Sound Body Ibuprofen

Description

SOUND BODY™ is a nonsteroidal anti-inflammatory drug (NSAID) containing ibuprofen as its active ingredient, which serves as a pain reliever and fever reducer. Each liquid-filled capsule contains 200 mg of ibuprofen, and the product is available in a package of 40 capsules. This formulation is comparable to the active ingredient found in Advil® Liqui-Gels®. The product is distributed by Allegiant Health, located in Deer Park, NY 11729. It is important to note that this product is not manufactured or distributed by Pfizer Consumer Healthcare, the owner of the registered trademark Advil® Liqui-Gels®. The product is identified with V#5003620 and ITEM#FP0647, and it is a product of India.

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

Adults and children aged 12 years and older are advised to take 1 softgel every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 softgel, a dosage of 2 softgels may be administered. It is imperative that the total daily dosage does not exceed 6 softgels within a 24-hour period unless specifically 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 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 medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with a 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.

NSAIDs, excluding aspirin, are also linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. The risk is particularly elevated in patients who use these medications in excess of the recommended dosage or for prolonged periods.

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 physician if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, patients should seek medical advice if they exhibit symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, leg swelling, worsening pain lasting more than 10 days, fever persisting beyond three days, redness or swelling in the affected area, or the emergence of any new symptoms.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

Severe allergic reactions may occur, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), carries a 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, 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 the medication beyond the directed dosage or duration.

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, leg swelling, worsening pain lasting more than 10 days, fever lasting more than three days, redness or swelling in the painful area, or the emergence of any new symptoms, should also prompt immediate medical consultation.

Before using ibuprofen, patients should seek medical advice if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also important for patients taking diuretics or those under a physician's care for serious conditions to consult with a healthcare provider prior to use. Furthermore, individuals taking aspirin for heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

The concomitant use of ibuprofen with aspirin for the prevention of heart attack or stroke may diminish the cardioprotective effects of aspirin. Therefore, it is advisable to avoid the simultaneous administration of these medications to ensure optimal therapeutic outcomes.

When ibuprofen is used in conjunction with anticoagulants or steroid medications, there is an elevated risk of gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring patients closely for signs of bleeding when these drugs are prescribed together.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, is associated with an increased risk of cardiovascular events such as heart attack and stroke. This risk is particularly pronounced when NSAIDs are used in higher doses or for extended periods. It is recommended that healthcare providers assess the necessity of NSAID therapy and consider alternative treatments when appropriate to mitigate these risks.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Sound Body Ibuprofen (ibuprofen 200 mg). 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 softgel every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 softgel, 2 softgels may be administered. It is important not to exceed 6 softgels in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing medications that may exacerbate this condition.

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 prolonged periods. It is crucial for healthcare providers to monitor these patients closely and to ensure adherence to prescribed dosages to mitigate these risks.

Furthermore, it is advisable for elderly patients to consult with their healthcare provider prior to use if they have a history of high blood pressure, heart disease, liver cirrhosis, or kidney disease, as these conditions may be more prevalent in this population and could influence the safety and efficacy of the treatment.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, especially if they are in the later stages of pregnancy or breastfeeding. It is particularly important to avoid the use of ibuprofen after 20 weeks of gestation unless explicitly directed by a physician. The use of ibuprofen during pregnancy may pose risks to the unborn child and could lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for women of childbearing potential when contemplating the use of this medication.

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 ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential to assess liver function and consider potential dosage adjustments or monitoring requirements based on the severity of hepatic impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of an overdose can vary significantly depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented as soon as possible to mitigate potential risks and complications associated with the 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 non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports include gastrointestinal bleeding, renal impairment, and cardiovascular events. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Additionally, cases of liver enzyme elevations and liver failure have been reported. Anaphylactic reactions, including angioedema and bronchospasm, have been noted in the postmarketing setting. Furthermore, there are reports of hypertension and heart failure associated with the use of ibuprofen.

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 crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset. This guidance can help mitigate gastrointestinal discomfort and enhance the overall tolerability of the treatment.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20-25 °C (68-77 °F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the seal under the bottle cap is broken or missing, as this may compromise the product's safety and effectiveness. Proper handling and storage conditions are crucial to ensure the quality of the product throughout its shelf life.

Additional Clinical Information

Patients aged 12 years and older are advised to take 1 softgel every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 softgel, a maximum of 2 softgels may be administered. However, the total dosage should not exceed 6 softgels within a 24-hour period unless specifically directed by a healthcare professional. For children under 12 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a healthcare professional before using this medication. It is particularly crucial to avoid ibuprofen use after 20 weeks of pregnancy unless explicitly instructed by a doctor, 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 Sound Body Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)