Foster and Thrive Ibuprofen

Description

Foster & Thrive™ Ibuprofen Liquid-Gels contain solubilized ibuprofen at a dosage of 200 mg per capsule. These liquid-filled capsules serve as a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. The product is gluten-free and is available in a package containing 160 liquid gels. The formulation is comparable to Advil® Liqui-Gels® in terms of active ingredient efficacy.

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 for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any 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 of such reactions can 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 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 blood thinners (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 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 these medications in excess of the recommended dosage or for extended periods.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, previous adverse reactions to pain relievers or fever reducers, a history of gastrointestinal issues such as heartburn, or pre-existing conditions including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients taking diuretics should also seek medical advice before use.

Furthermore, it is essential for patients to consult a healthcare provider or pharmacist before using ibuprofen if they are under medical care for any serious condition, are taking aspirin for the prevention of heart attack or stroke (as ibuprofen may diminish the cardioprotective effects of aspirin), or are using any other medications.

In the case of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients should discontinue use and contact 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. Additionally, symptoms indicative of heart problems or stroke, including 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 is associated with an increased risk of severe stomach bleeding, particularly 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. Signs of stomach bleeding may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries warnings regarding the potential for heart attack, heart failure, and stroke, which can be fatal. The risk of these cardiovascular events is heightened with prolonged use or higher than recommended dosages.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, symptoms indicative of heart problems or stroke (such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling), worsening pain lasting more than 10 days, fever persisting beyond 3 days, redness or swelling in the affected area, or the emergence of any new symptoms.

Before initiating treatment with ibuprofen, patients should seek medical advice if they have a history of stomach bleeding, serious side effects from pain relievers or fever reducers, or conditions such as 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 consult with a healthcare provider, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, concurrent use of ibuprofen with aspirin for these indications is not recommended.

When considering the use of ibuprofen in patients on anticoagulants or steroid medications, caution is advised due to the potential for increased risk of bleeding or gastrointestinal complications. Close monitoring of the patient's clinical status is recommended.

Additionally, the concomitant use of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen, should be approached with caution. The risk of adverse effects may be heightened, and it is advisable to avoid the use of multiple NSAIDs simultaneously.

Patients taking diuretics should also exercise caution when using ibuprofen, as NSAIDs can potentially reduce the effectiveness of diuretics and may lead to fluid retention. Monitoring of renal function and blood pressure is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Foster and Thrive 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 while symptoms persist. If pain or fever does not adequately respond to 1 capsule, a dose of 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, particularly those aged 60 years and older, should consult a healthcare provider prior to using this medication. It is recommended that the smallest effective dose be utilized in this population to minimize the risk of adverse effects and ensure safety. Careful monitoring and consideration of individual health status are essential when prescribing to geriatric patients.

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 specifically directed by a physician. The use of ibuprofen during this period may pose risks to the developing fetus and could lead to complications during delivery. Therefore, healthcare providers should carefully evaluate the potential benefits and risks before recommending this medication to pregnant patients.

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 pregnancy 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, healthcare providers should carefully consider the potential risks and benefits when advising lactating mothers.

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 and any potential risks associated with the medication. Monitoring of liver function may be necessary to ensure safety and efficacy. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate the overall health status of patients with compromised liver function before initiating therapy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment of the patient is essential to determine the appropriate course of action.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient’s vital signs and clinical status is recommended to ensure prompt identification and management of any complications that may arise.

In summary, immediate medical attention and appropriate management strategies are vital in addressing overdose cases effectively.

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

During postmarketing experience, the following adverse reactions have been reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, blisters, leg swelling, worsening pain lasting more than 10 days, fever worsening or persisting for more than 3 days, redness or swelling in the painful area, and the appearance of any new symptoms.

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. Patients should be informed of the signs of stomach bleeding and instructed to discontinue use and consult a doctor if they experience any of the following symptoms: feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, patients should be made aware of symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. They should also be cautioned to seek medical advice if pain worsens or persists for more than 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.

Patients should be instructed to take the product with food or milk if they experience stomach upset. It is important for healthcare providers to recommend that patients consult a doctor before use if any of the following apply: they have a history of stomach bleeding, have experienced serious side effects from pain relievers or fever reducers, have a history of stomach problems such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients taking diuretics should also be advised to seek medical guidance prior to use.

Furthermore, healthcare providers should encourage patients to consult a doctor or pharmacist before using the product if they are under medical care for any serious condition, are taking aspirin for heart attack or stroke (as ibuprofen may reduce the effectiveness of aspirin), or are taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a 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). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)