365 Whole Foods Market Ibuprofen

Description

Ibuprofen Tablets contain 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. These tablets are designed to provide effective analgesic and antipyretic properties. The formulation is comparable to the active ingredient found in Advil. Each bottle contains 100 coated tablets, ensuring convenient dosing and storage.

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

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 the medication 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 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, 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 may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are aged 60 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 the medication in excess of the recommended dosage 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, weakness on one side of the body, 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 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Drug Interactions

Ibuprofen has several notable drug interactions that may impact its efficacy and safety profile.

Anticoagulants and Steroids Ibuprofen may interact with anticoagulant medications and steroid drugs, potentially increasing the risk of bleeding. Patients on these medications should be closely monitored for any signs of adverse effects.

Aspirin The concurrent use of ibuprofen may diminish the cardioprotective effects of aspirin when aspirin is used for the prevention of heart attack or stroke. It is advisable for patients to consult their healthcare provider regarding the timing and dosing of these medications to optimize therapeutic outcomes.

Other NSAIDs The use of ibuprofen in conjunction with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin and naproxen, is not recommended. This combination may increase the risk of gastrointestinal adverse effects and renal impairment.

Diuretics Patients who are taking diuretics should seek medical advice before using ibuprofen. The combination may lead to reduced diuretic efficacy and potential renal complications, necessitating careful monitoring and possible dosage adjustments.

Packaging & NDC

Below are the non-prescription pack sizes of 365 Whole Foods Market 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 children aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. However, the total dosage must not exceed 6 tablets in a 24-hour period unless 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, are at an increased risk for 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, 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 amplified in elderly patients who exceed the recommended dosage or duration of therapy. Therefore, careful assessment of the benefits and risks, along with appropriate dose 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 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 evaluate the potential benefits and risks when considering the use of ibuprofen in this population.

Lactation

Lactating mothers are advised to 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 unborn child or lead to complications during delivery. There is no specific data available 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 a history of kidney disease. It is essential to assess renal function and consider any potential dosing adjustments or monitoring requirements based on the severity of renal impairment. Additionally, patients with reduced kidney function may have an increased risk of adverse effects, necessitating careful evaluation of their overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke.

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 function periodically during therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary, and careful consideration should be given to the severity of hepatic impairment when determining the appropriate dose. Patients with significant liver dysfunction may require closer monitoring for efficacy and safety, as the risk of adverse effects may be increased.

Additionally, patients with a history of liver disease, including cirrhosis, should be evaluated for potential drug interactions and contraindications, particularly if they also have comorbid conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke. Regular assessment of liver function tests is recommended to ensure ongoing safety and effectiveness of the treatment in this population.

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 overdose situations, as timely medical help can significantly influence 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 may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate 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

No specific postmarketing experience details are provided in the available data.

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.

Patients should be encouraged to consult with their healthcare provider before using this medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Additionally, it is important for patients to discuss their medical history with their healthcare provider, particularly if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them.

Healthcare providers should also inquire about any existing conditions that may affect the use of this medication, including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients taking diuretics should be advised to consult their healthcare provider prior to use.

Furthermore, patients should be informed that if they are taking aspirin for heart attack or stroke prevention, they should speak with their doctor or pharmacist, as ibuprofen may reduce the effectiveness of aspirin. It is also essential for patients under a doctor's care for any serious condition to seek guidance from their healthcare provider before using this medication. Lastly, patients should be encouraged to discuss any other medications they are currently taking with their healthcare provider or pharmacist to ensure safe 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 quality assurance, the lot number and expiration date can be found on the end panel of the packaging.

Additional Clinical Information

Patients should take the medication orally, with a recommended dosage of 1 tablet every 4 to 6 hours as needed for symptom relief. If symptoms persist and do not respond to 1 tablet, a maximum of 2 tablets may be taken. However, patients should not exceed 6 tablets within a 24-hour period unless directed by a healthcare professional.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional before use. It is particularly important to avoid ibuprofen 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 (1-800-222-1222) in the event of an overdose.

Drug Information (PDF)

This file contains official product information for 365 Whole Foods Market Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)