Ibuprofen

Description

Meijer® ibuprofen oral suspension is formulated for children ages 2 to 11 years. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) that serves as a pain reliever and fever reducer. The product is designed to provide relief for up to 8 hours and is available in a berry flavor. This formulation is alcohol-free and paraben-free, ensuring a suitable option for pediatric use. The total volume of the product is 4 FL OZ (120 mL).

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in children, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the child's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be used for accurate measurement; no other dosing devices should be utilized.

For children weighing under 24 lbs (under 2 years), it is advised to consult a doctor for appropriate dosing. For children weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (4-5 years), the dose increases to 7.5 mL. Children weighing 48-59 lbs (6-8 years) should receive 10 mL, while those weighing 60-71 lbs (9-10 years) should be given 12.5 mL. For children weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

Dosing may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly. To maintain child resistance, the original bottle cap should be replaced securely after each use. It is critical to adhere to the recommended dosing guidelines and not exceed the directed amount.

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 in the perioperative period surrounding heart surgery due to potential complications.

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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of such an event is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment increases this risk.

NSAIDs, with the exception of aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, as these may indicate a serious condition. Consultation with a physician is advised promptly. The use of this medication should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

It is crucial to discontinue use and consult a physician if the child exhibits any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, signs of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, a healthcare provider should be consulted. Any new symptoms that arise should also prompt a medical evaluation.

In cases of overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in severity.

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 with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

There is also an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, associated with the use of NSAIDs, excluding aspirin. These events can be fatal, particularly when the medication is used in excess of the recommended dosage or duration.

Patients should be vigilant for severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical attention. It is advised not to use ibuprofen for more than two days or in children under three years of age without a doctor's direction.

Parents should discontinue use and consult a healthcare professional if their child exhibits 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, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical evaluation. Furthermore, if the child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt consultation with a healthcare provider.

Before administering ibuprofen, it is crucial to consult a doctor if the child has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, children with asthma or those taking diuretics should seek medical advice prior to use. It is also recommended to consult a healthcare professional if the child is under treatment for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to such patients.

In terms of pharmacodynamic interactions, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. This risk is further compounded when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

Given these interactions, it is advisable for healthcare providers to closely monitor patients who are prescribed ibuprofen, especially if they are concurrently taking anticoagulants, steroids, or other NSAIDs. Consultation with a physician is recommended if the patient is on any additional medications to ensure safe and effective use of ibuprofen.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 3 years of age should not use this product unless directed by a doctor. For children aged 2 to 11 years, dosing is based on weight and age, as follows:

• Under 24 lbs / Under 2 years: Ask a doctor

• 24-35 lbs / 2-3 years: 5 mL

• 36-47 lbs / 4-5 years: 7.5 mL

• 48-59 lbs / 6-8 years: 10 mL

• 60-71 lbs / 9-10 years: 12.5 mL

• 72-95 lbs / 11 years: 15 mL

It is important to not exceed a duration of use beyond 2 days or administer to children under 3 years of age without medical guidance. Prior to use, healthcare professionals should be consulted if the child is under a doctor's care for any serious condition or is taking any other medications.

Monitoring for adverse effects is crucial. Parents or caregivers should discontinue use and seek medical advice if the child exhibits signs of stomach bleeding (e.g., faintness, vomiting blood, black or bloody stools, persistent stomach pain), symptoms indicative of heart problems or stroke (e.g., chest pain, difficulty breathing, unilateral weakness, slurred speech, leg swelling), or if there is no relief within the first 24 hours of treatment. Additionally, if fever or pain worsens or persists beyond 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical consultation is advised.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center (1-800-222-1222) is recommended. Only the enclosed dosing cup should be used for administration; other dosing devices are not appropriate.

Geriatric Use

Elderly patients may present with comorbidities such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, which can complicate the use of this product. It is important to note that this product does not contain specific directions or complete warnings for adult use, including geriatric patients.

Healthcare providers should exercise caution when prescribing this product to elderly patients, considering the potential for altered pharmacokinetics and increased sensitivity to adverse effects. Close monitoring of these patients is recommended to ensure safety and efficacy, particularly in those with the aforementioned health conditions.

Due to the lack of specific guidance for geriatric use, dosage adjustments may be necessary based on individual patient assessments and clinical judgment.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during pregnancy may pose risks, including potential cardiovascular effects on the developing fetus. Pregnant women should avoid using ibuprofen unless directed by a healthcare professional. It is essential for healthcare providers to consult with patients regarding appropriate use and dosage modifications during pregnancy to ensure maternal and fetal safety.

Lactation

Nursing mothers should consult a doctor before using ibuprofen. There is a potential for excretion of ibuprofen in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the nursing infant for any adverse effects if the mother is taking ibuprofen.

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, or liver cirrhosis, as these 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 may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients 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 throughout the treatment course.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. It is crucial to consider the overall health status of these patients, including any coexisting conditions such as high blood pressure, heart disease, or kidney disease, which may further complicate their treatment regimen.

Healthcare providers should exercise caution and tailor the treatment plan based on the individual patient's liver function and overall health profile.

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 attention 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

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Allergic reactions, including hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters, have been reported in the postmarketing experience. Serious adverse reactions such as headache, nausea, and vomiting may also occur. A warning regarding stomach bleeding is applicable to children with a history of stomach problems, including heartburn, or those who have experienced serious side effects from pain relievers or fever reducers.

Additionally, symptoms indicative of heart problems or stroke have been reported, including chest pain, difficulty breathing, unilateral weakness, slurred speech, and leg swelling. There have been reports of fever or pain worsening or persisting for more than three days. New symptoms emerging during treatment have also been documented.

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 to administer the medication with food or milk if the patient experiences stomach upset.

Providers should encourage patients to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if there is a concern regarding stomach bleeding. Additionally, it is important to discuss the child's fluid intake; patients should be advised to seek medical advice if the child has not been drinking fluids or has lost a significant amount of fluid due to vomiting or diarrhea.

Healthcare providers should also inquire about any pre-existing conditions. Patients should be advised to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has experienced a stroke. Furthermore, if the child has asthma or is taking a diuretic, it is essential to seek medical advice prior to use.

Lastly, patients should be encouraged to discuss any other medications the child is taking or if the child is under a doctor's care for any serious condition with their healthcare provider or pharmacist before using this medication.

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. Freezing the product is strictly prohibited, as it may compromise its quality.

Healthcare professionals should ensure that the product is not utilized if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial for optimal product performance.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to take the medication with food or milk if gastrointestinal upset occurs.

Patient counseling should emphasize the importance of keeping the medication out of reach of children and the necessity of seeking immediate medical assistance or contacting a Poison Control Center (1-800-222-1222) in the event of an overdose. Patients are instructed to use only the enclosed dosing cup for administration and to wash it after each use to ensure proper hygiene.

Drug Information (PDF)

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

View product document (PDF)