.

Pharmacokinetic Interactions

The co-administration of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin and naproxen, can significantly increase the risk of gastrointestinal bleeding. It is advisable to avoid the use of multiple NSAIDs simultaneously.

Furthermore, caution is warranted when ibuprofen is used alongside diuretics, as interactions may occur that could affect the efficacy of diuretic therapy.

Patients with serious medical conditions should consult their healthcare provider prior to initiating ibuprofen therapy to ensure safe and effective 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 and adults aged 12 years and older, the recommended dosage is 1 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. However, the total daily dosage must not exceed 6 caplets within a 24-hour period unless otherwise directed by a healthcare provider.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

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 consider this heightened risk when prescribing and monitoring treatment in this population.

Additionally, nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of aspirin, are associated with an elevated risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is further amplified in elderly patients who exceed the recommended dosage or duration of use. Therefore, careful assessment of the benefits and risks, along with appropriate dosage adjustments and close monitoring, is advised for geriatric patients receiving NSAIDs.

Pregnancy

Pregnant patients and women of childbearing potential should consult a healthcare 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 developing fetus and lead to complications during delivery. The potential fetal impacts associated with ibuprofen use during late pregnancy warrant careful consideration and professional guidance.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication while breastfeeding. There is a particular concern regarding the use of ibuprofen during pregnancy, especially after 20 weeks, as it may pose risks to the unborn child and lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for lactating mothers considering this treatment.

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 pharmacokinetics, 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 impairment, particularly those with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. 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.

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 require additional considerations in management.

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 to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is vital for healthcare providers to remain vigilant and prepared to implement necessary interventions based on the clinical presentation of the patient.

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 current information.

Postmarketing Experience

During postmarketing use of ibuprofen, the following adverse reactions have been reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including instances of anaphylaxis and serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Cardiovascular events, including heart attack and stroke, have also been documented. Gastrointestinal complications, such as bleeding, ulceration, and perforation, have been reported.

Liver damage, including cases of liver failure, and kidney damage, including acute kidney injury, have been observed. Additionally, hypertension and exacerbation of asthma have been reported. Other serious adverse reactions include, but are not limited to, dizziness, headache, and tinnitus.

Patient Counseling

Patients should be advised 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.

Healthcare providers should encourage patients to consult 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 this medication. Furthermore, it is important for patients to discuss their use of diuretics with their healthcare provider prior to use.

Patients taking aspirin for heart attack or stroke should be cautioned to speak with a doctor or pharmacist before using this medication, as ibuprofen may reduce the effectiveness of aspirin in these situations. Lastly, patients under a doctor's care for any serious condition or those taking any other medications should be encouraged to consult their healthcare provider or pharmacist before use.

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). 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

Patients should be informed that the medication is administered orally, with a recommended dosage of one caplet every 4 to 6 hours as needed for symptom relief. If symptoms persist and do not respond to one caplet, two caplets may be taken. However, the total daily dosage should not exceed six caplets within a 24-hour period unless otherwise directed by a healthcare professional.

Clinicians should counsel patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen use after 20 weeks of pregnancy unless specifically instructed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should keep the medication out of reach of children and seek immediate medical assistance or contact a Poison Control Center at 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)